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The effectiveness of pressure garment therapy for the prevention of abnormal scarring after burn injury: A meta-analysis
Abstract
This study had three objectives. First, to conduct a systematic review to identify the available evidence for the use of pressure garment therapy (PGT); second, to assess the quality of the available evidence; and third, to conduct a meta-analysis to quantify the effectiveness of PGT for the prevention of abnormal scarring after burn injury.
Standard care for the prevention of abnormal scarring after burn injury includes pressure garment therapy (PGT); however, it is associated with potential patient morbidity and high costs. We hypothesise that an assessment of the available evidence supporting the use of pressure garment therapy will aid in directing clinical care and future research.
Randomised control trials were identified from CINHAL, EMBASE, MEDLINE, CENTRAL, the 'grey literature' and hand searching of the Proceedings of the American Burn Association. Primary authors and pressure garment manufacturers were contacted to identify eligible trials. Bibliographies from included studies and reviews were searched. Study results were pooled to yield weighted mean differences or standardised mean difference and reported using 95% confidence intervals.
The review incorporated six unique trials involving 316 patients. Original data from one unpublished trial were included. Overall, studies were considered to be of high methodological quality. The meta-analysis was unable to demonstrate a difference between global assessments of PGT-treated scars and control scars [weighted mean differences (WMD): -0.46; 95% confidence interval (CI): -1.07 to 0.16]. The meta-analysis for scar height showed a small, but statistically significant, decrease in height for the PGT-treated group standardised mean differences (SMD): -0.31; 95% CI: -0.63, 0.00. Results of meta-analyses of secondary outcome measures of scar vascularity, pliability and colour failed to demonstrate a difference between groups.
PGT does not appear to alter global scar scores. It does appear to improve scar height, although this difference is small and of questionable clinical importance. The beneficial effects of PGT remain unproven, while the potential morbidity and cost are not insignificant. Given current evidence, additional research is required to examine the effectiveness, risks and costs of PGT.
... [Santuzzi CH, Gonçalves Liberato FM, Fachini de Oliveira NF, Sgrancio do Nascimento A, Nascimento LR (2024) Massage, laser and shockwave therapy improve pain and scar pruritus after burns: a systematic review. Journal of Physiotherapy 70: [8][9][10][11][12][13][14][15] ...
... For instance, the International Society for Burns Injuries Practice Guidelines for Burn Care advises that non-invasive techniques are important additional elements of a comprehensive post-burn pain management plan. 11 Three previous systematic reviews 9,12,13 have addressed noninvasive therapies in people with burn injuries. The first review 12 suggested that pressure garment therapy produces negligible benefits on scars, but the conclusions were based on non-randomised trials. ...
... 11 Three previous systematic reviews 9,12,13 have addressed noninvasive therapies in people with burn injuries. The first review 12 suggested that pressure garment therapy produces negligible benefits on scars, but the conclusions were based on non-randomised trials. The second review 13 summarised the non-invasive treatments, but conclusions were based on qualitative description of results from non-randomised trials. ...
... [Santuzzi CH, Gonçalves Liberato FM, Fachini de Oliveira NF, Sgrancio do Nascimento A, Nascimento LR (2024) Massage, laser and shockwave therapy improve pain and scar pruritus after burns: a systematic review. Journal of Physiotherapy 70: [8][9][10][11][12][13][14][15] ...
... For instance, the International Society for Burns Injuries Practice Guidelines for Burn Care advises that non-invasive techniques are important additional elements of a comprehensive post-burn pain management plan. 11 Three previous systematic reviews 9,12,13 have addressed noninvasive therapies in people with burn injuries. The first review 12 suggested that pressure garment therapy produces negligible benefits on scars, but the conclusions were based on non-randomised trials. ...
... 11 Three previous systematic reviews 9,12,13 have addressed noninvasive therapies in people with burn injuries. The first review 12 suggested that pressure garment therapy produces negligible benefits on scars, but the conclusions were based on non-randomised trials. The second review 13 summarised the non-invasive treatments, but conclusions were based on qualitative description of results from non-randomised trials. ...
... Conservative treatments, including scar massage, scar tissue moisturization and compression, are fundamental principles for scar treatment 114 . Massage 110,115 and compression 111,116,117 are central treatment approaches in burn injuries and have been shown in large trials to be very effective, and these treatment options should also be used in hypertrophic scars and keloid lesions. ...
... The aim is to diagnose those who would heal in a timely fashion, for example, within 14 days, such that a conservative path is followed. Those who would take more than 14 days will have an increasing risk of poor scar outcome, and early identification will facilitate early surgery within 7 days 116 . ...
Wound healing occurs as a response to disruption of the epidermis and dermis. It is an intricate and well-orchestrated response with the goal to restore skin integrity and function. However, in hundreds of millions of patients, skin wound healing results in abnormal scarring, including keloid lesions or hypertrophic scarring. Although the underlying mechanisms of hypertrophic scars and keloid lesions are not well defined, evidence suggests that the changes in the extracellular matrix are perpetuated by ongoing inflammation in susceptible individuals, resulting in a fibrotic phenotype. The lesions then become established, with ongoing deposition of excess disordered collagen. Not only can abnormal scarring be debilitating and painful, it can also cause functional impairment and profound changes in appearance, thereby substantially affecting patients' lives. Despite the vast demand on patient health and the medical society, very little progress has been made in the care of patients with abnormal scarring. To improve the outcome of pathological scarring, standardized and innovative approaches are required.
... A consensus is needed regarding what to assess in research studies, which tools and measures to use and at what time points. Presently, clinical research assessments of scar management interventions focus more predominantly on measures of scarring and individual scar features [2][3][4]. Systematic reviews demonstrate that judgements of the efficacy of pressure garment therapy (PGT), one mainstay of scar management, have largely been made according to scar outcomes including the use of aggregate scar scales and individual measures, such as scar thickness, colour and pliability [2,3]. However, patients experience scarring and scar management therapies much more broadly, and a patient-centred evaluation of scar management interventions should reflect this. ...
... Presently, clinical research assessments of scar management interventions focus more predominantly on measures of scarring and individual scar features [2][3][4]. Systematic reviews demonstrate that judgements of the efficacy of pressure garment therapy (PGT), one mainstay of scar management, have largely been made according to scar outcomes including the use of aggregate scar scales and individual measures, such as scar thickness, colour and pliability [2,3]. However, patients experience scarring and scar management therapies much more broadly, and a patient-centred evaluation of scar management interventions should reflect this. ...
Presently, research assessments of burn scar management interventions focus on measures of scarring and scar features. However, qualitative research demonstrates that patients experience scarring and scar management therapies holistically. Patient-centred assessment should reflect this. An agreement is required regarding what to assess, which tools and measures to use and at what time points. Key issues include (1) whether and how burn- or scar-related quality-of-life measures could be included in the assessment of scar management interventions and how these are weighed against scar measures; (2) routine inclusion of the assessment of treatment burden (or treatment experience) in comparative research and (3) generating further understanding of the relationship between scar management and psychosocial adaptation, along with an assessment of this. A debate concerning a holistic and standardized evaluation of scar management interventions is needed to ensure that future evidence-based decisions are made in a patient-centred manner.
... 20 Pressure garments are fabricated to deliver positive pressure to the skin; however, the optimal magnitude of pressure required for effective scar prevention is debated. 18,21,22 Low to mid-range pressures (15-24 mmHg) have been reported effective in some studies, while others propose that applied pressure must exceed capillary pressure (*25 mmHg) to be effective. 22,23 Two methods of garment fabrication are most commonly used to generate the target pressure: the Reduction Factor method and the Laplace's Law method. ...
... 76 An earlier meta-analysis, which had only reported minimal benefits associated with pressure therapy, had only been able to include six RCTs. 21 However, the larger sample size, and the stability of the pooled results when subjected to sensitivity analyses, in addition to no obvious publication bias, suggests that this more recent metaanalysis is reliable. ...
Significance:
The physical and psychological sequalae of burn injuries account for 10 million disability-adjusted life years lost annually. Hypertrophic scarring (HSc) following burn injury results in reduced mobility, contracture, pain, itching, and aesthetic changes for burn survivors. Despite the prevalence of scarring and the number of scar therapies available, none are highly effective at preventing HSc following burn injury. Recent Advances: Recent studies modulating the mechanical environment surrounding incisional and excisional wounds have shown off-loading of tension to be a powerful strategy to prevent scar formation. Preclinical studies applying force perpendicular to the surface of the skin or using a combination of pressure both circumferentially and perpendicularly have shown substantial reductions in scar thickness and contraction following burn injury.
Critical issues:
Though pressure therapy is highly effective in preclinical studies, outcomes in clinical studies have been variable and may be a result of differing therapy protocols and garment material fatigue. A recent adult clinical study reported a significant reduction in pressure after one month of use and significant reduction between one and two months of use, resulting in below therapeutic doses of pressure applied after only one month of use Future Directions: To enhance efficacy of pressure garments, new low-fatigue materials must be developed for use in standard garments or garments must be redesigned to allow for adjustment to compensate for the loss of pressure with time. Additionally, measurements of applied pressure should be performed routinely during clinic visits to ensure that therapeutic doses of pressure are being delivered.
... Current treatments for contracted skin include nonsurgical solutions (such as pressure garments and splints) or surgical correction [5]. Surgical corrections such as skin grafts, z-plasty, adjacent tissue rearrangement, and flap surgery are often used in combination with postoperative physical and occupational therapy. ...
Skin contracts during wound healing to facilitate wound closure. In some patients, skin contraction can lead to the formation of skin contractures that limit movement, impair function, and significantly impact well-being. Current treatment options for skin contractures are burdensome for patients, and there is a high risk of recurrence. Autologous fat grafting can improve the structure and function of scarred skin; however, relatively little is known about the effect of fat on skin contraction. In this study, an in vitro tissue-engineered model of human skin was used to test the effects of adipose tissue and adipose-derived stromal cells on skin contraction. Untreated tissue-engineered skin contracted to approximately 60% of the original area over 14 days in culture. The addition of adipose tissue reduced this contraction by 50%. Adipose tissue, which was emulsified or concentrated and high doses of adipose-derived stromal cells (ADSC) were able to inhibit contraction to a similar degree; however, lower doses of ADSC did not show the same effect. In conclusion, the subcutaneous application of adipose tissue has the potential to inhibit skin contraction. This study provides in vitro evidence to support the use of autologous fat grafting to prevent skin contraction in patients most at risk.
... This was confirmed in 2012 through a survey of American occupational therapists, who agreed with the findings on improved appearance (85%), contractures/movement (71%) and a reduction of itchiness (65%) 2 . Anzarut et al 3 4 agreed that the effectiveness of PGT has not been firmly established. ...
Introduction: Pressure garment therapy is used to treat hypertrophic scars, but adherence to this intervention presents challenges. The aim of the paper was to explore the pressure garment therapy experiences of adult burn survivors.Methods: The experiences of eight purposively sampled participants were explored in a qualitative, phenomenological study. Data were collected by means of semi-structured interviews. Thematic analysis was conducted.Results: Participants described an improvement in the scars, but struggled with adherence to pressure garment therapy. The emotional impact of the burn injury, physical symptoms, the effort of caring for the garments and aesthetic factors created barriers to adherence. Support, inner strength, knowledge, and seeing an improvement facilitated adherence.Conclusion: The findings of the study show that participants perceived pressure garment therapy as beneficial, but several complex factors impacted adherence. A bigger choice in material colours, a person-centred approach to burn management, digital photos of scars to catalogue improvement and the establishment of a counselling network are recommended. Keywords: Burns, hypertrophic scars, pressure garment therapy, adherence.
... 1 Hypertrophic scars have become a major skin complication that seriously affect the physical and mental health of patients with burns, trauma, and surgery in recent years. 2,3 There are various methods to treat scars, such as surgical excision, 4 pressure treatment, 5 silicone gel dressings, 6 5-fluorouracil, 7 laser therapy, 8 radiotherapy, 9 local injection of corticosteroids, 10 and local injection of botulinum toxin. 11 However, the treatment of hypertrophic scars is still in the research stage and has great prospects. ...
Background
Multiple methods have been used to treat hypertrophic scarring; however, an optimal treatment method remains to be established. We aimed to research and compare the effects of cell-free fat extract (CEFFE) and platelet-rich fibrin (PRF) on hypertrophic scar formation based on histomorphological analysis in this study.
