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Negative pressure wound therapy after partial diabetic foot amputation: A multicentre, randomised controlled trial

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Abstract

Diabetic foot wounds, particularly those secondary to amputation, are very complex and difficult to treat. We investigated whether negative pressure wound therapy (NPWT) improves the proportion and rate of wound healing after partial foot amputation in patients with diabetes. We enrolled 162 patients into a 16-week, 18-centre, randomised clinical trial in the USA. Inclusion criteria consisted of partial foot amputation wounds up to the transmetatarsal level and evidence of adequate perfusion. Patients who were randomly assigned to NPWT (n=77) received treatment with dressing changes every 48 h. Control patients (n=85) received standard moist wound care according to consensus guidelines. NPWT was delivered through the Vacuum Assisted Closure (VAC) Therapy System. Wounds were treated until healing or completion of the 112-day period of active treatment. Analysis was by intention to treat. This study has been registered with , number NCT00224796. More patients healed in the NPWT group than in the control group (43 [56%] vs 33 [39%], p=0.040). The rate of wound healing, based on the time to complete closure, was faster in the NPWT group than in controls (p=0.005). The rate of granulation tissue formation, based on the time to 76-100% formation in the wound bed, was faster in the NPWT group than in controls (p=0.002). The frequency and severity of adverse events (of which the most common was wound infection) were similar in both treatment groups. NPWT delivered by the VAC Therapy System seems to be a safe and effective treatment for complex diabetic foot wounds, and could lead to a higher proportion of healed wounds, faster healing rates, and potentially fewer re-amputations than standard care.

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... Despite the increasing use of NPWT as a treatment for SWHSI, there is limited robust evidence to evaluate the effectiveness and cost-effectiveness of this treatment for this patient group. A Cochrane review identified three randomised controlled trials [11][12][13][14] of NPWT as a treatment for SWHSI; however, all were small and caution was advised when interpreting the findings [9,15]. The clinical and cost-effectiveness and the harms and benefits of NPWT in the treatment of SWHSI therefore remain uncertain. ...
... To detect a 25% reduction in median time to healing (from 86 days with usual care to 65 days with NPWT), with 90% power, 12-month follow-up, and allowing for 20% attrition [8,13,21], 696 participants are required to be recruited and randomised (348 NPWT; 348 usual care). ...
... -Current literature. The average median time to healing in the control group of previous observational and randomised controlled trials is 86 days, with an average decrease in time to healing of 25% when NPWT is used [11][12][13]22]. -Significance to patients. ...
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Background The majority of surgical wounds are closed (for example with sutures or staples) and so heal by primary intention. Where closure is not possible, or the wound subsequently breaks down, wounds may be left to heal from the bottom up (healing by secondary intention). Surgical wound healing by secondary intention (SWHSI) frequently presents a significant management challenge. Additional treatments are often required during the course of healing, and thus a significant financial burden is associated with treating these wounds. Increasingly, negative pressure wound therapy (NPWT) is used in the management of SWHSI. This wound dressing system provides a negative pressure (vacuum) to the wound, removing fluid into a canister, which is believed to be conducive to wound healing. Despite the increasing use of NPWT, there is limited robust evidence for the effectiveness of this device. A well-designed and conducted randomised controlled trial is now required to ascertain if NPWT is a clinically and cost-effective treatment for SWHSI. Methods SWHSI-2 is a pragmatic, multi-centre, cross surgical specialty, two arm, parallel group, randomised controlled superiority trial. Adult patients with a SWHSI will be randomised to receive either NPWT or usual care (no NPWT) and will be followed up for 12 months. The primary outcome will be time to healing (defined as full epithelial cover in absence of a scab) in number of days since randomisation. Secondary outcomes will include key clinical events (hospital admission or discharge, treatment status, reoperation, amputation, antibiotic use and death), wound infection, wound pain, health-related quality of life, health utility and resource use. Discussion Given the increasing use of NPWT, despite limited high-quality supporting evidence, the SWHSI-2 Trial will provide robust evidence on the clinical and cost-effectiveness of NPWT in the management of SWHSI. The SWHSI-2 Trial opened to recruitment in May 2019 and is currently recruiting across 20 participating centres. Trial registration ISRCTN 26277546. Prospectively registered on 25 March 2019
... Накоплены убедительные данные о том, что использование подобных аспирационных повязок улучшает результаты лечения ран средней сложности за счет снижения риска послеоперационных инфекционных осложнений и при повышенном риске инфицирования (кесарево сечение, длительные торакальные, абдоминальные или ортопедические вмешательства, операции продолжительностью более трех часов и т. д.) [5][6][7][8][9]. ...
... Ce pansement aspiratif est considéré comme améliorant la cicatrisation des plaies moyennement complexes, les preuves cliniques devenant plus convaincantes dans les plaies postopératoires où ce type depansement limite le risque d'infection post-pératoire sur une plaie à risque (césarienne, chirurgie thoracique ou abdominale longue, chirurgie orthopédique, chirurgie de durée supérieure à trois heure, etc.) [5][6][7][8][9]. ...
Article
NPT is part of the daily management of complex wounds with delayed healing. It is essential in 2018 to understand the mechanisms of action of the various machines available on the wound market in France. In order to put the right indication for a defined clinical problem to know the difference between fixed and heavy techniques, imposing immobilization of the patient due to the need for a permanent connection and the simpler, ambulatory techniques that combine effective negative pressure while allowing a better quality of life. The recent contribution of the instillation has completed the offer by opening the possibility of instilling in the wound variable liquids in their composition and their effect. The recent introduction of a new foam also suggests the possibility of cleaning the wound with a tool hitherto reserved for the promotion of granulation tissue.
... 17 Armstrong et al found that patients who were managed by VAC therapy grew granulation tissue at a faster rate compared to the group that underwent conventional dressing. 18 These outcomes are similar to the ones we have obtained from the study. Honnegowda et al also found increased blood flow and blood vessels in patients treated with VAC therapy than in conventional dressing. ...
... Zhang et al showed in their study that VAC therapy showed increase in miR-126 in animal models, which regulates VEGF induced angiogenesis. 19 18,11 Air leak, concealing an underlying infection, inadequate debridement, bleeding as a culture medium for the organisms are all possible causes of such infection. 11 Rastogi et al also have compared many such studies on diabetic foot and have found Pseudomonas aeruginosa to be the most common organism to be isolated from such wounds. ...