Methods
Twelve rabbits were divided into four groups randomly. (CEFFE+PRF group, n=3; CEFFE group, n=3, PRF group, n=3 and Control group, n=3). After the ear hypertrophic scar model were established, the two ears of each rabbit in the four groups were injected with CEFFE 0.05 mL/cm² + PRF 0.05 mL/cm², CEFFE 0.1 mL/cm², PRF 0.1 mL/cm², and saline 0.1 mL/cm², respectively. The scar elevation index and histological analysis using hematoxylin-eosin and Masson staining were evaluated after injection on day 40.
Results
The CEFFE+PRF group was significantly more effective in the prevention of pathological scar formation than the CEFFE-only, PRF-only, and control groups in terms of capillary count, collagen organization, fibroblast count, and scar elevation index (p<0.05).
Discussion
CEFFE combined with PRF was the most effective treatment for the prevention of hypertrophic scar formation in our study.
... The efficacy of these garments varies, and patient compliance can be a concern. (11) Corticosteroid injections, administered intralesionally, often with triamcinolone acetonide, are used to reduce inflammation and minimize scar thickness. However, multiple sessions may be required, and side effects like skin thinning or hypopigmentation can occur. ...
Hypertrophic scars (HS) and keloids are challenging dermatological conditions that often lead to physical and psychological distress in affected individuals. Current therapeutic approaches have limitations, prompting the exploration of novel treatments. Botulinum Neurotoxin BoNT-A has emerged as a promising candidate in managing these scars. This comprehensive review delves into the pathophysiology of HS and keloids, the shortcomings of existing treatments, and the mechanisms underlying BoNT-A's potential efficacy. Through an analysis of clinical studies and evidence, the review evaluates BoNT-A's impact on scar formation and patient outcomes. Safety and side effects and the potential influence of BoNT-A on quality of life are also considered. Comparative analysis with traditional therapies underscores the advantages and challenges of BoNT-A use. The review concludes by suggesting future research directions and emphasizing the significance of Botulinum Neurotoxin BoNT-A as a promising therapeutic option. This article provides valuable insights for clinicians, researchers, and patients seeking innovative solutions for HS and keloids.
... A wide variety of treatments have been advocated for hypertrophic scars. Among these treatments are surgical excision with or without grafting [1], pressure therapy [3], intralesional interferon [4], topical and intralesional corticosteroids [5], intralesional leomycin [6], laser therapy [7], silicone gel sheeting [8], onion extract gel and other therapies directed at collagen synthesis [9]. One of the newer modalities available is the injection of insulin in the wound at the time of repair to prevent scar formation [10]. ...
... It is hypothesized that compression decreases the proliferation of fibroblasts through ischemia, reducing the flow of both oxygen and inflammatory signals. [3] In particular, there is an increased transforming growth factor-beta (TGF-B) secretion. Higher levels of TGF-B are considered a risk factor for hypertrophic and keloid scar development. ...
Pressure garment therapy is frequently used to prevent pathologic scarring, especially in burns. Less common is its use for the treatment of facial wounds. Pathologic scarring can create functional and aesthetic problems, which can have psychological implications. The aim of this study is to report our experience in the treatment of traumatic facial wounds using an elastic custom facial mask.
... These scars are painful, hard, itchy, elevated and contracted, frequently cause significant cosmetic and symptomatic problems, and result in the loss of local function and even disability in some cases [3,4]. Clinically, hypertrophic scars can be treated in a variety of ways, including intralesional corticosteroids, topical applications, cryotherapy, surgery, laser therapy, and silicone sheeting [5][6][7][8][9][10][11][12]. However, the outcomes of these clinical treatments are not satisfactory, largely due to a lack of understanding of the pathophysiology regarding the human hypertrophic scar [13,14]. ...
The hypertrophic scar is an aberrant form of wound healing process, whose clinical efficacy is limited by a lack of understanding of its pathophysiology. Remodeling of collagen and elastin fibers in the extracellular matrix (ECM) is closely associated with scar progression. Herein, we perform label-free multiphoton microscopy (MPM) of both fiber components from human skin specimens and propose a multi-fiber metrics (MFM) analysis model for mapping the structural remodeling of the ECM in hypertrophic scars in a highly-sensitive, three-dimensional (3D) manner. We find that both fiber components become wavier and more disorganized in scar tissues, while content accumulation is observed from elastin fibers only. The 3D MFM analysis can effectively distinguish normal and scar tissues with better than 95% in accuracy and 0.999 in the area under the curve value of the receiver operating characteristic curve. Further, unique organizational features with orderly alignment of both fibers are observed in scar-normal adjacent regions, and an optimized combination of features from 3D MFM analysis enables successful identification of all the boundaries. This imaging and analysis system uncovers the 3D architecture of the ECM in hypertrophic scars and exhibits great translational potential for evaluating scars in vivo and identifying individualized treatment targets.
... 28 The optimal magnitude of pressure required for effective scar prevention has been debated with some studies reporting efficacy with 15 to 24 mmHg while others suggest that capillary pressure must be exceeded to be effective. [29][30][31][32][33][34] Designing clinical trials to examine efficacy as a function of applied pressure is challenging due to fatigue of garment materials and need for strict patient adherence to therapy. Fatigue of garments is a known problem with numerous clinical studies reporting loss of pressure with use. ...
Burn scars, and in particular, hypertrophic scars, are a challenging yet common outcome for survivors of burn injuries. In 2021, the American Burn Association brought together experts in burn care and research to discuss critical topics related to burns, including burn scars, at its State of the Science conference. Clinicians and researchers with burn scar expertise, as well as burn patients, industry representatives, and other interested stakeholders met to discuss issues related to burn scars and discuss priorities for future burn scar research. The various preventative strategies and treatment modalities currently utilized for burn scars were discussed, including relatively non-invasive therapies such as massage, compression, and silicone sheeting, as well as medical interventions such as corticosteroid injection and laser therapies. A common theme that emerged is that the efficacy of current therapies for specific patient populations is not clear, and further research is needed to improve upon these treatments and develop more effective strategies to suppress scar formation. This will necessitate quantitative analyses of outcomes and would benefit from creation of scar biobanks and shared data resources. In addition, outcomes of importance to patients, such as scar dyschromia, must be given greater attention by clinicians and researchers to improve overall quality of life in burn survivors. Herein we summarize the main topics of discussion from this meeting and offer recommendations for areas where further research and development are needed.
... Poor patient compliance detracts from study validity, as dressings should be worn at least 23 h a day at 20-40 mmHg in order to see improvement [77]. The potential morbidity and costs currently appear to outweigh its still unproven efficacy, as pressure garment therapy has not seemed to alter global scar scores compared to controls [78]. Static and dynamic splints can be tried for scars that span joints or are in areas of excessive movement to establish appropriate positioning of affected extremities during healing to prevent contractures and restore normal range of motion [79]. ...
While normal, controlled wound-healing results in scars that are nearly imperceptible, hypertrophic scars (HTS) and keloids are the result of an abnormal wound-healing process that can leave unsightly, difficult-to-treat lesions. While such scars are classically associated with surgical incisions, they may also result from burns or accidental trauma to the skin. Several different measures can be taken to prevent the formation of scars or treat those that have already formed. Prevention focuses on reducing inflammation during the wound-healing process, and minimizing tension in the lesion when appropriate. Treatments range from non-invasive modalities such as pressure therapy, topicals, and symptom management, to invasive methods such as injections, lasers, and even surgery. While some treatments, such as corticosteroid injections, have been used in the treatment of HTS and keloids for decades, other newer therapies have only been described in case reports or are still in early phases of clinical trials. Because optimal scar management will not be the same for every patient, further investigation of newer agents and methods is warranted and may benefit a great number of patients. This paper will review the evidence-based management of scars, including current widely used treatment options and promising newly emerging therapies.
... The hand and fingers are among the most challenging areas to treat due to the loss of range of motion and the complex anatomy associated with the region. Compression dressings have historically been the mainstay of treatment for minimizing hypertrophic scar formation, but meta-analysis indicates that although scar height can be reduced, there is no improvement in global scar score, pliability, vascularity, or pigmentation [4,15]. There is some evidence that silicone dressings can reduce hypertrophic scarring, but this is a topic of ongoing debate [16,17]. ...
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... They are shown to be cost ineffective 16 , though therapeutically effective when used judiciously 17 . Data regarding their reduction of excessive scarring are controversial 18 . Some patients are sensitive to silicone, whereas others cannot tolerate pressure garments. ...
This paper outlines the protocol for a study that is being carried out at multiple centres across the UK in the next three years. It is a Research for Patient Benefit (RfPB) study funded by the National Institute for Healthcare Research (NIHR). The aim is to assess the effectiveness of treating hypertrophic burns scars with pulsed dye laser (PDL) at an early stage of scar formation. The objective is to improve Quality of Life for the patient by improving both the appearance and quality of burn scarring, as well as reducing its psychological impact.
This is a parallel-arm randomised, controlled trial to compare PDL and standard care against standard care alone. The difference is measured between baseline and six-month follow-up. Recruits are within three months of healing from a burn injury; with wounds showing a defined potential for hypertrophic scarring. A total of 120 patients are recruited in a multi-centre study; with randomisation in a 1:1 allocation to each arm. The treatment arm receives 3 PDL treatments at six-week intervals in addition to standard care, whereas the control arm receives standard care alone. The primary outcome is the patient-rated part of the Patient and Observer Scar Scale (POSAS). Psychological and psycho-social impact is evaluated using the CARe burn scale (UWE, Bristol) and Quality Adjusted Life Years (QALY) is determined using the Short-Form Health Survey (SF-12). The study evaluates both the cost-effectiveness through an economic analysis and the patient-reported experience of the treatment by phone interviews.
Trial registration: ISRCTN14392301 (registered on 14 th June 2021)
Contact for Public & Scientific Queries: Mark Brewin, sft.elabs@nhs.net
Public Title: Early Laser for Burn Scars (ELABS): a trial of the effectiveness and cost of the treatment of hypertrophic burn scars with laser
Countries of Recruitment: England & Scotland
Protocol Version: v11, October 2021
... In general, scar assessment is challenging due to their great variability. [23][24][25] Until now, objective measurement tools for accurate and reproducible evaluation of scars are rare. 26 The detailed 3D-data generated by this novel technology offers new possibilities and additional evidence in clinical scar studies. ...
Background:
We tested the workflow and comparability of compression garments (CG) automatically knitted from 3D-body-scan data (3DBSD) versus manually measured data for scar treatment. Industry 4.0 has found its way into surgery, enhancing the trend toward personalized medicine, which plays an increasingly important role in CG scar therapy. Therefore, we conducted a study to evaluate the workflow from 3DBSD to fast and precisely knitted CG and compared it with standard of care.
Methods:
A randomized controlled crossover feasibility study was conducted as part of the individual medical technology research project "Smart Scar Care." Objective and patient-reported outcome measures were documented for 10 patients with hypertrophic burn scars at baseline and after wearing CG automatically knitted from 3DBSD versus CG from manually measured data for one month.
Results:
The "scan-to-knit" workflow and the study design were feasible in 10 of 10 patients. No adverse effects were found. 3DBSD showed a bias of half a centimeter compared with manually measured data and wider limits of agreement. With respect to fit, comfort, suitability, Vancouver Scar Scale, Patient and Observer Scar Assessment Scale, stiffness and microcirculation, this was a promising pilot study. Stiffness and blood flow were increased in scars compared with normal skin. The highest rank correlations were found between pain and itch, stiffness and Patient and Observer Scar Assessment Scale, Vancouver Scar Scale, and pain.
Conclusions:
These results indicate that automatically knitted CG using 3DBSD could become an alternative to the standard of care, especially with regard to economical and faster patient care. The produced scan data opens the door for objective scar science.
... 18 Pressure garments can help reduce pain and itching associated with scars, and however, the much inconvenience caused by the garments and its costs significantly decrease its compliance. 19 ...
Numerous therapeutic strategies have been described for prevention and reduction of hypertrophic scars and keloids, but none of the treatments is effective in all patients. No universal consensus in treatment regimen has been established, and there is limited evidence‐based literature to guide the correct management. The process of scar development is complex and requires deeper understanding of the molecular mechanisms that cause their development and recurrences. Despite many available modes of targeting keloid and hypertrophic scars, yet they remain an ongoing challenge to patients and clinicians. To date, no one therapy has been universally accepted as the gold standard for the treatment of all excessive scars nor has the capability of complete scar resolution The search of literature included peer‐reviewed articles including clinical trials and scientific reviews. Literature was identified from electronic databases (MEDLINE/PubMed) through May 2021 and references of respective articles and only the articles published in English language were included.