Article
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Background: Diabetes mellitus and its complications are rising. Managing the diabetic foot wound is very challenging. Early intervention and intense management using modern technique will improve the diabetic wounds for a definitive procedure and also prevent, reduce the level of amputation of extremity. Our study compares the microbiological and histopathological results of diabetic wounds managed by conventional dressing and VAC (vacuum assisted closure) therapy.Methods: This was an institutional based prospective study conducted between July 2018 and July 2019 consisting of 50 patients with diabetic wound of lower extremities. Patients were divided into group A- 25 patients underwent conventional dressing and group B- 25 patients underwent negative pressure wound therapy (NPWT). Wound swab and tissue biopsy was obtained on day 0 and day 10 from both groups and compared.Results: Among patients, 76% and 24% were males and females respectively. Histopathologically, necrosis and inflammatory cell infiltrate were significantly decreased in group B compared to group A. Angiogenesis increased notably in group B. On microbiological grounds, from both groups Pseudomonas aeruginosa was found to be the most common organism on day 0 and 10. But the prevalence of infection in group B was grossly reduced when compared to group A.Conclusions: VAC therapy is a better modality to treat diabetic wound compared to conventional dressing as it accelerates the healing of a chronic wound by increasing angiogenesis and decreasing necrosis, inflammatory cell infiltrate and microbial growth.
... Thus it helps in wound bed optimization and is a more effective therapy than VAC alone. [6] Wound assessment is another aspect of DFU management for deciding whether the wound is prepared or not for coverage. The present study uses DEPA score as a wound assessment tool in DFU and attempts to address the benefits of NPWT with irrigation of normal saline in wound bed preparation. ...
... [12][13][14][15] Other studies also suggest that NPWT is more effective than these wound dressing and topical antimicrobial. [6,16] NPWT with irrigation is a modification of the conventional NPWT therapy, combining the benefits of NPWT with controlled delivery of topical solutions [such as cleansers (normal saline), antiseptics, and antibiotics to the wound bed]. This modification involves the instillation of substances into the sealed wound via an additional tubing system while the vacuum pump is paused. ...
Article
Introduction: Diabetic foot ulcer (DFU) is a common complication of uncontrolled diabetes. Negative pressure wound therapy (NPWT) with irrigation of normal saline is one of the methods for wound care and dressing techniques in DFU. Wound assessment is another aspect of DFU management for deciding whether the wound is prepared or not for coverage. The present study uses DEPA score as a wound assessment tool in DFU. Materials and Methods: This case series include 11 patients with DFU who were treated using NPWT with simultaneous irrigation of normal saline. Results: All 11 patients were male and age more than 60. Most patients have duration of diabetes for less than 10 years. Staphylococcus aureus (n = 5, 45.4%) was most common bacterial flora. Most patients in series presented with DEPA score more than 7 and after application of NPWT instillation therapy significant improvement seen with score in most of the patient with DEPA score below 6. Mean time for NPWT (irrigation) application was 15 days. Mean time of wound preparation was 18.7 days. Final surgical procedures executed in all patients, split skin grafting performed in 7 patients. 4 patients had wound coverage by reverse sural flap (2), medial plantar flap (1) and local flap coverage (1). Conclusion: NPWT with normal saline irrigation is an effective method of wound preparation in DFU. DEPA score is an important tool for assessment of wound preparation which gives exact information for timing of wound coverage once diabetic foot wound is prepared.
... The results revealed that more NPWT patients healed, with a reduction in the healing time and a faster formation of granulation tissue. 8 Another multicenter randomized controlled study involved 342 patients. A greater proportion of foot ulcers achieved complete ulcer closure with NPWT than with advanced moist wound therapy (AMWT). ...
Article
Full-text available
Diabetic foot is one of the main chronic complications caused by diabetes mellitus and can lead to limb amputation. Among the various wound treatment options, negative pressure wound therapy is a treatment modality based on vacuum-sealed drainage and vacuum-assisted closure to create a localized controlled negative pressure environment. In this case report, the patient sought medical attention and underwent surgical debridement of the dorsum of the right foot. Upon worsening of the wound condition, the patient was referred to our hospital for debridement and Renesys Smith Nephew dressing was implanted. After complete coverage of the granulation tissue without infection, elastic suturing was performed in the leg compartment to reduce the size of the dermis and epidermis graft. The patient then underwent a dermal matrix implant procedure, and an epidermis graft was removed from the ipsilateral thigh and placed on the wound. The aim of this study is to report a therapeutic challenge in an extensive wound in diabetic foot using a dressing negative pressure wound therapy and multidisciplinary treatment.
... Wounds after extremity or toe amputations (without condition of primary suture) NPWT is recommended for the treatment of stump wounds to promote granulation tissue proliferation and tissue reconstruction after the risks of ischemia and bleeding are reduced, necrotic tissue is cleared and infection is controlled [160,161]. The IPT (suction for 5 minutes, pause for 2 minutes) or VPT mode should be applied, with pressures between −80 mmHg and −60 mmHg or −80 mmHg and −10 mmHg, respectively, for 3-5 days according to wound exudation. ...
Article
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Because China is becoming an aging society, the incidence of diabetes and diabetic foot have been increasing. Diabetic foot has become one of the main health-related killers due to its high disability and mortality rates. Negative pressure wound therapy (NPWT) is one of the most effective techniques for the treatment of diabetic foot wounds and great progress, both in terms of research and its clinical application, has been made in the last 20 years of its development. However, due to the complex pathogenesis and management of diabetic foot, irregular application of NPWT often leads to complications, such as infection, bleeding and necrosis, that seriously affect its treatment outcomes. In 2020, under the leadership of Burns, Trauma and Tissue Repair Committee of the Cross-Straits Medicine Exchange Association, the writing group for ‘Consensus on the application of negative pressure wound therapy of diabetic foot wounds’ was established with the participation of scholars from the specialized areas of burns, endocrinology, vascular surgery, orthopedics and wound repair. Drawing on evidence-based practice suggested by the latest clinical research, this consensus proposes the best clinical practice guidelines for the application and prognostic evaluation of NPWT for diabetic foot. The consensus aims to support the formation of standardized treatment schemes that clinicians can refer to when treating cases of diabetic foot.
... According to estimates, every half a minute a patient with diabetes mellitus loses a leg due to an amputation [2]. The life expectancy rate among individuals who have been subjected to major amputation procedures is low and is comparable to survival rates in cancer patients (5-year mortality rates up to 55% for colon cancer vs. 73% in lower limb amputation) [3]. According to Schofield et al. [4], diabetes itself is a marker of mortality, with people with diabetes mellitus having a 55% greater risk of death than those without the disease. ...
Article
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Background: This study aimed to explore the effect of haematological markers as well as patient characteristics on stump healing in patients who underwent a lower limb amputation procedure. In addition, a practical model regarding factors that affected stump healing was developed. Methods: Patients who underwent a major lower limb amputation (above knee and below knee) at the Royal Infirmary of Edinburgh from the period of 2007 to 2010 were included in this study. A prognostic model utilizing backward stepwise logistical regression was developed to measure the probability of lower limb stump healing. The relationship between the dependent and independent variables was identified using univariate and multivariate logistic regression. Results: Three variables, namely serum sodium, serum creatinine and serum high density lipid cholesterol were identified which influenced stump healing. Patients with normal serum sodium were 75% more likely to have lower limb stump healing compared to that of patients with abnormal serum sodium (odds ratio [OR] 1.756; 95% confidence interval [CI] 1.048–2.942). Patients with normal serum creatinine were 66% more likely to have their stump healed (OR 1.664; 95% CI 0.94 to 2.946). The healing rate of patients with a normal level of serum high density lipid cholesterol was 75%, in contrast to patients with an aberrant level of serum high density lipids cholesterol (OR 1.753; 95% CI 1.061 to 2.895). The effectiveness of the retrospective stump-healing model was demonstrated by the area under the ROC curve (0.612), which was supported by the Hosmer and Lemeshow goodness-of-fit test (p = 0.879). Conclusions: Serum sodium, serum high density lipid cholesterol and serum creatinine have a strong correlation with lower limb stump healing. However, serum sodium and serum high density lipid cholesterol secondary to multiple co-morbidities in this cohort group could be altered secondary to disease pathology itself.
... Wound management has been a challenging problem over the years requiring innovative methods of treatment to improve wound granulation and contraction, minimize the dressing and nursing requirement, and dramatically reduce the cost associated with wound management [1][2][3][4][5]. Managing acute wounds with negative pressure wound therapy (NPWT) at subatmospheric pressure is safe and effective [6,7]. ...
Article
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Introduction. The negative pressure system has been found to be a valuable addition to the various procedures of wound management and has been widely accepted to be safe and effective in promoting wound healing. Aim. The study seeks to find out the outcome of the use of the VAC device in the treatment of patients with acute wounds. Materials and Methods. Between January 2009 and December 2011, a consecutive nonrandomized study was conducted among 48 patients who presented with acute wounds at the Komfo Anokye Teaching Hospital. Patients were made to undergo negative pressure wound therapy using the VAC device. Results. Forty-eight patients with various degrees of acute wounds were treated, of which 43 (89.6%) were females and 5 (10.4%) were males. Ages of patients ranged from 19 to 78 years. Satisfaction with rate of wound healing revealed that 86.7% and 8.9% had excellent and good healing, respectively, while 4.4% said theirs was satisfactory. Therapy was discontinued in three (6.3%) patients who developed some complications. Conclusion. There was reduction in the hospitalization by patients thereby reducing costs. Also, quality of life of persons who had undergone the therapy with the VAC device had improved. Even though a few device-related complications were observed, patient satisfaction was high.
... Same for Clare et al., who suggested to treat those with severe peripheral vascular disease with other modalities explaining it by the fact that the overall rate of wound healing is limited by the available vascular supply [10,14]. ...
... So it can be concluded that significant number of patients in group A achieved wound healing earlier in comparison to group B. Armstrong et al observed that median time to complete closure was 56 days in VAC therapy group against 77 days in the conventional saline dressing group. 10 In the present study mean duration of hospital stay in days was found to be 35.50 days with a SD of ±7.63 in group A while it was found to be 42.42 days with a SD of ±6.73. ...
Article
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Background: Lower limb ulcer is a common disease among the Indian population with a prevalence of approximately 1% to 2% which is slightly higher in the older population. There are various modalities of treatment with the main aim being early wound healing. This study is done to compare the results of negative pressure dressing and conventional dressing in lower limb ulcers.Methods: This study, done at the Department of Surgery, G. K. General Hospital and Gujarat Adani Institute of Medical Sciences, Bhuj, from October 2017 to September 2018 is a prospective study. A total of 120 patients were randomly divided in two group comprising of 60 patients each. The patients in Group A were treated with negative pressure dressing while those in Group B were treated with conventional dressing. The patients were assessed, in both test and control groups, with parameters like appearance of granulation tissue, bacterial clearance and wound healing.Results: 80% of the patients belonged to the age group of 41-60 years while others were less than 40 years. We observed that in Group A majority of the patients had wound healing in 11-40 days while in Group B majority patients took 31-60 days for their wounds to be healed.Conclusions: We conclude that negative pressure dressing is more efficient as compared to conventional dressing for healing of lower limb ulcers, enabling a shorter hospital stay and early resumption of daily activities to the patient.
... Although the effectiveness of negative pressure wound therapy (NPWT) for the diabetic foot ulcer is well known [3], CLI patients treated with NPWT show the highest frequency of complications such as erosion, blister, and skin ulcer surrounding the wound [4]. ...
Article
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Introduction The treatment of intractable toe ulcer with critical limb ischemia (CLI) is a challenge because of its poor blood flow and the wound. Here, a novel fixation technique for artificial dermis with negative pressure wound therapy (NPWT) was reported. Method After the amputation of toe, artificial dermis made of collagen-gelatin sponge (CGS) was grafted onto the wound where human recombinant basic fibroblast growth factor (bFGF) was sprayed. The foot was put on adhesive iodine-impregnated drape, the artificial-dermis area was covered with a sponge dressing of which another end reached to the drape, and the vacuum port was applied on the dressing sponge sandwiched with two drapes and connected to an NPWT system. Since the shape of sponge-dressing was similar to that of elephant-trunk, the technique in this study was named an “Elephant-trunk” technique. Result During NPWT period, no complications such as air leakage, skin erosion, ischemic around tissue were confirmed. The artificial dermis was engrafted completely at one week after surgery, and the wound was confirmed to close completely. Conclusion This NPWT technique with bFGF and CGS accelerated the healing of wound treated conservatively with artificial dermis in CLI patients.