... Non-invasive options: Which include use of compression treatment (such as pressure garments with or without gel sheeting); static and dynamic splints; acrylic casts; masks and clips; application of a variety of creams, oils and lotions, silicon sheeting, with or without adhesive and hydrotherapy [1,12,13,14]. ...
Burn injuries are a pervasive clinical problem. Extensive thermal trauma can be life‐threatening or result in long‐lasting complications, generating a significant impact on quality of life for patients as well as a cost burden to the healthcare system. The importance of addressing global or systemic issues such as resuscitation and management of inhalation injuries is not disputed but is beyond the scope of this review, which focuses on cutaneous pathophysiologic mechanisms for current treatments, both in the acute and long‐term settings. Pathophysiological mechanisms of burn progression and wound healing are mediated by highly complex cascades of cellular and biochemical events, which become dysregulated in slow‐healing wounds such as burns. Burns can result in fibroproliferative scarring, skin contractures, or chronic wounds that take weeks or months to heal. Burn injuries are highly individualized owing to wound‐specific differences such as burn depth and surface area, in addition to patient‐specific factors including genetics, immune competency, and age. Other extrinsic complications such as microbial infection can complicate wound healing, resulting in prolonged inflammation and delayed re‐epithelialization. Although mortality is decreasing with advancements in burn care, morbidity from postburn deformities continues to be a challenge. Optimizing specialized acute care and late burn outcome intervention on a patient‐by‐patient basis is critical for successful management of burn wounds and the associated pathological scar outcome. Understanding the fundamentals of integument physiology and the cellular processes involved in wound healing is essential for designing effective treatment strategies for burn wound care as well as development of future therapies. Published 2018. Compr Physiol 8:371‐405, 2018.
Burn reconstruction outcomes are an area of growing investigation. Although there is evidence of measured physical improvements in scar characteristics after laser treatment, there is little information on patient reported outcomes. The purpose of this study is to compare patient reported outcomes between burn survivors with and without laser treatment. The study included participants in the Burn Model Systems National Database at a single center; participants that received outpatient laser treatment for burn scars were compared to a matched group of burn survivors that did not receive laser. The following outcomes were examined: Satisfaction With Life Scale, Mental and Physical Component Summary of the Veterans Rand Survey, and the PROMIS Pain Intensity Scale. Regression analyses examined the associations between laser treatment and each outcome at 12 and 24 months. The study population included 287 adult burn survivors (65 laser group, 222 control group). The significant differences found between the two groups included: burn size (laser: 14.9, 13.5 SD, control: 8.9, 11.1 SD; p<0.001), insurance type (p=0.036), inhalation injury (laser: 17.2%, control: 2.7%; p<0.001), and ventilator requirement (laser: 27.7%, control: 13.5%; p=0.013). Laser treatment was not associated with any of the outcomes at both follow-up time points. Further research is needed to develop patient reported outcome measures that are more sensitive to the clinical changes experienced by burn survivors receiving laser treatment.
Hypertrophic scarring is still a challenging outcome after a burn, particularly in children. Even within the pediatric population, healing and scar physiology have certain peculiarities. Factors such as the inflammatory response, characteristics of extracellular components, and the environment surrounding the injured tissue are essential to understand the scarring discrepancies between these patient populations. There are several different surgical and nonsurgical approaches available for the management of hypertrophic scars postburn. Optimal management of the initial wound environment decreases mortality and will lessen the burden of hypertrophic scarring as the wound heals and as the patient ages. The current approach is to reduce pathological scar formation with early acute surgical intervention and various nonsurgical modalities, in combination with scar revision. It is crucial to monitor and follow up children with excessive scars during their growth period. This chapter reviews distinctive aspects of hypertrophic scars that make their management so challenging and discusses techniques to improve long-term clinical outcomes.
Scars form a medical problem still considered as a cosmetic issue by most of the societies and fewly covered except for burns and trauma.
A few EBM exists on technologies used in scar management, except for silicone. Most of the treatment options are consensually used and the recommendation are to use them in combination. Scar management is based on regular scar assessment using scar scales, the patient being actor of this assessment, and the caregiver using objective measurements of volume, colour, vascularity, and elevation. An early recognition of signs of pathological scarring is mandatory to prevent important hypertrophy and keloid. Biological solutions should be considered as well as mechanical forces exerted over the scar, in order to limit fibroblast proliferation and reduce the local inflammation. Some recent consensual recommendations report good results with different types of lasers.
Objectives
Dyschromia is an understudied aspect of hypertrophic scar (HTS). The use of topical tacrolimus has successfully shown repigmentation in vitiligo patients through promotion of melanogenesis and melanocyte proliferation. It was hypothesized that HTSs treated with topical tacrolimus would have increased repigmentation compared to controls.
Methodology
Full‐thickness burns in red Duroc pigs were either treated with excision and meshed split‐thickness skin grafting or excision and no grafting, and these wounds formed hypopigmented HTSs ( n = 8). Half of the scars had 0.1% tacrolimus ointment applied to the scar twice a day for 21 days, while controls had no treatment. Further, each scar was bisected with half incurring fractional ablative CO 2 laser treatment before topical tacrolimus application to induce laser‐assisted drug delivery (LADD). Pigmentation was evaluated using a noninvasive probe to measure melanin index (MI) at Days 0 (pretreatment), 7, 14, and 21. At each timepoint, punch biopsies were obtained and fixed in formalin or were incubated in dispase. The formalin‐fixed biopsies were used to evaluate melanin levels by H&E staining. The biopsies incubated in dispase were used to obtain epidermal sheets. The ESs were then flash frozen and RNA was isolated from them and used in quantitative reverse transcription polymerase chain reaction for melanogenesis‐related genes: Tyrosinase (TYR), TYR‐related protein‐1 (TYRP1), and dopachrome tautomerase (DCT). Analysis of variance test with Šídák's multiple comparisons test was used to compare groups.
Results
Over time, within the grafted HTS and the NS group, there were no significant changes in MI, except for Week 3 in the −Tacro group. (+Tacro HTS= pre = 685.1 ± 42.0, w1 = 741.0 ± 54.16, w2 = 750.8 ± 59.0, w3 = 760.9 ± 49.8) (−Tacro HTS= pre = 700.4 ± 54.3, w1 = 722.3 ± 50.7, w2 = 739.6 ± 53.2, w3 = 722.7 ± 50.5). Over time, within the ungrafted HTS and the NS group, there were no significant changes in MI. (+Tacro HTS= pre = 644.9 ± 6.9, w1 = 661.6 ± 3.3, w2 = 650.3 ± 6.2, w3 = 636.3 ± 7.4) (−Tacro HTS= pre = 696.8 ± 8.0, w1 = 695.8 ± 12.3, w2 = 678.9 ± 14.0, w3 = 731.2 ± 50.3). LADD did not lead to any differential change in pigmentation compared to the non‐LADD group. There was no evidence of increased melanogenesis within the tissue punch biopsies at any timepoint. There were no changes in TYR, TYRP1, or DCT gene expression after treatment.
Conclusion
Hypopigmented HTSs treated with 0.1% tacrolimus ointment with or without LADD did not show significantly increased repigmentation. This study was limited by a shorter treatment interval than what is known to be required in vitiligo patients for repigmentation. The use of noninvasive, topical treatments to promote repigmentation are an appealing strategy to relieve morbidity associated with dyschromic burn scars and requires further investigation.
Pathological scars, including keloids and hypertrophic scars, are best managed by preventative strategies, such as occlusive silicone dressings or gels, or pressure therapies. For established lesions, intralesional corticosteroids, particularly triamcinolone acetonide (TAC) are first-line therapies. Combining TAC with intralesional 5-fluorouracil or non-pharmacological options such as lasers is generally more effective than monotherapy and may be better tolerated. Other treatments include cryotherapy, botulinum toxin type A, and more novel therapies including anti-cancer and anti-inflammatory agents. Well-designed clinical trials are needed to determine the optimal combinations and dosage regimens.
Background:
Burn damage to skin often results in scarring; however in some individuals the failure of normal wound-healing processes results in excessive scar tissue formation, termed 'hypertrophic scarring'. The most commonly used method for the prevention and treatment of hypertrophic scarring is pressure-garment therapy (PGT). PGT is considered standard care globally; however, there is continued uncertainty around its effectiveness.
Objectives:
To evaluate the benefits and harms of pressure-garment therapy for the prevention of hypertrophic scarring after burn injury.
Search methods:
We used standard, extensive Cochrane search methods. We searched CENTRAL, MEDLINE, Embase, two other databases, and two trials registers on 8 June 2023 with reference checking, citation searching, and contact with study authors to identify additional studies.
Selection criteria:
We included randomised controlled trials (RCTs) comparing PGT (alone or in combination with other scar-management therapies) with scar management therapies not including PGT, or comparing different PGT pressures or different types of PGT.
Data collection and analysis:
At least two review authors independently selected trials for inclusion using predetermined inclusion criteria, extracted data, and assessed risk of bias using the Cochrane RoB 1 tool. We assessed the certainty of evidence using GRADE.
Main results:
We included 15 studies in this review (1179 participants), 14 of which (1057 participants) presented useable data. The sample size of included studies ranged from 17 to 159 participants. Most studies included both adults and children. Eight studies compared a pressure garment (with or without another scar management therapy) with scar management therapy alone, five studies compared the same pressure garment at a higher pressure versus a lower pressure, and two studies compared two different types of pressure garments. Studies used a variety of pressure garments (e.g. in-house manufactured or a commercial brand). Types of scar management therapies included were lanolin massage, topical silicone gel, silicone sheet/dressing, and heparin sodium ointment. Meta-analysis was not possible as there was significant clinical and methodological heterogeneity between studies. Main outcome measures were scar improvement assessed using the Vancouver Scar Scale (VSS) or the Patient and Observer Scar Assessment Scale (POSAS) (or both), pain, pruritus, quality of life, adverse events, and adherence to therapy. Studies additionally reported a further 14 outcomes, mostly individual scar parameters, some of which contributed to global scores on the VSS or POSAS. The amount of evidence for each individual outcome was limited. Most studies had a short follow-up, which may have affected results as the full effect of any therapy on scar healing may not be seen until around 18 months. PGT versus no treatment/lanolin We included five studies (378 participants). The evidence is very uncertain on whether PGT improves scars as assessed by the VSS compared with no treatment/lanolin. The evidence is also very uncertain for pain, pruritus, adverse events, and adherence. No study used the POSAS or assessed quality of life. One additional study (122 participants) did not report useable data. PGT versus silicone We included three studies (359 participants). The evidence is very uncertain on the effect of PGT compared with silicone, as assessed by the VSS and POSAS. The evidence is also very uncertain for pain, pruritus, quality of life, adverse events, adherence, and other scar parameters. It is possible that silicone may result in fewer adverse events or better adherence compared with PGT but this was also based on very low-certainty evidence. PGT plus silicone versus no treatment/lanolin We included two studies (200 participants). The evidence is very uncertain on whether PGT plus silicone improves scars as assessed by the VSS compared with no treatment/lanolin. The evidence is also very uncertain for pain, pruritus, and adverse events. No study used the POSAS or assessed quality of life or adherence. PGT plus silicone versus silicone We included three studies (359 participants). The evidence is very uncertain on the effect of PGT plus silicone compared with silicone, as assessed by the VSS and POSAS. The evidence is also very uncertain for pain, pruritus, quality of life, adverse events, and adherence. PGT plus scar management therapy including silicone versus scar management therapy including silicone We included one study (88 participants). The evidence is very uncertain on the effect of PGT plus scar management therapy including silicone versus scar management therapy including silicone, as assessed by the VSS and POSAS. The evidence is also very uncertain for pain, pruritus, quality of life, adverse events, and adherence. High-pressure versus low-pressure garments We included five studies (262 participants). The evidence is very uncertain on the effect of high pressure versus low pressure PGT on adverse events and adherence. No study used the VSS or the POSAS or assessed pain, pruritus, or quality of life. Different types of PGT (Caroskin Tricot + an adhesive silicone gel sheet versus Gecko Nanoplast (silicone gel bandage)) We included one study (60 participants). The evidence is very uncertain on the effect of Caroskin Tricot versus Gecko Nanoplast on the POSAS, pain, pruritus, and adverse events. The study did not use the VSS or assess quality of life or adherence. Different types of pressure garments (Jobst versus Tubigrip) We included one study (110 participants). The evidence is very uncertain on the adherence to either Jobst or Tubigrip. This study did not report any other outcomes.
Authors' conclusions:
There is insufficient evidence to recommend using either PGT or an alternative for preventing hypertrophic scarring after burn injury. PGT is already commonly used in practice and it is possible that continuing to do so may provide some benefit to some people. However, until more evidence becomes available, it may be appropriate to allow patient preference to guide therapy.