... Neuropathic lesions, stages 2 or 3 by Wagner's scale. calcaneal, dorsal, or plantar foot ulcer ≥ 2 cm2 in area after debridementNegative pressure therapy appears to be as safe as and more efficacious than advanced moist therapy for the treatment of diabetic foot ulcers.Not reportedArmstrong D, et al.[81].162 patients into a 16-week, 18-centre, randomized clinical trial in the USA. ...
... Negative pressure wound therapy (NPWT) has remained an integral part of wound management for general, orthopedic, and plastic surgeons for more than half a decade [1][2][3][4]. Adjustable negative pressure applied via an adhesive film over a foam padding promotes wound healing by removing wound exudate and decreasing interstitial edema and bacterial load at the wound site. This results in increased tissue perfusion and promotes the formation of a well-granulating wound bed [5][6][7]. ...
Article
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(1) Background: Negative pressure wound therapy (NPWT) has been effectively used for wound management in comparison to traditional dressings. The purpose of this study was to provide an evidence-based review of NPWT in head and neck cancer patients, as well as the impact of previous irradiation and other risk factors on wound healing. (2) Material and Methods: We conducted a comprehensive search in PubMed, Medline, Embase, Web of Science, and Cochrane Library databases for relevant literature. (3) Results: 15 studies fulfilled the inclusion criteria. The most common etiologies requiring NPWT were defects post tumor resection and flap reconstruction and oro/pharyngo-cutaneous fistulas. The neck was found to be the most common site of involvement (47.3%). The overall wound healing response rate was 87.5%. The median negative pressure recorded was 125 mm of Hg, with a median dressing change time of three days. Previous irradiation (p = 0.01; OR = 4.07) and diabetes mellitus (DM) (p = 0.001; OR = 5.62) were found to be significantly associated with delayed wound healing after NPWT. (4) Conclusion: NPWT treats complex wounds in head and neck cancer patients and should represent a significant armamentarium in head and neck cancers. Previous irradiation and DM have detrimental effects on wound healing after NPWT.
... Despite the claim that NPWT for the management of soft tissue defects can contribute to fast and safe infection control [15,44], based on the best available evidence presented in this paper, the overall infection recurrence of FRI treated with NPWT ranges from 2.8% up to 34.9% [30][31][32][33][34][35][36][37]. In this perspective, several caveats should be considered. ...
Article
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Introduction: Fracture-related infection (FRI) is a severe musculoskeletal complication in orthopedic trauma surgery, causing challenges in bony and soft tissue management. Currently, negative-pressure wound therapy (NPWT) is often used as temporary coverage for traumatic and surgical wounds, also in cases of FRI. However, controversy exists about the impact of NPWT on the outcome in FRI, specifically on infection recurrence. Therefore, this systematic review qualitatively assesses the literature on the role of NPWT in the management of FRI. Methods: A literature search of the PubMed, Embase, and Web of Science database was performed. Studies that reported on infection recurrence related to FRI management combined with NPWT were eligible for inclusion. Quality assessment was done using the PRISMA statement and the Newcastle-Ottawa Quality Assessment Scale. Results: After screening and quality assessment of 775 unique identified records, eight articles could be included for qualitative synthesis. All eight studies reported on infection recurrence, which ranged from 2.8% to 34.9%. Six studies described wound healing time, varying from two to seven weeks. Four studies took repeated microbial swabs during subsequent vacuum dressing changes. One study reported newly detected pathogens in 23% of the included patients, and three studies did not find new pathogens. Conclusion: This review provides an assessment of current literature on the role of NPWT in the management of soft tissue defects in patients with FRI. Due to the lack of uniformity in included studies, conclusions should be drawn with caution. Currently, there is no clear scientific evidence to support the use of NPWT as definitive treatment in FRI. At this stage, we can only recommend early soft tissue coverage (within days) with a local or free flap. NPWT may be safe for a few days as temporarily soft tissue coverage until definitive soft tissue management could be performed. However, comparative studies between NPWT and early wound closure in FRI patients are needed.
... To date, effective treatments, such as negative pressure wound therapy (NPWT), are commonly used to treat various intractable wounds (1)(2)(3)(4). NPWT produces a conducive microenvironment for the stimulation of granulation tissue and subsequent wound healing via open-cell foam dressing and negative pressure (5). Several mechanisms of action underlying NPWT have been proposed, including the reduction of wound tissue edema and bacterial colonization, promotion of cell proliferation and increased local blood perfusion (5)(6)(7)(8). ...
Article
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Negative pressure wound therapy (NPWT) has been recognized as an effective method for the treatment of intractable wounds. However, its effects on bone healing remain to be elucidated. Our previous study demonstrated that NPWT induced cell proliferation and osteoblastic differentiation of rat periosteum-derived mesenchymal stem cells (P-MSCs). It was reported that following NPWT treatment, the expression of the mechanotransduction molecule integrin β5 is increased, indicating that NPWT may serve an active role in fracture healing by enhancing bone formation and reducing bone resorption. The present study sought to further investigate the efficacy of NPWT on the bone regeneration process in a rabbit radial gap-healing model. All rabbits with radial defects were randomly divided into two groups: NPWT and control groups. Continuous negative pressure at -125 mmHg was applied to all rabbits. Furthermore, X-ray imaging and scoring on day 7, 14, 21 and 28 postoperatively were performed to evaluate new bone formation. Histological changes were determined via hematoxylin and eosin and Masson's trichrome staining at 2- and 4-weeks following surgery. In addition, vimentin-positive cells located in the periosteum were detected via immunohistochemical examination on day 3 post operation. Finally, protein expression levels of vascular endothelial growth factor (VEGF), bone morphogenetic protein (BMP)-2 and osteopontin (OPN) were evaluated using western blot analysis on the 2nd and 4th week following NPWT. X-ray and histological examination revealed that the bone-healing processes in the NPWT group were faster compared with the control group. Additionally, compared with the control group, the NPWT group exhibited higher X-ray scores, increased percentage of positive vimentin-stained cells and upregulated expression of VEGF, BMP-2 and OPN proteins. The aforementioned findings suggest that NPWT, under a continuous negative pressure of -125 mmHg, may accelerate bone regeneration by enhancing MSC proliferation, osteoblastic differentiation and VEGF, BMP-2 and OPN expression.