There are four distinct but overlapping phases of wound healing: hemostasis (vasoconstriction, activation of platelets, formation of fibrin matrix), inflammation (release of mast cell mediators, modification of vascular permeability, passage of neutrophils to the site of injury), proliferation (fibroblast proliferation, neoangiogenesis), and remodeling (maturation of granulation tissue into a scar). Acute wounds progress through the healing phases in an orderly fashion for normal healing to occur. However, pathologic responses may occur. Hypopigmentation (scar lighter than normal tissue) and hyperpigmentation (scar darker than normal tissue) are healing anomalies of pigmentation. Hypertrophic scars and keloids are healing disturbances manifesting as excessive scarring. Treatment of hypertrophic scars depends on scar contracture severity. In less severe cases, conservative therapies (silicone gel sheeting, compression garments, intralesional injection of corticosteroids/5-fluorouracil, laser therapy) are indicated. In severe cases, surgery is the first choice. Keloid treatment depends on the number and size of the lesions. Small and single keloids may be treated by surgery with adjuvant therapy (e.g., radiotherapy) or multimodal conservative therapy. For large and multiple keloids, volume- and number-reducing surgery is a choice. Other scar problems are the stretched scar, crosshatching, malaligned scars, trapdoor scars, anatomical mismatch, unstable scars, and collagen defects. Specific problems related to the various anatomic areas of the face (scalp, eyebrows, eyelids, lacrimal system, nose, lips, and neck) are further highlighted.
Pressure therapy (PT) is an effective intervention for reducing scarring, but its underlying mechanism remains largely unclear. Here, we demonstrate that human scar-derived myofibroblasts dedifferentiate into normal fibroblasts in response to PT, and we identify how SMYD3/ITGBL1 contributes to the nuclear relay of mechanical signals. In clinical specimens, reductions in SMYD3 and ITGBL1 expression levels are strongly associated with the anti-scarring effects of PT. The integrin β1/ILK pathway is inhibited in scar-derived myofibroblasts upon PT, leading to decreased TCF-4 and subsequently to reductions in SMYD3 expression, which reduces the levels of H3K4 trimethylation (H3K4me3) and further suppresses ITGBL1 expression, resulting the dedifferentiation of myofibroblasts into fibroblasts. In animal models, blocking SMYD3 expression results in reductions of scarring, mimicking the positive effects of PT. Our results show that SMYD3 and ITGBL1 act as sensors and mediators of mechanical pressure to inhibit the progression of fibrogenesis and provide therapeutic targets for fibrotic diseases.
Scars form a medical problem still considered as a cosmetic issue by most of the societies and poorly covered except for burns and trauma. The classification established in 2002 (Mustoe et al. 2002) separates 6 classes of scars, from immature scar to large spreading keloidas. POSAS scale is now considered as one of the most valuable tool concerning objective assessment, taking in account the perception and the psychological consequences observed by the patient him(her)self and the surrounding actors. Amo ng the 30 Millions of surgical procedures realized every year in Europe, 1–6% lead to postoperative complications like surgical site infection, largely impacting the scar quality. The development of hypertrophic scars depends on the age, the anatomical location and its specific mechanical properties (the face is not submitted to the same mechanical forces than the back), the origin of the lesion (burns, post-op local infection,…) and the compliance of the patient to the proposed treatments. Scar management drastically changed during the last decade. Thanks to a large transdisciplinary approach, new technologies emerged. These technologies are mainly based on early mechanotherapy, antiproliferative drugs and lasers.KeywordsPathological scarringMechanotherapyLasersPrevention
Rehabilitation orientiert sich bei Zielsetzung, Auswahl der Therapiemethoden und Dauer an erreichbarer Teilhabe, die durch Selbstversorgung, Mobilität, soziale Integration sowie psychoemotionale Stabilität gekennzeichnet ist. Rehabilitation ist so lange gerechtfertigt, wie verbesserte Funktion oder Kompensation eine verbesserte Gestaltung individueller Lebensbereiche und Lebenssituationen ermöglicht. Dies setzt ein individualisiertes, standardisiertes und flexibles Therapiekonzept voraus. Traumaassoziierte psychoemotionale Störungen müssen zeitig erkannt und einem normierten Behandlungskonzept zugeführt werden. Je effizienter rehabilitative Versorgungsstrukturen genutzt werden, umso effektiver werden Gesamtprognose sowie individuelle, soziale und berufliche Reintegration beeinflusst.
Hypertrophic scars and keloids can have significant detrimental effects on patients both psychosocially and functionally. A careful identification of patient risk factors and a comprehensive management plan are necessary to optimize outcomes. Patients with a history of dystrophic scarring should avoid unnecessary procedures and enhance the wound-healing process using various preventive strategies. As there is no single, fully efficacious treatment modality, prevention remains the best approach in reducing aberrant scar formation. When prevention therapies fail, keloids have been shown to be respond to a variety of therapies including topical and injectable corticosteroids, 5-fluorouracil, radiotherapy, lasers, and surgical excision, all with varying efficacies. As such, management should be tailored to the individual patient's risk factors with the use of combination therapies to reduce recurrence rates. Still, keloid and hypertrophic scar therapies are widely diverse with novel treatment modalities providing alternatives for recurring lesions. Laser-assisted drug delivery, skin priming, and novel topical therapies may provide alternative options for the management of hypertrophic scars and keloids.
Keloid scars affect different populations, compromising patients’ quality of
life. The literature presents several treatments.The study aimed to conduct an
integrative review of systematic review articles and/or meta-analyses addressing
keloid treatment in the PubMed, LILACS, MEDLINE, and Cochrane databases from
2015 to 2021. After identification and following the selection and eligibility
criteria, 24 articles were included for qualitative review. We observed that the
diffculty in evaluating recurrence affected different keloids treatment
modalities, still presenting many failure rates and the need for further
studies.
Burns are one of the most devastating traumas and are the fourth most common type of trauma worldwide, following motor vehicle accidents, unintentional falls, and assault (injuries purposely afflicted) [1]. The World Health Organization estimates that in 2004 alone, nearly 11 million people worldwide required medical attention for burns [2]. They can be physically and psychologically devastating and can produce some of the most disfiguring scars seen in clinical practice and present unique challenges in terms of treatment. Fortunately, survival and mortality rates have improved substantially as a direct result of medical advancements. Advances in the critical care of massive burn injuries pushed the lethal dosage 50 for burns based on affected TBSA to approximately 90% [3]. As the consequence of this increased survival rate, the number of people with severe burn scars increased during recent years. In addition to serving as visible reminders of the burn injury and compromising self-esteem and self-image, burn scars produce considerable problems for the survivor. Despite assiduous efforts in traditional scar management, severe scars often persist to significantly diminish quality of life by disfigurement, pain, itchiness, and contractures restraining the motion of the body and joints [4]. Researches [5, 6] have shown that up to 77% of burn injuries develop pathological scarring. Of the patients, more than 40% suffer from hypertrophic scarring and one third from hypertrophic scarring and contractures; contractures alone are present in 5% of patients with burns [5]. While scar hypertrophy often improves within 2 years after trauma [7], disturbing scar features often persist and result in prolonged and intense patient suffering. Contractures can often cause debilitating functional disabilities resulting in significantly decreased quality of life when left untreated. Burn scars in exposed areas, like the face, will often result in significantly decreased quality of life through problems like microstomia and ectropion as well as the immensely defacing impact on facial esthetics [8–12]. The stigmata of burn scars are plainly visible, but the injury to the patient is usually more than “skin deep,” and with improvements in the management of burn patients and the herewith associated improved survival rates, these scars can create significant morbidity. Patients, besides the obvious stigma, can present severe pruritus, neuropathic pain, and contractures [13–17], which may have harmful physical, aesthetic, and social consequences associated with substantial financial costs for modern health-care systems. There are two main problems with the scars: appearance and function. These problems can imply seemingly paradoxical situations. Usually huge scars around big joints affect the range of motion, but, sometimes, large unsightly scars may not impact on the function of the body. Small scars are usually negligible, but if positioned in important areas (e.g., eyes, mouth, neck), also small barely noticeable scars can impair function and cosmetic appearance considerably. Many nonsurgical approaches and options have been suggested and implemented into the daily practice to improve scar management. Recent and current guidelines [18, 19] for the treatment of pathological scarring state that silicone gel preparations should be used as a first-line therapy. Pressure garments, which are traditionally recommended as a first-line therapy in guidelines specific to burn injury treatment [20], as well as onion extract-based products may be advisable too, even though data on their efficacy is not as robust [18, 19]. Surgery still remains the principal method to improve contracted scars [21, 22]. Local tissue (Z-plasty, Y-to-V flaps, local flaps, and skin expanders) as well as distant tissue (split-thickness skin grafts, full thickness skin grafts, or free tissue transfer) can be used to release the tension through a scar ultimately improving the range of motion of affected areas. Surgery is usually very effective, but it is associated with considerable morbidity and high recurrence rate, and often the efficacy is limited to the surgical site [22].
Background
Following burn injury and a prolonged duration of healing, scars may become hypertrophic, causing movement restriction, increased scar thickness, colour and pliability, and symptoms such as pain and itch. Acupuncture has emerged as a potentially beneficial treatment for neuroinflammation, which perpetuates the negative features of hypertrophic scars. The aim of this study was to pilot test an evidence-based methodology for applying and measuring the clinical effects of localised acupuncture for symptomatic scars, in a patient with a healed burn injury.
Methods
A 71-year-old caucasian male presented with a hypertrophic scar that was painful and itchy after burn injury and subsequent skin grafting. He received acupuncture and massage treatment local to his scar as per the local (verum) group of the author's clinical trial under recruitment. Needles were inserted around the circumference of the skin grafted area and adjacent to areas of raised scar tissue within the grafted area and stimulated via bi-directional rotation. Outcome measures included a Numerical Rating Scale (NRS) for pain and itch, Patient and Observer Scar Assessment Scale (POSAS) self-assessment component and SF36 quality-of-life measure to capture any non-specific acupuncture effects.
Conclusion
Acupuncture applied locally around the scar was associated with short-term relief of symptoms and significantly reduced his subjective outcome measure scores relating to scar thickness, redness and pliability out to six months after injury. Some short-term increase in symptoms occurred on several occasions following treatment; however, treatment was well tolerated supporting the use of this protocol for a larger future clinical trial.
Lay Summary
Following injury to the skin, scars can become raised, red and reduce movement. Other common symptoms may include pain and itch. Previous studies suggest acupuncture may help symptomatic scars, but more research is needed to confirm this with larger samples of patients. This case study tested the active treatment protocol for a clinical trial using acupuncture on symptomatic scars. A 71-year-old white man had a burn scar on his torso after a workplace accident. His treatment involved scar massage and local acupuncture. The acupuncture needles were inserted around the skin graft borders and thickened bands of scar tissue. Outcomes were measured using surveys recording symptoms, scar characteristics and quality of life. These were used to assess treatment effect and how well the protocol was tolerated. Over the course of treatment both pain and itch improved This case report showed that the treatment protocol was well tolerated, and that local acupuncture was associated with improved scar symptoms and physical characteristics up to six months after injury.
Riassunto
Le cicatrici ipertrofiche e i cheloidi corrispondono a una disregolazione della cicatrizzazione cutanea. Il loro trattamento si rende necessario a fronte dell’esistenza di disagi e segni funzionali invalidanti e, il più delle volte, della loro natura antiestetica. Le recidive quasi costanti dopo exeresi chirurgica e la moltitudine di metodiche utilizzate, di varia efficacia, sono un corollario delle difficoltà terapeutiche. Diversi trattamenti hanno mostrato buoni risultati in piccoli studi, senza alcun vero studio comparativo o con follow-up a lungo termine. Massaggi cicatriziali, pressoterapia, crioterapia, applicazioni di gel di silicone, laser, iniezioni intralesionali (principalmente corticosteroidi, bleomicina e 5-fluorouracile), radioterapia e così via sono utilizzati da soli o il più delle volte in associazione, consentendo una riparazione progressiva della cicatrice. Questo articolo presenta una revisione critica dei diversi trattamenti basata sull’analisi della letteratura e sull’esperienza degli autori nella gestione delle cicatrici ipertrofiche e dei cheloidi.
Keloids are fibroproliferative disorders that can result from cutaneous injuries to the reticular dermis. Recurrence rates as high as 100% have been reported following surgical excision alone. Consequently, a variety of post-surgical techniques have been employed to prevent keloid recurrence, including the use of radiation. Although numerous studies have shown that post-excisional X-rays, electron beams, lasers, and brachytherapy can reduce the rate of keloid recurrence, numerous inconsistencies, including a wide range of definitions for keloid recurrence, render it difficult to compare the outcomes. The treatment of severe keloids in children is much more challenging, and there have been few previous reports. It is generally believed that children with keloids should be treated with non-surgical treatment such as hormone injections and radiotherapy. For severe keloids, these methods require a long treatment period, and their efficacy is not ideal. Moreover, the side effects of the treatment can affect children’s health. If keloid scars are not effectively treated, they will often seriously affect the physical and mental health of children. The purpose of this review is to discuss case studies of children with severe keloids who were only treated with surgery and their postoperative recovery. In this case, the deep-embedded circular mattress suture technique (LBD, the looped, broad, and deep buried suturing technique) was used in the scar resection. After 18 months of follow-up, the surgical scar was evaluated using the Vancouver Scar Scale (VSS). The scar was stable and did not recur. The child was satisfied. This case shows that it is completely feasible to treat severe keloids with surgery alone, as long as the tension is reduced during the operation to prevent surgical scar hyperplasia.
Introduction
With limited resources for rehabilitation, burn therapists throughout the world rely on local resources, professional creativity and community relationships to create solutions to help their patients recover. The demands of helping a burn survivor achieve an optimal outcome drive the burn therapist to create tools and strategies that effectively solve common problems after burn injury.
Methods
The International Society for Burn Injury (ISBI) invited burn therapists from around the world to describe the innovations that they have created to solve burn rehabilitation problems. The submissions were provided through an online form and inclusion of photographs was encouraged. Each submission was reviewed in a blinded manner by an expert panel of three independent rehabilitation therapists from the ISBI Rehabilitation Committee. The submissions were reviewed for originality, utility, quality and safety, then edited and compiled to be shared and disseminated throughout the world.
Results
A total of 77 innovations were submitted for review. 71 were accepted for publication (92%) and given the opportunity to publish in Burns Open. Clinicians from 15 countries submitted innovations. The innovations were categorized as: Orthosis, Scar Management, Techniques, Activities of Daily Living Devices, Educational Tools and Prosthesis. Nineteen submissions were translated from Spanish to English.
Discussion
Creative and innovative ideas using local resources are turned into patient solutions by experienced burn therapists around the world. However, because such innovations don’t reach widespread investigation or production, the ideas remain in a silo in the local area when they could be of use to therapists in other cultures. This project resulted in a book of “Innovative Solutions in Burn Rehabilitation from Around the World,” that was printed and is now available as this Special Edition in Burns Open. Future work would include expanding on the book with more innovative solutions and translating it into multiple languages to improve access and usability throughout the world.
Introduction
With limited resources for rehabilitation, burn therapists throughout the world rely on local resources, professional creativity and community relationships to create solutions to help their patients recover. The demands of helping a burn survivor achieve an optimal outcome drive the burn therapist to create tools and strategies that effectively solve common problems after burn injury.
Methods
The International Society for Burn Injury (ISBI) invited burn therapists from around the world to describe the innovations that they have created to solve burn rehabilitation problems. The submissions were provided through an online form and inclusion of photographs was encouraged. Each submission was reviewed in a blinded manner by an expert panel of three independent rehabilitation therapists from the ISBI Rehabilitation Committee. The submissions were reviewed for originality, utility, quality and safety, then edited and compiled to be shared and disseminated throughout the world.
Results
A total of 77 innovations were submitted for review. 71 were accepted for publication (92%) and given the opportunity to publish in Burns Open. Clinicians from 15 countries submitted innovations. The innovations were categorized as: Orthosis, Scar Management, Techniques, Activities of Daily Living Devices, Educational Tools and Prosthesis. Nineteen submissions were translated from Spanish to English.
Discussion
Creative and innovative ideas using local resources are turned into patient solutions by experienced burn therapists around the world. However, because such innovations don’t reach widespread investigation or production, the ideas remain in a silo in the local area when they could be of use to therapists in other cultures. This project resulted in a book of “Innovative Solutions in Burn Rehabilitation from Around the World,” that was printed and is now available as this Special Edition in Burns Open. Future work would include expanding on the book with more innovative solutions and translating it into multiple languages to improve access and usability throughout the world.
Pressure garments are used to treat scars after major trauma including burns. However, the ideal pressure for treatment is not known. Pressures exerted are not routinely measured and garments exert a wide range of pressures. Therefore, current treatment and its efficacy are variable.
Pressure Garment Design Tools were introduced in 2012 but their application in hospitals has not been reported. A Garment Dimension and Pressure Calculator was used to audit pressures delivered by 8 pressure garments made for children using the hospital department’s standard reduction factor. The tool was easy to use and showed that pressures exerted by standard garments ranged from 15 to 54 mmHg with highest pressures exerted on wrists.
Results of our pilot study indicated that the Garment Dimension and Pressure Calculator was slightly quicker to use than our normal manual process for calculating garment dimensions and enabled easy auditing of past treatment. The Pressure Garment Design Tool was easy to use and calculated garments that exerted the mean target pressures of 15 mmHg and 25 mmHg, improving consistency.
Pressures exerted by garments were difficult and time consuming to measure with the Picopress sensor. Pressure was not distributed evenly around the limbs and measurements were inaccurate on the smallest limbs.
Background
Pressure Garment Treatment (PGT) is currently recognized as an effective method to prevent scar formation or treat scar hyperplasia. Research on PGT remains controversial. These controversies indicate that PGT lacks reliable evidence of evidence-based medicine. Different studies on PGT need to be conducted under the same ‘gold standard’ so that different studies can be compared. We consider this ‘gold standard’ to be that the pressure remains stable within a confidence interval during treatment.
Methods
We calibrated and verified the reference value of the sensor using a cuff of sphygmanometer.A pressure adjustable pressure system was obtained by installing a soft tissue expander on the pressure garment.Local pressure was adjusted by charging and releasing air.Subsequently, the flexible pressure sensor was placed on the upper arm of the healthy volunteers. We validated the compression system on healthy volunteers' forearms and AO standard prostheses (forearms).
Results
Reference value of the sensor was calibrated on No.1 volunteer. Measuring repeated on No.2 and No. 3. The measurement was very reproducible. The test results in the experimental group showed that the local pressure gradually increased with the increase of the inflation of the airbag. However, the pressure at the opposite position of the forearm changed little.
Conclusions
Real-time pressure monitoring and pressure adjustment enable the pressure to be maintained at a certain value. Our study provides a new idea for the production of elastic clothing with the function of pressure measurement and pressure regulation, which may promote the accuracy and reliability of PGT.
Objective
Cesarean section (CS) is a major surgical intervention that affects women at childbearing age. Scarring from CS potentially causes discomfort and psychological distress. Emerging evidence indicates that epidermal growth factor (EGF) plays crucial roles in wound healing with the potential of minimizing scar formation. This study aims to investigate the effect of microencapsulated recombinant human EGF (Me-EGF) in scar prevention. Silicone gel was incorporated as part of the routine scar treatment.
Materials and methods
Healthy women scheduled for cesarean delivery were enrolled and randomized to three groups: (1) no scar treatment, (2) silicone gel only, or (3) silicone gel plus Me-EGF. Vancouver Scar Scale (VSS: vascularity, pigmentation, elasticity, and height) was used for scar assessment at the 6th month and 9th month after CS.
Results
A total of 60 women were enrolled, but one patient withdrew due to noncompliance with the follow-up visit requirement. Me-EGF-containing treatment group consistently scored the lowest on every parameter in the VSS scale, followed by silicone gel group, and the group with no scar treatment. Kruskal–Wallis tests indicated significant differences (p < 0.05) between Me-EGF-containing treatment group and the other two groups in vascularity, pigmentation, elasticity, and the VSS total score, at either 6th month, 9th month, or both time points. The only parameter not showing any significant between-group difference was scar height, but the pattern still remained the same, in which Me-EGF group scored better in both month 6 and 9.
Conclusion
Surgical incisions in lower abdomen posed challenge in scar management. Our findings suggest that Me-EGF is a potential therapeutic option for better wound healing and scar prevention.
CLINICAL SCENARIO
You are a general internist who is asked to see a 65-year-old man with controlled hypertension and a 6-month history of atrial fibrillation resistant to cardioversion. Although he has no evidence for valvular or coronary heart disease, the family physician who referred him to you wants your advice on whether the benefits of long-term anticoagulants (to reduce the risk of embolic stroke) outweigh their risks (of hemorrhage from anticoagulant therapy). The patient shares these concerns and doesn't want to receive a treatment that would do more harm than good. You know that there have been randomized trials of warfarin for nonvalvular atrial fibrillation and decide that you'd better review one of them.
To examine the sensitivity and precision of Medline searching for randomised clinical trials.
Comparison of results of Medline searches to a "gold standard" of known randomised clinical trials in ophthalmology published in 1988; systematic review (meta-analysis) of results of similar, but separate, studies from many fields of medicine.
Randomised clinical trials published in 1988 in journals indexed in Medline, and those not indexed in Medline and identified by hand search, comprised the gold standard. Gold standards for the other studies combined in the meta-analysis were based on: randomised clinical trials published in any journal, whether indexed in Medline or not; those published in any journal indexed in Medline; or those published in a selected group of journals indexed in Medline.
Sensitivity (proportion of the total number of known randomised clinical trials identified by the search) and precision (proportion of publications retrieved by Medline that were actually randomised clinical trials) were calculated for each study and combined to obtain weighted means. Searches producing the "best" sensitivity were used for sensitivity and precision estimates when multiple searches were performed.
The sensitivity of searching for ophthalmology randomised clinical trials published in 1988 was 82%, when the gold standard was for any journal, 87% for any journal indexed in Medline, and 88% for selected journals indexed in Medline. Weighted means for sensitivity across all studies were 51%, 77%, and 63%, respectively. The weighted mean for precision was 8% (median 32.5%). Most searchers seemed not to use freetext subject terms and truncation of those terms.
Although the indexing terms available for searching Medline for randomised clinical trials have improved, sensitivity still remains unsatisfactory. A mechanism is needed to "'register" known trials, preferably by retrospective tagging of Medline entries, and incorporating trials published before 1966 and in journals not indexed by Medline into the system.
It has been suggested that the quality of clinical trials should be assessed by blinded raters to limit the risk of introducing bias into meta-analyses and systematic reviews, and into the peer-review process. There is very little evidence in the literature to substantiate this. This study describes the development of an instrument to assess the quality of reports of randomized clinical trials (RCTs) in pain research and its use to determine the effect of rater blinding on the assessments of quality. A multidisciplinary panel of six judges produced an initial version of the instrument. Fourteen raters from three different backgrounds assessed the quality of 36 research reports in pain research, selected from three different samples. Seven were allocated randomly to perform the assessments under blind conditions. The final version of the instrument included three items. These items were scored consistently by all the raters regardless of background and could discriminate between reports from the different samples. Blind assessments produced significantly lower and more consistent scores than open assessments. The implications of this finding for systematic reviews, meta-analytic research and the peer-review process are discussed.
Identifying relevant studies is “the most fundamental challenge” when compiling a systematic review.1 Electronic databases, such as Medline, may detect only about half of papers identified by the gold standard of hand searching journals.1 Hand searching requires a focus, usually the specialist literature,2 which may not exist for newly developed fields or those that cross boundaries with other areas. We examined the usefulness of contacting other experts when searching for relevant references for a systematic review of a field where such a specialist focus does not exist.
View this table:
Results of various types of search
As part of a systematic review undertaken in 1996, all published literature relating to “near patient testing” (any investigation performed in a clinical setting where the result is available without a sample being sent to a laboratory for analysis) in primary care was identified for 1986-95.3 Electronic databases were searched and secondary citations were collected from identified publications (see table). The search strategy is reported elsewhere.3 Indexes of abstracts from major international …
Cochrane Reviews have recently started including the quantity I 2 to help readers assess the consistency of the results of studies in meta-analyses. What does this new quantity mean, and why is assessment of heterogeneity so important to clinical practice?
Systematic reviews and meta-analyses can provide convincing and reliable evidence relevant to many aspects of medicine and health care.1 Their value is especially clear when the results of the studies they include show clinically important effects of similar magnitude. However, the conclusions are less clear when the included studies have differing results. In an attempt to establish whether studies are consistent, reports of meta-analyses commonly present a statistical test of heterogeneity. The test seeks to determine whether there are genuine differences underlying the results of the studies (heterogeneity), or whether the variation in findings is compatible with chance alone (homogeneity). However, the test is susceptible to the number of trials included in the meta-analysis. We have developed a new quantity, I 2, which we believe gives a better measure of the consistency between trials in a meta-analysis.