... By shrinking the wound edges, increasing blood flow, promoting granulation, reducing edema, and removing excess exudates, negative pressure wound therapy (NPWT) promotes wound healing through the application of negative pressure to wounds, such as pressure ulcers, acute traumatic wounds, chronic intractable wounds, and postoperative wound infections [8][9][10][11]. It has been widely used in Europe and the United States since 1995 and has been covered by the medical insurance of the Ministry of Health, Labor, and Welfare of Japan since 2010. Recently, the efficacy of incisional NPWT (iNPWT) for the prevention of wound complications in closed surgical incisions has been reported [12]. ...
Article
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Background The American Society of Surgery and American Society for Surgical Infections issued guidelines for surgical site infections (SSIs) in December 2016. These guidelines recommend a purse-string suture (PSS) for stoma closure as it facilitates granulation and enables open wound drainage. This study investigated the effect of using negative pressure wound therapy (NPWT) along with standard PSS and aimed to determine the optimal period of NPWT use. Methods The patients were divided into three groups as follows: Group A, postoperative wound management alone with gauze exchange as the representative of conventional PSS; Group B, the performed management was similar to that of Group A plus NPWT for 1 week; and Group C, the performed management was similar to that of Group A plus NPWT for 2 weeks. Regarding objective measures, the wound reduction rate was the primary outcome, and the incidence of SSIs, length of hospital stay, and wound healing duration were the secondary outcomes. Results In total, 30 patients (male: 18, female: 12) were enrolled. The average age was 63 (range: 43–84) years. The wound reduction rate was significantly higher in Group B than in Group A on postoperative days (PODs) 7 (66.1 vs. 48.4%, p = 0.049) and 10 (78.6 vs. 58.2%, p = 0.011), whereas no significant difference was observed on POD 14. Compared with Group A, Group C (POD 7: 65.9%, POD 10: 69.2%) showed an increase in the wound reduction rate on POD 7, although the difference was not significant (p = 0.075). SSIs were observed in Groups B (n = 2) and C (n = 2) (20%) but not in Group A (0%). Conclusions The most effective duration of NPWT use for ileostomy closure with PSS in terms of the maximum wound reduction rate was from PODs 3 to 10. However, NPWT did not shorten the wound healing duration. NPWT may reduce the wound size but should be used with precautions for SSIs. The small sample size (30 cases), the use of only one type of NPWT system, and the fact that wound assessment was subjective and not blinded were the limitations of this study. Further studies are needed to confirm our findings. Trial registration: UMIN Clinical Trials Registry; UMIN000032174 (10/04/2018).
... Some randomized trials have been conducted in the recent past and proved the efficacy of the vacuum dressing on wounds [20][21][22][23]. A randomized trial by Apelqvist et al. showed that there was a utilization of fewer resources and that a greater proportion of patients showed wound healing at a lower overall cost of care as compared to routine dressing [24]. ...
Article
Introduction Isn't it a boon that all living organisms possess the ability to heal their injuries? The wound healing is faster when the normal physiology of the wound healing is maintained. Our understanding of wound healing has undergone dramatic changes in the recent past. Almost all materials and methods available on earth have been used and tested to facilitate the process of wound healing. The mental agony and the disability suffered by patients with chronic ulcers have led to the reappraisal of the basic components of the wound healing process and how they are influenced by biological, mechanical, and physical forces. The Department of General Surgery in our Government Chengalpattu Medical College and Hospital, Chengalpattu, Tamil Nadu, India, admits and treats a large volume of patients with wounds and ulcers. Here many materials are being used regularly for dressing to make wound healing faster. Vacuum dressings were also done on many patients, and promising results were observed. This kindled our interest in conducting this prospective study and comparing wound healing with vacuum dressing versus normal saline dressing. Materials and methods A total of 74 patients were included in the study, out of which 37 patients were randomly included in the experimental group and vacuum dressing was done, while the other 37 included in the control group were treated with dressing done with normal saline moistened gauze and bandage roll. Rates at which the wound healed were compared. Results We were able to observe a statistically significant difference in the rate of appearance of granulation tissue between the two and increased clearance of bacteria and toxins. The study group promised better progress as compared to the control group in various aspects. Conclusion Vacuum dressing brings an obvious improvement in the healing of non-healing ulcers and decreases the overall duration of stay in the hospital.
... Advanced therapies are a promising alternative and one of the fastest growing markets for treatment of chronic wounds and includes devices or products such as negative wound pressure therapy [16,17], hyperbaric oxygen therapy [18], extracorporeal shock wave stimulation [19], special purpose dressings [20][21][22], skin grafts and bioengineered skin [23], drugs or biologics such as locally administered growth factors [24]. Regarding pharmacological and/or medicinal wound healing products for DFUs, so far only growth factors and tissue-based substitution components have gained approval in the US and other major countries. ...
Article
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Diabetes mellitus is one of the major concerns for health care systems, affecting 382 million people worldwide. Among the different complications of diabetes, lower limbs chronic ulceration is a common, severe and costly cause of morbidity. Diabetic foot ulcers are a leading cause of hospitalization in diabetic patients and its rate exceed the ones of congestive heart failure, depression or renal disease. Diabetic non-healing ulcers account for more than 60% of all non-traumatic lower limb amputations and the five-year mortality after amputation is higher than 50%, being equal to several types of advanced cancer. The primary management goals for an existing diabetic foot ulcer are to achieve primary healing as expeditiously as possible and to achieve a reduction of the amputation rate in the patients. Unfortunately, approximately a quarter of patients do not partially or fully respond to the standard of care. Advanced therapies for chronic wounds are existing, however, recent guidelines including the latest reviews and meta-analyses of the scientific and clinical evidence available from current treatment strategies and new therapeutic agents revealed that there is a lack of clinical data and persistent gap of evidence for many of the advanced therapeutic approaches. In addition, no pharmacological wound healing product has gained authority approval for more than 10 years in both US and EU, constituting a highly unmet medical need. In this publication we present data from a live biopharmaceutical product AUP1602-C designed as a single pharmaceutical entity based on the non-pathogenic, food-grade lactic acid bacterium Lactococcus lactis subsp. cremoris that has been genetically engineered to produce human fibroblast growth factor 2,interleukin4 and colony stimulating factor 1. Designed to address different aspects of wound healing (i.e. fibroblast proliferation, angiogenesis and immune cell activation) and currently in phase I clinical study, we show how the combination of the individual components on the wound micro-environment initiates and improves the wound healing in chronic wounds.