Assessment of the consistency of effects across studies is an essential part of meta-analysis. Unless we know how consistent the results of studies are, we cannot determine the generalisability of the findings of the meta-analysis. Indeed, several hierarchical systems for grading evidence state that the results of studies must be consistent or homogeneous to obtain the highest grading.2–4
Tests for heterogeneity are commonly used to decide on methods for combining studies and for concluding consistency or inconsistency of findings.5 6 But what does the test achieve in practice, and how should the resulting P values be interpreted?
A test for heterogeneity examines the null hypothesis that all studies are evaluating the same effect. The usual test statistic …
Using an integrated, "team" approach, leading authority David N. Herndon, MD, FACS explains how to meet the clinical, physical, psychological, and social needs of every burn patient - and thus achieve optimal recovery and rehabilitation. The 3rd Edition of this definitive reference covers all of the latest advances in the treatment of burns...features new a full-color layout with new color illustrations and clinical photographs. Compiled and edited by one of the world's leading authorities on the management of patients with burns. Discusses the management of burn patients from their initial presentation through long-term rehabilitation. Addresses the clinical, physical, and social needs of the burn patient and emphasizes a multi-faceted, "team approach" to treatment. Covers how to devise integrated treatment programs for different groups of patients, such as elderly and pediatric patients. Uses color illustrations and clinical photographs throughout for the first time-incorporating the illustrative strengths of Barret & Herndon's Color Atlas of Burn Care to provide you with a single source of definitive guidance on diagnosis and management. Presents new chapters on barotrauma and inhalation injury · the tissue bank · the role of exercise · and the use of dermal templates and burn scar resurfacing. Offers fresh perspectives from more than 50% new authors. With more than 100 additional contributing experts.
Objective. —To determine if inadequate approaches to randomized controlled trial design and execution are associated with evidence of bias in estimating treatment effects. Design. —An observational study in which we assessed the methodological quality of 250 controlled trials from 33 meta-analyses and then analyzed, using multiple logistic regression models, the associations between those assessments and estimated treatment effects. Data Sources. —Meta-analyses from the Cochrane Pregnancy and Childbirth Database. Main Outcome Measures. —The associations between estimates of treatment effects and inadequate allocation concealment, exclusions after randomization, and lack of double-blinding. Results. —Compared with trials in which authors reported adequately concealed treatment allocation, trials in which concealment was either inadequate or unclear (did not report or incompletely reported a concealment approach) yielded larger estimates of treatment effects ( P P =.01), with odds ratios being exaggerated by 17%. Conclusions. —This study provides empirical evidence that inadequate methodological approaches in controlled trials, particularly those representing poor allocation concealment, are associated with bias. Readers of trial reports should be wary of these pitfalls, and investigators must improve their design, execution, and reporting of trials. ( JAMA . 1995;273:408-412)
Objectives.
—To estimate the rate of full publication of the results of randomized clinical trials initially presented as abstracts at national ophthalmology meetings in 1988 and 1989; and to combine data from this study with data from similar studies to determine the rate at which abstracts are subsequently published in full and the association between selected study characteristics and full publication.
Data Sources.
—Ophthalmology abstracts were identified by review of 1988 and 1989 meeting abstracts for the Association for Research in Vision and Ophthalmology and the American Academy of Ophthalmology. Similar studies were identified either from reports contained in our files or through a MEDLINE search, which combined the textword "abstract" with "or" statements to the Medical Subject Headings ABSTRACTING & INDEXING, CLINICAL TRIALS, PEER REVIEW, PERIODICALS, MEDICAL SOCIETIES, PUBLISHING, MEDLINE, INFORMATION SERVICES, and REGISTRIES.
Study Selection.
—Ophthalmolgy abstracts were selected from the meeting proceedings if they reported results from a randomized controlled trial. For the summary study, similar studies were eligible for inclusion if they described followup and subsequent full publication for a cohort of abstracts describing the results of any type of research study. All studies had to have followed up abstracts for at least 24 months to be included.
Data Extraction.
—Authors of ophthalmology abstracts were contacted by letter to ascertain whether there was subsequent full publication. Other information, including characteristics of the study design possibly related to publication, was taken from the abstract. For the summary study, rates of full publication were taken directly from reported results, as were associations between study factors (ie, "significant' results and sample size) and full publication.
Data Synthesis.
—Sixty-six percent (61/93) of ophthalmology abstracts were published in full. Combined results from 11 studies showed that 51% (1198/2391) of all abstracts were subsequently published in full. Full publication was weakly associated with "significant" results and sample size above the median.
Conclusions.
—Approximately one half of all studies initially presented in abstract form are subsequently published as full-length reports. Most are published in full within 2 years of appearance as abstracts. Full publication may be associated with "significant" results and sample size.(JAMA. 1994;272:158-162)
Guyatt G, Rennie D. Users’ Guides to the Medical Literature: A Manual for Evidence-Based Clinical Practice. Chicago: American Medical Association, 2001.
Since its introduction in JAMA in 1993, the Users’ Guides to the Medical Literature article series has become the standard for understanding and using the medical literature in daily practice. This series of 25 articles clarifies the principles of evidence-based medicine, and provides clear and practical guides for accessing and evaluating articles published in the medical literature. Users’ Guides to the Medical Literature: A Manual for Evidence-Based Clinical Practice is not only a compilation of the users’ guides from the JAMA series; it also modifies, expands, and updates the original articles.
Rennie’s insightful analogy in the foreword of the book states that the medical literature is “clearly visible but utterly inaccessible”, a message that serves as an honest appraisal of the difficulties faced by clinicians who are attempting to go …
The second edition of this best-selling book has been thoroughly revised and expanded to reflect the significant changes and advances made in systematic reviewing. New features include discussion on the rationale, meta-analyses of prognostic and diagnostic studies and software, and the use of systematic reviews in practice.
Preterm infants have a qualitative and quantitative deficiency of red cells. Thus, they may have difficulty in meeting their often high oxygen needs. It is vital therefore to develop a strategy for optimization of their blood for oxygen transport. The ability of the blood both to carry oxygen and to perfuse the whole circulation, are the vital hematologic variables in oxygen delivery. Inadequacy in both of these functions is the rule in most preterm infants during intensive management. Hemoglobin concentration/hematocrit values are incomplete guides to these deficiencies. Circulating blood volume must also be taken into account. A strategy is outlined to allow optimization of the blood ab initio by appropriate placento-fetal transfusion at birth. Maintenance of hemoglobin concentration for oxygen transport later in an infant's clinical course may become possible using recombinant human erythropoietin. Meanwhile, when donor red cell transfusion is needed, the “dose” should reflect and aim to correct the deficiency in circulating red cell mass.
Clinicians can often find treatment recommendations in
traditional narrative reviews and the discussion sections of original
articles and meta-analyses. Making a treatment recommendation involves
framing a question, identifying management options and outcomes,
collecting and summarizing evidence, and applying value judgments or
preferences to arrive at an optimal course of action. Each step in this
process can be conducted systematically (thus protecting against bias)
or unsystematically (leaving the process open to bias). Clinicians
faced with a plethora of recommendations may wish to attend to those
that are less likely to be biased. Therefore, we propose a hierarchy of
rigor of recommendations to guide clinicians when judging the
usefulness of particular recommendations. Recommendations with the
highest rigor consider all relevant options and outcomes, include a
comprehensive collection of the methodologically highest quality data
with an explicit strategy for summarizing the data (that is, a
systematic review), and make an explicit statement of the values or
preferences involved in moving from evidence to action. High rigor
recommendations come from systematically developed, evidence-based
practice guidelines or rigorously conducted decision analyses.
Systematic reviews, which typically do not consider all relevant
options and outcomes or make the preferences underlying recommendations
explicit, offer intermediate rigor recommendations. Traditional
approaches in which the collection and assessment of evidence remains
unsystematic, all relevant options and outcomes may not be considered,
and values remain implicit, provide recommendations of weak rigor. In
an era in which clinicians are barraged by recommendations as to how to
manage their patients, this hierarchy provides a potentially useful set
of guides.
Objective.
—To determine if inadequate approaches to randomized controlled trial design and execution are associated with evidence of bias in estimating treatment effects.Design.
—An observational study in which we assessed the methodological quality of 250 controlled trials from 33 meta-analyses and then analyzed, using multiple logistic regression models, the associations between those assessments and estimated treatment effects.Data Sources.
—Meta-analyses from the Cochrane Pregnancy and Childbirth Database.Main Outcome Measures.
—The associations between estimates of treatment effects and inadequate allocation concealment, exclusions after randomization, and lack of double-blinding.Results.
—Compared with trials in which authors reported adequately concealed treatment allocation, trials in which concealment was either inadequate or unclear (did not report or incompletely reported a concealment approach) yielded larger estimates of treatment effects (P<.001). Odds ratios were exaggerated by 41% for inadequately concealed trials and by 30% for unclearly concealed trials (adjusted for other aspects of quality). Trials in which participants had been excluded after randomization did not yield larger estimates of effects, but that lack of association may be due to incomplete reporting. Trials that were not double-blind also yielded larger estimates of effects (P=.01), with odds ratios being exaggerated by 17%.Conclusions.
—This study provides empirical evidence that inadequate methodological approaches in controlled trials, particularly those representing poor allocation concealment, are associated with bias. Readers of trial reports should be wary of these pitfalls, and investigators must improve their design, execution, and reporting of trials.(JAMA. 1995;273:408-412)
With the recent advances in burns treatment, many more survive the burn to experience pain, scarring, physical deformity, loss of function and psychological trauma. Pressure therapy prescribed by occupational therapists for more than 20 years in Hong Kong has proved its effectiveness in treating the visible scars. However, the inconvenience and impaired appearance that is brought about by these garments during the long phase of therapy bears some weight in worsening patients' social acceptance and happiness in life, also their families especially in children. The objects of the studies were to measure the subjective rating of the effectiveness of pressure therapy through patients' satisfaction towards treatment effectiveness and its effect on daily life. Seventy cases with burn injuries over 1 year previously were selected randomly among the centres for the survey. The scale used was ordinal from 1 to 6. Eleven items concerning treatment effectiveness, life at home, work and leisure aspects were questioned. Results were analysed into two streams — satisfaction towards pressure therapy and change of life satisfaction pre- and post-injury. Non-parametric tests were used for data analysis. Through the Wilcoxon Sign Rank Test and Cluster analysis, major determinants were identified. These factors also showed significant correlation with this demographic data. The conclusions helped to evaluate and improve the existing service in both the garment properties and our scope of therapy for these patients, especially in work rehabilitation and finally (sexual) counselling which should be addressed by a team with interdepartmental support.
It has been suggested that deep partial-thickness burns of the hand which remain unhealed by 14 days should be excised and totally resurfaced. Controlled data supporting this suggestion is not available. Therefore, a prospective randomized study was performed on 222 burns of the hand to evaluate if excision and skin grafting had any advantage over conservative management. Full-thickness burns were eliminated from the series by excision and grafting them as soon as possible after the diagnosis had been made. To eliminate the very superficial burns, randomization did not take place until the wound had remained unhealed for ten days and would not heal for at least another week. In the two groups, the first ten days were managed similarly with topical antibacterials, escharotomies when necessary, and splinting in the "safe" position. Conservatively managed hands were treated with scarlet red gauze dressing as soon as all eschar had been removed. Those cases randomized into the excision and grafting group were operated upon approximately day 14. Physical therapy was the same in both groups except for the immediate period after grafting. Results were recorded by active and passive joint measurements and photographs on predetermined days throughout the study. In this study, spontaneous healing, taking as much as five weeks, gave acceptable results, comparable to excision and grafting performed at two weeks. The use of range of motion exercises, accurate splinting and pressure allowed optimal healing and prevented stiffness and contractures in both groups. There was no significant difference between the two treatment modalities.
Devastating functional problems can result from the formation of hypertrophic scar tissue after burn injury. Although a patient with burns may have several medical problems to contend with because of the injury, most ongoing rehabilitation difficulties are a consequence of the continual wound contraction that occurs in immature burn scars. Treatment of hypertrophic burn scar consists of several surgical options and of pressure therapy, which traditionally involves wearing garments made from elasticized fabric. This article reviews the treatment of hypertrophic scar tissue, with emphasis on its history and on nonsurgical methods of managing the burn scar.