... The regulations [4,8,10,11], recommend the ideal pressure in the local neighborhood of 120 mmHG of suction. Regulatory constraints recommend maintaining pressure ranges between 50 mmHG and 150 mmHG, depending on the wound size, equipment type, wound dressing, application cycles, and overall duration [4,8,[17][18][19][20]. ...
Article
This paper proposes a novel method for offline outlier detection in nonlinear dynamical systems using an input–output dataset of a Topical Negative Pressure Wound Therapy Device, NPWT. The fundamental characteristics of an NPWT describe a chaotic system whose states vary over time and may result in unpredictable and possibly anomalous divergent behavior in the presence of perturbations and other unmodeled system dynamics, despite a quasi-stable controller. Bacterial Memetic Algorithm, BMA, is used to generate fuzzy rule-based models of the input–output dataset. The error definition in the fuzzy rule extraction features a novel application of the Canberra Distance. The optimal number of rules for identifying the outliers, validated against both artificial and real system datasets, is calculated from the sample of inferred fuzzy models. The optimal number of rules is two in both cases based on the maximum average-error-drop. Using three or more rules results in better error performance; however, the algorithm learns the nuances of the outlier patterns instead. Novel methods for creating the outlier list and determining the optimal number of rules for the outlier detection problem are proposed.
... Unlike manual fixation techniques, NPWT applies negative pressure to the space between the skin graft and the recipient site: it removes space and pulls the entire skin graft with uniform pressure. Laboratory and clinical studies have shown that NPWT increases wound blood flow, oxygen concentration, and granulation tissue formation and decreases the accumulation of fluid and bacteria (17,18). Several studies have demonstrated that NPWT can be used successfully for securing skin grafts, especially in exudative, irregular, or mobile recipient wounds and in complex anatomic sites (19)(20)(21). ...
Article
Background: Graft fixation is essential for the successful survival of skin grafts. Negative-pressure wound therapy (NPWT) can be utilized for fixing a skin graft, ensuring adhesion of the graft with continuous and uniform pressure. However, the reported short- and long-term efficacy of NPWT in split-thickness skin grafts (STSGs) is inconsistent, with few studies on the long-term efficacy (scar quality). To clarify the appropriate methods of skin graft fixation, we conducted a single-center retrospective study on the shortand long-term effects of skin grafting using different fixation methods. Methods: This study retrospectively analyzed patients who underwent STSG from December 2010 to June 2019. The patients were divided into two groups based on the skin graft-fixing method: an NPWT group and a conventional mechanical fixation group. Medical data including age, sex, underlying diseases, wound etiology, recipient site, surgical methods, surgical outcomes, postoperative complications, and follow-up data (Vancouver Scar Scale score and Patient and Observer Scar Assessment Scale score) were analyzed. Results: A total of 392 cases were ultimately included in the analysis. Among them, 218 cases were fixed with NPWT for skin grafting and 174 with conventional mechanical fixation. No significant differences in baseline data were noted between the two groups. The total graft survival rate in the NPWT group was higher than that in the conventional mechanical fixation group (86.7% vs. 74.1%, P=0.002). Moreover, the infection rate in the NPWT group was lower than that in the conventional mechanical fixation group (5.5% vs. 13.2%, P=0.008). In terms of scar quality, no significant difference was observed, except for in the hand. Overall, the scar surface regularity was better in the NPWT group than in the control group. (P=0.019 for Patient Scar Assessment Scale, P=0.025 for Observer Scar Assessment Scale). Conclusions: NPWT is an effective approach for fixing skin grafts. Compared with conventional mechanical fixation, NPWT can significantly improve the survival rate and reduce the infection rate of STSG. In the long-term, NPWT can also improve scar surface regularity in the hand, with an esthetic effect that is more satisfactory to clinicians and patients.
... Managing deep soft tissue wounds in diabetic patients who suffer from severe osteomyelitis can be difficult because of the complexity and magnitude of subsequent soft tissue defects [4][5][6][7][8][9]. In such cases, multidisciplinary and advanced wound care techniques, including negative pressure wound therapy (NPWT) and an ideal wound healing dressing, are usually needed to enhance wound healing and increase the formation of granulation tissue [10][11][12]. In this case study, we report the use of Nanoflex powder (Altrazeal, Uluru, Inc., Addison, Texas, United States), which seems to fulfill the requirements of an ideal dressing to manage a difficult wound on heel complicated by osteomyelitis. ...
... Armstrong and Lavery reported that more patients in the NPWT group healed their wounds (defined as 100%reepithelialization with no drainage) versus the standard group. 43 Rate of healing and of granulation tissue formation was faster in the NPWT group. They found trends toward fewer second amputations. ...
... The production of robust granulation tissue during NPWT treatment has been reported in numerous clinical studies [4,27,28]. NPWT with a porous foam dressing evenly distribute vacuum to the wound, while causing microdeformation, have been referred to as microdeformation wound therapy (MDWT) [6,7]. Four primary mechanisms have been proposed: wound shrinkage or microdeformation [19,29]; microdeformation at the foamwound surface interface [30]; fluid removal [29]; and stabilization of the wound environment [19]. ...
Article
Aim: To evaluate the efficacy of negative pressure wound therapy (NPWT) combined with platelet-rich fibrin (PRF) in treating bone-exposed wounds and explore its possible mechanism. Materials & methods: A bone-exposed wound was created in a total of 32 healthy Sprague-Dawley rats, which were treated with either control, NPWT group, PRF group or both (N + P group). The bone-exposed area, skin contraction rate and granulation coverage and the level of growth factors in granulation tissue were determined on days 4, 7 and 10. Results: The N + P group showed significantly higher wound closure rate than that achieved with others respectively. Four factors were significantly higher in N + P group than in the other three groups. Conclusion: Combination of NPWT and PRF can repair bone-exposed wounds effectively and accelerate wound healing.