A preliminary report of the results of pressure therapy for hypertrophic scar, burn contracture and keloid is presented. Thirty four patients over a four year period were treated with four types of pressure therapy. Results showed over 50% improvement in 21 (61.8%) cases. This method obviated the need for repetitive surgery and no recurrence was noted. Pressure therapy is advocated as an adjunct measure for all cases of hypertrophic scarring, burn contracture and keloid.
A prospective randomized study was undertaken to compare compliance efficacy and cost of the elastic nylon pressure garment (Jobst Institute, Inc., Toledo, Ohio) with the cotton elastic pressure garment (Tubigrip, SePro Healthcare Inc., Montgomeryville, Penn.). Of 110 patients enrolled, 54 received Jobst pressure garments and 56 received Tubigrip pressure garments. Time spent in pressure-therapy garments was the same for both groups. Comparable clinical results were achieved with either Tubigrip or Jobst garments. A significantly greater percentage of patients were compliant with Tubigrip pressure-garment therapy than with Jobst pressure-garment therapy. The cost of the Tubigrip garments was significantly lower than that of Jobst garments. These data suggest that the use of elasticized cotton pressure garments results in significantly better patient compliance, a lower cost, and equal therapeutic efficacy when compared with the elasticized nylon pressure garments.
A prospective study of 70 consecutive burned patients, 26 pediatric patients and 44 adults, who had 173 separate anatomic sites grafted, was carried out to determine the incidence of hypertrophic skin grafts after thermal injury. The age, race, postburn day grafted, anatomic site grafted, and nature of the recipient graft bed was recorded. The patients were followed for a minimum of 1 year, at which time the skin grafts were classified as Excellent (E)--skin graft flat and not thickened; Good (G)--less than 5% of skin graft thickened or elevated; Fair (F)--greater than 5% of skin graft thickened or elevated; and Poor (P)--skin graft elevated greater than 2 mm or contracture present. Overall, 55% of the grafted sites were excellent, 18% were good, 13% were fair, and 14% were poor. Pediatric patients had a higher incidence of fair or poor results (50%) than adults (17%) (p less than 0.001), and blacks had poorer (39% F or P) results than whites (12% F or P) (p less than 0.001). The presence of dermal elements in the recipient graft bed was associated with less long-term skin graft scarring than when the grafts were placed on recipient beds without dermal elements (p less than 0.01). Skin grafts that were performed within 14 days of the injury had a lower incidence of F or P results (24%), than grafts performed after 14 days postburn (37%) (p less than 0.03). Based on the results of this prospective study, it is possible to identify and quantitate the relative risk of a burned patient developing a hypertrophic skin graft.
Control of burn-scar hypertrophy remains a priority in the care of the burn patient. However, because of the problems associated with traditional compression therapy methods a study of the clinical utility of a tubular compressive bandage (TCB) was initiated. The clinical effectiveness of TCB was determined by studying 210 separate anatomic burn sites in 88 burn patients with a mean age of 25 years and a mean burn size of 21 per cent of the total body surface area (TBSA). To facilitate analysis of the results the patients were divided into two groups, the first group consisted of 71 patients who received prophylactic pressure therapy and a second group of 17 patients who received therapeutic pressure therapy after the establishment of hypertrophic scars. Mean follow-up of the entire group of patients was 11 months. The anatomic area involved by the burn was the most important factor in determining the effectiveness of TCB in this study. Failures primarily occurred at sites of mobility where pressure could not be consistently delivered or maintained, including the digits of the hand, axilla, groin and the head/neck regions. Overall, 85 per cent of the anatomic sites treated had good or satisfactory results. Based on the results of this study, we use TCB on all burn patients, who are at risk of developing burn-scar hypertrophy, immediately after the burn wound has healed or been surgically closed.
Pressure therapy is generally accepted as the best noninvasive means of preventing and controlling hypertrophic scarring after burn injury. Most studies in the past have failed to correlate clinical response with magnitude of the garment-scar interface pressure. This study looked critically at our usual techniques of pressure therapy using pressure 'sensors' manufactured locally and based on electro-pneumatic principles. Many pitfalls, such as large variations of pressure at different geometric sites on the body, elastic deterioration in garments, problems of garment manufacture, and the unfavourable properties of the Lycra garments, were observed. Recommendations on pressure treatment were made based on our experiences, to improve the present technique of pressure therapy. These included the standardization of measurement techniques and garment tailoring, the regular checking of pressure at the garment-scar interface using pressure transducers, the appropriate garment adjustments, a strict regimen for garment wearing, and the intelligent use of pressure-padding and reinforcement. Areas of further research are also discussed.
To determine if inadequate approaches to randomized controlled trial design and execution are associated with evidence of bias in estimating treatment effects.
An observational study in which we assessed the methodological quality of 250 controlled trials from 33 meta-analyses and then analyzed, using multiple logistic regression models, the associations between those assessments and estimated treatment effects.
Meta-analyses from the Cochrane Pregnancy and Childbirth Database.
The associations between estimates of treatment effects and inadequate allocation concealment, exclusions after randomization, and lack of double-blinding.
Compared with trials in which authors reported adequately concealed treatment allocation, trials in which concealment was either inadequate or unclear (did not report or incompletely reported a concealment approach) yielded larger estimates of treatment effects (P < .001). Odds ratios were exaggerated by 41% for inadequately concealed trials and by 30% for unclearly concealed trials (adjusted for other aspects of quality). Trials in which participants had been excluded after randomization did not yield larger estimates of effects, but that lack of association may be due to incomplete reporting. Trials that were not double-blind also yielded larger estimates of effects (P = .01), with odds ratios being exaggerated by 17%.
This study provides empirical evidence that inadequate methodological approaches in controlled trials, particularly those representing poor allocation concealment, are associated with bias. Readers of trial reports should be wary of these pitfalls, and investigators must improve their design, execution, and reporting of trials.
A prospective study was performed to determine whether patterns of burn scar maturation varied among different pediatric age groups. Patients were divided into three groups according to age at the time of burn injury: birth to 3 years, 4 to 11 years, and 12 to 18 years. Scarring of sheet grafts on an extremity was assessed throughout the maturation process in three areas: vascularity, pliability, and height. A 1-inch square was selected on the graft edge adjacent to unburned skin. Two experienced therapists independently evaluated the test area and averaged their scores. There were no significant differences in rate of scar maturation between age groups. Burn scar maturation of sheet skin grafts in the pediatric patient with burns demonstrated a rapid peak of scarring (1 to 2 months) and scar maturation (9 to 13 months).
To estimate the rate of full publication of the results of randomized clinical trials initially presented as abstracts at national ophthalmology meetings in 1988 and 1989; and to combine data from this study with data from similar studies to determine the rate at which abstracts are subsequently published in full and the association between selected study characteristics and full publication.
Ophthalmology abstracts were identified by review of 1988 and 1989 meeting abstracts for the Association for Research in Vision and Ophthalmology and the American Academy of Ophthalmology. Similar studies were identified either from reports contained in our files or through a MEDLINE search, which combined the textword "abstract" with "or" statements to the Medical Subject Headings ABSTRACTING & INDEXING, CLINICAL TRIALS, PEER REVIEW, PERIODICALS, MEDICAL SOCIETIES, PUBLISHING, MEDLINE, INFORMATION SERVICES, and REGISTRIES.
Ophthalmology abstracts were selected from the meeting proceedings if they reported results from a randomized controlled trial. For the summary study, similar studies were eligible for inclusion if they described followup and subsequent full publication for a cohort of abstracts describing the results of any type of research study. All studies had to have followed up abstracts for at least 24 months to be included.
Authors of ophthalmology abstracts were contacted by letter to ascertain whether there was subsequent full publication. Other information, including characteristics of the study design possibly related to publication, was taken from the abstract. For the summary study, rates of full publication were taken directly from reported results, as were associations between study factors (ie, "significant" results and sample size) and full publication.
Sixty-six percent (61/93) of ophthalmology abstracts were published in full. Combined results from 11 studies showed that 51% (1198/2391) of all abstracts were subsequently published in full. Full publication was weakly associated with "significant" results and sample size above the median.
Approximately one half of all studies initially presented in abstract form are subsequently published as full-length reports. Most are published in full within 2 years of appearance as abstracts. Full publication may be associated with "significant" results and sample size.
Pressure garment use is recommended 23 to 24 hours a day for hypertrophic scar control after a burn injury. Compliance with this treatment has not been documented. A 52-question survey was administered to 101 adult outpatient burn survivors to rate compliance with this program. The average compliance of each patient was assessed. The framework of the Health Belief Model was used to identify the patients' beliefs and factors reported to interfere with compliance. Strategies patients believed to enhance garment use were identified. Forty-one percent of the patients reported total compliance. The difficulties with garment use such as discomfort and activity limitations appeared to promote low compliance. The primary strategies patients believed would enhance compliance were seeing outcome pictures of scars and having contact with other survivors. This step toward identifying compliance rates and factors that affect them will guide the health care worker in techniques to facilitate adherence to the scar management program.
A randomized, prospective study was undertaken to determine the efficacy of pressure garment therapy in patients with burns. Patients were randomly assigned to receive either pressure garment therapy or no pressure garment therapy. Patients were observed by use of the Vancouver Burn Scar Assessment Scale to assess the maturity of all involved areas. One hundred and twenty-two consecutive patients were enrolled in the study; 64 were assigned to pressure garment therapy and 58 to no pressure garment therapy. Eight of the patients receiving pressure garment therapy and nine receiving no pressure garment therapy were not involved in the follow-up. No significant differences were found between the two groups when age, body surface area burn, length of hospital stay, or time to wound maturation were compared.
Lately, the number of systematic reviews published has increased substantially. Many systematic reviews exclude trials published in languages other than English. However, there is little empirical evidence to support this action. We looked for differences in the completeness of reporting between trials published in other languages and those published in English, to see whether the exclusion of trials published in other languages is justified.
We compared completeness of reporting, design characteristics, and analytical approaches of 133 randomised controlled trials (RCTs) published in English between 1989 and 1994 and 96 published in French, German, Italian, or Spanish during the same time. RCTs were identified by hand searching of journals (seven in English and six in the other languages).
We found no significant differences between trials published in English and other-language trials for any single item in the completeness of reporting scale (randomisation, double-blinding, withdrawals), or for the overall score (percentage of maximum possible score 51.0% for trials in English, 46.2% for trials in other languages; 95% CI for difference -1.1 to 10.5). Other-language trials were more likely than English-language trials to have adult participants, to use two or more interventions, and to compare two or more active treatments without an untreated control group. Trials in other languages were less likely to report a clearly prespecified primary outcome or any rationale for sample size estimation.
These results provide evidence for inclusion of all trial reports, irrespective of the language in which they are published, in systematic reviews. Their inclusion is likely to increase precision and may reduce systematic errors. We hope that our findings will prove useful to those developing guidelines and policies for the conduct of reporting of systematic reviews.
Pressure garments alter facial growth. We conducted a prospective study of facial growth in children wearing such garments to quantify these skeletal and dental disturbances. Three children with total face masks and three children with devices covering the lower face were studied. Panoramic and cephalometric radiographs were obtained at the start of treatment, approximately 6 months later, and at the end of the treatment. Clinical examinations were performed to document occlusal status and subsequent changes. Total face masks affected maxillary horizontal growth more than vertical growth. Mandibular growth changed from the normal anterior and inferior direction to a more inferior direction. With partial face masks, the most notable change was increased proclination of anterior teeth. Facial growth and the position of anterior teeth appear to be affected by the combination of the extent of the burn and skin graft and the type of pressure garments worn during the time of rehabilitation.
The subjective assessment of scar appearance is a widely used method in the evaluation of burn outcomes and the efficacy of treatment methods. The purpose of this study is to design a numeric scar-rating scale with better interrater reliability than has previously been reported. The rating scale assesses scar surface, thickness, border height, and color differences between a scar and the adjacent normal skin. Eight raters were trained with use of a standardized set of photographs that provide examples of the scores to be assigned to each level of severity of each scar characteristic. The raters then rated 10 photographs of different scars, referring to the teaching set of pictures for comparison. The intraclass correlation (interrater reliability) was 0.94, 0.95, 0.90, and 0.85 for scar surface, border height, thickness, and color, respectively. This rating system has proved to be a useful tool for the evaluation of scar surface, thickness, border height, and color.
Few meta-analyses of randomised trials assess the quality of the studies included. Yet there is increasing evidence that trial quality can affect estimates of intervention efficacy. We investigated whether different methods of quality assessment provide different estimates of intervention efficacy evaluated in randomised controlled trials (RCTs).