... Negative pressure wound therapy (NPWT) has been shown to improve healing outcomes for patients with diabetes • diabetic foot wounds • home therapy • leg wounds • limb salvage • mechanical negative pressure wound therapy • NPWT • outcomes • ulcers • wound • wound care • wound healing DFUs by promoting the formation of granulation tissue and removing excess fluid from open wounds. [4][5][6][7] However, these devices are often bulky, noisy and inconvenient to carry around. ...
Article
Objective Mechanical negative pressure wound therapy is an ultraportable, light weight and disposable single-use device that has been shown to promote wound healing. This study evaluated home use of a mechanically powered negative pressure wound therapy (NPWT) in diabetic foot wounds. Methods Patients underwent revascularisation and/or debridement or amputation before starting mechanical NPWT. Wound outcomes and images of the wounds were recorded at each follow-up visit by the wound nurse. Patients were followed up until wound closure or end of therapy. Results A total of 12 patients (each with one wound) were included in the study. Of the 12 wounds, 33.3% (n=4) of wounds achieved primary wound closure while the remaining 66.6% (n=8) of wounds demonstrated a mean wound size reduction of 37.5±0.13%. Of the closed wounds, mean time to healing was 4.75±2.50 weeks. There was 100% limb salvage with no further debridement or amputations, and no 30-day unplanned readmissions. Mean length of hospital stay before starting home NPWT was 9.75±6.31 days. Mean number of NPWT changes was 8.33±2.67 sessions, while mean duration of therapy was 4.0±1.54 weeks. Mean cost of home NWPT therapy was US$1904±731 per patient. Conclusion The home use of mechanically powered NPWT in diabetic foot wounds demonstrated excellent wound healing rates and 100% limb salvage, with no complications.
Article
IntroductionDespite advances made in diagnosing and controlling diabetes mellitus (DM), treatment of diabetic foot ulcers (DFUs) is still among challenges faced by physicians. Negative pressure wound therapy (NPWT) is one of newer modalities proposed in the treatment of DFUs. However, there is lack of evidence to support its mileage in this regard. This study was conducted with the aim of assessing the efficacy of NPWT in healing process of DFUs.Materials and methodsSixty patients with DM were randomly allocated into two groups consisting of 30 patients each: the intervention group received sub-atmospheric pressure of − 75 to − 100 mmHg (5 min on, 2 min off) with dressings changed every 48 h, and the control group was treated with silver sulfadiazine dressings, changed twice daily. Patients were followed up until complete closure of ulcers, with a mean duration of 3 months.ResultsOf the total 60 patients, 27 patients (45%) were females. Most of the patients in both groups had DFUs of grade 2 according to Wegner’s classification. Rate of healing of the ulcers was significantly higher by using NPWT (p-value 0.01). NPWT also caused a significant reduction in ulcer surface area, depth, size, major and minor amputations, and disability duration (p-values 0.008, 0.002, 0.02, 0.03, and 0.01, respectively). No significant decrease in occurrence of complications was seen with NPWT.ConclusionNPWT seems to be more efficacious than conventional dressing in treating infected DFUs.
Article
Case: We present a clinical case and technique guide demonstrating the use and effectiveness of a novel, low-cost negative pressure wound therapy (NPWT) device to achieve soft-tissue coverage in a 34-year-old patient with failed rotational flap and Masquelet technique on infected tibial nonunion. Local debridement was executed, NPWT initiated, and treatment culminated with complete wound healing. Conclusion: The "Turtle VAC" offers an effective low-cost alternative to commercially vacuum-assisted closure systems for post-traumatic wounds in low-resource setting of Haiti. Its use of available equipment makes NPWT accessible and can function as a bridge to definitive closure when primary wound closure is not possible and/or between debridement procedures.
Presentation
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All surgeons and many other physicians create and treat wounds. General surgeons were once the masters of the care of both physical and, sometimes, emotional wounds. Wound care requires an understanding of normal wound healing, causes of delays of wound healing, and the management of wounds. Every wound must be treated in regard to cause, chronicity, location and level of microbial contamination, as well as critical patient factors that greatly affect wound healing, such as age, immunosuppression, nutrition, off-loading and eradication of infection....
Article
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The concepts of wound bed preparation and T.I.M.E are discussed. This article is the first of a series of four and deals with the 'T' of tissue is the T.I.M.E acronym
Article
Objective Recent literature has shown that negative pressure wound therapy with instillation and dwell time (NPWTi-d) is a valid method of managing complex wounds and gained increasingly wider interest due in part to the increasing complexity of wounds. The purpose of this case study was to obtain information on the profile of NPWTi-d in necrotizing fasciitis patients, investigate the role it play in wound bed preparation, length of hospital stay and number of debridement operations. Methods NPWTi-d has been used in patients with necrotizing fasciitis with either normal saline or Prontosan® solution and complete the treatment were involved in the present study. Following aggressive surgical debridement, NPWTi-d was initiated by instilling solution with a set dwell time of 5-10 minutes, followed by continuous NPWT of -125 mm Hg for 3-5 hours. The system was changed on a 3 to 5 days schedule until sufficient granulation tissue was evident. Patients received systemic antibiotics and underwent wound debridement as indicated. Data of wound bed preparation, length of hospital stay, duration of NPWTi-d therapy, number of surgical interventions were collected retrospectively from patient medical records. Results A total of 32 patients with diagnosis of necrotizing fasciitis received NPWTi-d were included. Granulation tissue was found to be sufficient in 9 to 16 days. The mean duration of NPWTi-d therapy was 12.5 days prior to wound closure by split-thickness autograft (n = 21), suture (n = 9), or flap transplantation (n = 2).Patients received NPWTi-d treatment over a period of 8 to 16 days. The mean length of hospitalization was 22.8 days. All wounds were successfully closed and no recurrence of infection or adverse event was observed during NPWTi-d treatment. Conclusion In these patients, NPWTi-d facilitates wound cleansing and wound bed preparation and offers the clinician an additional tool for the management of necrotizing fasciitis. Further well designed prospective investigations with low risk of bias are needed to confirm these findings in the future work.