We randomly selected 11 meta-analyses that involved 127 RCTs on the efficacy of interventions used for circulatory and digestive diseases, mental health, and pregnancy and childbirth. We replicated all the meta-analyses using published data from the primary studies. The quality of reporting of all 127 clinical trials was assessed by means of component and scale approaches. To explore the effects of quality on the quantitative results, we examined the effects of different methods of incorporating quality scores (sensitivity analysis and quality weights) on the results of the meta-analyses.
The quality of trials was low. Masked assessments provided significantly higher scores than unmasked assessments (mean 2.74 [SD 1.10] vs 2.55 [1.20]). Low-quality trials (score < or = 2), compared with high-quality trials (score > 2), were associated with an increased estimate of benefit of 34% (ratio of odds ratios [ROR] 0.66 [95% CI 0.52-0.83]). Trials that used inadequate allocation concealment, compared with those that used adequate methods, were also associated with an increased estimate of benefit (37%; ROR=0.63 [0.45-0.88]). The average treatment benefit was 39% (odds ratio [OR] 0.61 [0.57-0.65]) for all trials, 52% (OR 0.48 [0.43-0.54]) for low-quality trials, and 29% (OR 0.71 [0.65-0.77]) for high-quality trials. Use of all the trial scores as quality weights reduced the effects to 35% (OR 0.65 [0.59-0.71]) and resulted in the least statistical heterogeneity.
Studies of low methodological quality in which the estimate of quality is incorporated into the meta-analyses can alter the interpretation of the benefit of intervention, whether a scale or component approach is used in the assessment of trial quality.
Clinicians can often find treatment recommendations in traditional narrative reviews and the discussion sections of original articles and meta-analyses. Making a treatment recommendation involves framing a question, identifying management options and outcomes, collecting and summarizing evidence, and applying value judgments or preferences to arrive at an optimal course of action. Each step in this process can be conducted systematically (thus protecting against bias) or unsystematically (leaving the process open to bias). Clinicians faced with a plethora of recommendations may wish to attend to those that are less likely to be biased. Therefore, we propose a hierarchy of rigor of recommendations to guide clinicians when judging the usefulness of particular recommendations. Recommendations with the highest rigor consider all relevant options and outcomes, include a comprehensive collection of the methodologically highest quality data with an explicit strategy for summarizing the data (that is, a systematic review), and make an explicit statement of the values or preferences involved in moving from evidence to action. High rigor recommendations come from systematically developed, evidence-based practice guidelines or rigorously conducted decision analyses. Systematic reviews, which typically do not consider all relevant options and outcomes or make the preferences underlying recommendations explicit, offer intermediate rigor recommendations. Traditional approaches in which the collection and assessment of evidence remains unsystematic, all relevant options and outcomes may not be considered, and values remain implicit, provide recommendations of weak rigor. In an era in which clinicians are barraged by recommendations as to how to manage their patients, this hierarchy provides a potentially useful set of guides.
Pressure garment use alters facial growth during rehabilitation after a facial burn injury. We previously studied 3 children with full facial burns and 3 children with partial facial burns who wore pressure garments for 1 year, and we found that maxillary horizontal growth and mandibular anterior-inferior growth are inhibited during the time of pressure garment use. The purpose of this follow-up study was to prospectively document skeletal and dental changes after pressure garment use was discontinued. We found that although the growth and development of the facial bones seem to return to normal, lasting changes remain. The use of pressure garments after skin grafting is still recommended. However, it is also recommended that an orthodontist be included in the team of burn care specialists for children with facial burns to monitor facial and dental development. Close attention to facial development during and after pressure garment use is necessary to maintain normal dental and facial relationships.
So far, little is known about the acoustic phenomena of high-frequency sonography for the assessment of healing processes in thermal wounds. However, ex vivo investigations have shown clear age-dependent differences in the rate of sound propagation in thermal scars compared to healthy skin. In order to answer the question of whether measurable acoustic characteristics of burn or scald scars can be classified in a way which corresponds to the clinical severity of the injuries, age of scar or type of treatment, 92 thermal scars, with an average scar age of 3.1 years, in 55 children were investigated with regard to corium thickness and echogenicity. A control group of 25 non-injured children of similar age was studied for comparison. It was shown that measurable echogenicity differences can allow conclusions about clinical severity to be drawn. The comparison of different therapeutic strategies showed no therapeutic effect either for compression or for the application of silicone gel sheets. In contrast, a decrease in scar thickness and a loosening of scar structure could be seen after early application of a sterile, silicone-covered polyamide net bandage. The 20-MHz-Sonography is a suitable non-invasive procedure for the characterisation of burn scars.
Scar formation after scald injury in children is managed commonly by application of pressure garment. The duration of the treatment depends on clinical assessment. The objective of the study was to evaluate the efficacy of the pressure garment therapy and to correlate the clinical assessment scar thickness with ultrasound measurement.
Prospective study of children with hypertrophic scars receiving pressure garment therapy was carried out between 1993 and 1998. The scars were mapped with paper cutting. Representative scar sites were scored clinically according to Vancouver General Hospital Burn Assessment Scale (pigmentation, vascularity, pliability, height, pain, itchiness). Blind to the clinical results, 2 radiologists measured the scar thickness of the same sites with ultrasonography (5 to 10 MHz transducer, General Electric LOGIQ 500). The correlation between the clinical scores and ultrasound measurement of scar thickness were analysed using analysis of variance (ANOVA).
The median age of 58 children with scald injury (M:F = 36:22) was 2.8 years (0.5 to 15.8 years). The mean percentage of scald was 8.8% (24% had scald area >10%). In addition, there were 5 children with burn from naked flame and 9 children with keloid secondary to surgical incisions. With pressure garment therapy, the scar thickness reached a plateau 1 (1/2) years after the injury and began to decline gradually thereafter. The clinical estimation of scar thickness correlated well with the ultrasound measurement (ANOVA, P =.003, Adjusted R square = 0.99). The accuracy rate of clinical thickness estimation was 67%. Overestimation and underestimation accounted for 15% and 18%, respectively. There also was good correlation between total clinical score and the ultrasound measurement (ANOVA, P <.001).
In children with scald injury, the pressure garment needs to be continued for a minimum of 1 year. Ultrasound measurement correlates well with overall score of the Vancouver General Hospital Burn Assessment Scale but not individual components of the scoring system except wound height.
A cohort study tracks two or more groups forward from exposure to outcome. This type of study can be done by going ahead in time from the present (prospective cohort study) or, alternatively, by going back in time to comprise the cohorts and following them up to the present (retrospective cohort study). A cohort study is the best way to identify incidence and natural history of a disease, and can be used to examine multiple outcomes after a single exposure. However, this type of study is less useful for examination of rare events or those that take a long time to develop. A cohort study should provide specific definitions of exposures and outcomes: determination of both should be as objective as possible. The control group (unexposed) should be similar in all important respects to the exposed, with the exception of not having the exposure. Observational studies, however, rarely achieve such a degree of similarity, so investigators need to measure and control for confounding factors. Reduction of loss to follow-up over time is a challenge, since differential losses to follow-up introduce bias. Variations on the cohort theme include the before-after study and nested case-control study (within a cohort study). Strengths of a cohort study include the ability to calculate incidence rates, relative risks, and 95% CIs. This format is the preferred way of presenting study results, rather that with p values.
Hypertrophic scarring after burns remains a major problem and is considered to be "common". Pressure garments are commonly used as treatment even though there is little sound data that they reduce the prevalence or magnitude of the scarring. In 1999 we began a study of the efficacy of pressure garments on forearm burns. After studying 30 patients, mainly white adults, we found no hypertrophic scar in either those treated with pressure or without. This prompted us to review the literature on the prevalence of hypertrophic scarring after burns and found only four articles with a relatively small number of patients and only three geographical locations. It became clear that the prevalence of hypertrophic scarring is really unknown. We then did a retrospective study of 110 burn survivors and counted all hypertrophic scars of all sizes and locations in all races and found the prevalence hypertrophic scarring to be 67% which conflicts with the published reports and our prospective study and suggests that further research is necessary. We concluded that a worldwide, prospective survey is necessary to establish the prevalence of hypertrophic scarring after burns. In this article we are calling for and offering to organize this survey.
Each year in Hong Kong, about 350,000 surgical procedures are conducted for various types of conditions. Previous review indicated that the prevalence of hypertrophic scar among Caucasians ranged from 15% to 63% and that the incidence was even higher among non-Caucasians. This study aims to find out the prevalence rate of hypertrophic scar among the Hong Kong Chinese population after standardized surgical procedures. A systematic and objective scar measurement protocol is implemented in this study. The spectrocolorimeter, Miniscan XE plus was used to measure the scar pigmentation based on the theory of the CIE colour model. The tissue ultrasound palpation system (TUPS) was employed to measure scar thickness. From May 2001 to December 2003, 154 patients, who received surgical intervention at the Department of Orthopaedics and Traumatology of a large regional hospital, were invited to join a scar-screening test. One hundred and fifteen patients (74.67%) were found to have signs of hypertrophic scar based on thickness, pliability, pigmentation and vascularity (using the Vancouver scar scale (VSS) score). One hundred and one patients consented to have more comprehensive scar assessment. Results indicated that the scar thickness was 4.91+/-1.03 mm. Compared with the adjacent normal skin, the color of hypertrophic scar was significantly different in terms of lightness (d.f.=100, t=-19.36, p<0.01), redness (d.f.=100, t=15.75, p<0.01) and yellowness (d.f.=100, t=-11.48, p<0.01) using paired t-test analysis. Fourtysix point five percent and 33.7% among patients reported pain (2.19+/-2.74) and itchiness (1.47+/-2.53) over the scar. The objective scar assessments showed that more than 70% of scars had increase in thickness and pigmentation after surgery. More than 40% of patients reported pain and itchiness. The results showed that more than 70% of the scars in the HK Chinese population had become hypertrophic in terms of pigmentation, thickness and physical symptoms such as pain and itchiness 1 month after the surgical intervention. More long-term follow up study should be done to find out the prevalence and that it is essential to provide early intervention before the scar becomes problematic in management.
The aim of this study was threefold: (1) Assess the pressure loss of two types of pressure garments that are used in the treatment of hypertrophic scars after burn injury, (2) investigate the influence of two different levels of compression on erythema and thickness of burn scars and (3) examine the association between erythema and thickness. The study was a prospective trial in which 76 burn scars in 60 patients were objectively assessed with the Minolta Chromameter CR-300 for erythema and with the Dermascan C for thickness of the scar over a period of 3 months. Each patient was randomly assigned to a "normal" or "lower" compression class treatment, with respectively mean values of 15 and 10 mmHg pressure after wearing the garment for 1 month. Measurements for both parameters were taken at 0, 1, 2 and 3 months of treatment. Pressure garments with "normal" compression did lose significantly more compression over 1 month (4.82 mmHg) than did the garments from the low compression class (2.57 mmHg). Scars that were treated with garments from a "normal" compression class did score significantly better for thickness compared to the "low" compression class. The difference in thickness was most evident at 1 month. Thereafter no further significant improvement between the two different treatments over time could be obtained. This difference was not found for erythema. Positive correlations could be found between erythema and thickness values at all of the three test points while changes in erythema and thickness only correlated significantly after the first month. The pattern of change of both parameters correlated at a high level of significance after 3 months of treatment. These data suggest that pressure garments that deliver a pressure of at least 15 mmHg pressure tend to accelerate scar maturation and that measurements of the pattern of change of the erythema can be used to predict changes in scar thickness and vice versa.
Prospective, randomized, controlled study of pressure garment therapy in the treatment of post-burn hypertrophic scarring
- E E Tredget
- H A Shankowsky
- S Mathey
Tredget EE, Shankowsky HA, Mathey S. Prospective,
randomized, controlled study of pressure garment therapy in
the treatment of post-burn hypertrophic scarring. In: Anzarut
A, editor. Edmonton; Unpublished.
National Rehabilitation Information Center
- L H Engrav
- Agustin T San
- Naric
Engrav LH, San Agustin T. NARIC: National Rehabilitation Information Center. <http://www.naric.com>; 2007 [December 27].
Completeness of reporting of trials published in languages other than English: implications for conduct and reporting of systematic reviews [see comment]
- D Moher
- P Fortin
- Jadad
- Ar
Moher D, Fortin P, Jadad AR, et al. Completeness of reporting of trials published in languages other than English: implications for conduct and reporting of systematic reviews [see comment]. Lancet 1996;347:363e6.
Pressure Garment Therapy Costs
- Captial_Health_Authority
Captial_Health_Authority. Pressure Garment Therapy Costs. In: Personal_Communication, editor.