Article
Negative pressure wound therapy (NPWT) is an established adjunctive modality for treatment of both acute and chronic wounds. However, little is known about the optimal settings and combination of treatment parameters and importantly, how these translate to target tissue strains and stresses that would result the fastest healing and buildup of good-quality tissues. Here we have used a three-dimensional open wound computational (finite element) model that contains viscoelastic skin, adipose and skeletal muscle tissue components for determining the states of tissue strains and stresses in and around the wound when subjected to NPWT with foam dressings of varying stiffnesses. We found that the skin strain state is considerably more sensitive to the pressure level than to the stiffness of the foam dressing within a 8.25 to 99 kPa range which covers the current industry standard. Accordingly, peri-wound skin strains and stresses which stimulate cell proliferation/migration and angiogenesis and thereby, healing of the wound, can be more effectively controlled by adjusting the pressure level than by varying the stiffness of the foam dressing.
Article
Diabetic Foot Infection (DFI), in its severest form the acute infected ‘diabetic foot attack’, is a limb and life threatening condition if untreated. Acute infection may lead to tissue necrosis and rapid spread through tissue planes, in the patient with poorly controlled diabetes facilitated by the host status. A combination of soft tissue infection and osteomyelitis may co-exist, in particular if chronic osteomyelitis serves as a persistent source for recurrence of soft tissue infection. This “diabetic foot attack” is characterised by acutely spreading infection and substantial soft tissue necrosis. In the presence of ulceration, the condition is classified by the Infectious Diseases Society of America/International Working Group on the Diabetic Foot (IDSA/IWGDF Class 3 or 4) presentation requiring an urgent surgical intervention by radical debridement of the infection. Thus, ‘time is tissue’, referring to tissue salvage and maximal limb preservation. Emergent treatment is important for limb salvage and may be life-saving. We provide a narrative current treatment practices in managing severe DFI with severe soft tissue and osseous infection. We address the role of surgery and its adjuvants, the long term outcomes, potential complications and possible future treatment strategies.
Article
Interstitial fluid (ISF) is considered an underutilized source of biomarkers for disease diagnosis and monitoring. However, biomacromolecular markers can not be enriched in ISF due to the restriction of capillary walls, which limits the wide use of ISF in biomarkers analysis. Here, an integrated micro-extracting system (MES) that includes a multimicrochannel microneedles (MMNs) array and a bilayer suction cup is presented. The system coupled with negative pressure (NP) realizes high-efficiency extraction of ISF and in-situ recruitment of biomacromolecular markers in a minimally invasive manner. By high-precision laser microfabrication technology, internal microchannels are created through pyramidal microneedles (MNs), which convey a concentrated, safe NP around the local dermal capillaries to increase their filtration and permeability, realizing the enrichment of biomacromolecular markers in ISF; meanwhile, the excellent mechanical properties of MMNs promise stable outlets for ISF under NP, achieving high-efficiency extraction. More importantly, compared to the lasting damage caused by applying NP directly to the skin surface, skin tissue is well-tolerated to our MES. The biomacromolecular enriching effect is confirmed by fluorescent substances with different molecular weights in vivo and bone turnover markers in osteoporosis mice model. The system broadens the vision of MN-based microdevices for minimally invasive disease diagnosis and prognosis.
Article
Background: Negative pressure wound therapy (NPWT) has been established over years for treatment of chronic and complex wounds. Objective: Aim of this study was to investigate the effect NPWT on the microperfusion. Methods: Prospective single centre analysis of patients treated with NPWT due to acute (ACUTE) wounds after fasciotomy or patients with chronic wounds (CHRONIC) due to a chronic limb threatening ischemia was performed. NPWT was conducted through a three days sequence with a negative pressure of -120 mmHg. Before after and during the entire period of therapy the microperfusion was assessed (O2C™, LEA Medizintechnik). Results: Comparison of the perfusion values of 28 patients (CHRONIC/ACUTE 5/23, women/men 8/20) before and after the NPWT sequence showed a non-significant improvement in the CHRONIC group (supine position: p = 0.144, elevated position p = 0.068) and a significant decrease in the ACUTE group (supine position p = 0.012, elevated position p = 0.034). This effect could also been demonstrated during the NPWT over time (CHRONIC: supine position: p = 0.320, elevated position: p = 0.053, ACUTE: supine position: p = 0.021, elevated position: p = 0.012). Conclusion: Microperfusion measurements showed alterations and differences in wound bed perfusion of acute and chronic wounds; acute wounds tended to a decrease of blood flow, whereas this effect was not seen in chronic wounds in peripheral artery disease.
Article
The purpose of this study is to demonstrate the capabilities of finite-element (FE) models to predict contraction of wounds managed with negative pressure wound therapy (NPWT). The features of wounds and surrounding tissues were analysed to gain insights into the mechanical effects of NPWT on them. 3D digital image correlation (DIC) measurement of soft tissue phantoms was used to investigate the effect of wound thickness, size, and shape, which were further compared with results of FE simulations. It was noticed that with an increased NP level the difference between DIC and FE in wound contraction became more pronounced, particularly for the thick wounds. In addition, the locations of the wounds were evaluated to predict their contraction characteristics, based on surrounding tissue structures, in 3D using the developed FE models. It was demonstrated that features and location of wounds influenced their deformations differently for the same pressure levels. Overall, this study, involving a combined experimental and computational approach, allowed the important insights into mechanical effects of NPWT.
Article
Two types of single-use negative-pressure wound therapy systems are currently available to treat surgical wounds: Canister-based and canisterless. This work was aimed to evaluate the performance of a canister-based vs a canisterless system, each with a different negative-pressure setting and technology for fluid management. Continuous delivery of a specified level of negative pressure to the wound bed is hypothesised to be important for promoting surgical wound healing, by achieving continuous reduction of lateral tension in the wound, particularly through decrease of skin stress concentrations around suture insertion sites. To test the above hypothesis, we developed a computational modelling framework, a laboratory bench-test for simulated clinical use and had further conducted a pre-clinical study in a porcine model for closed incision. We specifically focussed on the impact of effective fluid management for continuous delivery of a stable, consistent negative pressure and the consequences of potential losses of the pressure level over the therapy period. We found that a greater (absolute) negative-pressure level and its continuous, consistent delivery through controlled fluid management technology, by removing excess fluid from the dressing, provides far superior biomechanical performances. These conditions are more likely to result in better quality of the repaired tissues.
Article
Background The risk of wound related complications, including surgical site infections (SSIs), in patients undergoing surgery for metastatic spine disease (MSD) is high. Consequently, patients requiring wound revision surgery face delay in resuming oncological care and incur additional hospitalization. Recent reports suggest that negative pressure wound therapy (NPWT) applied on a closed wound at the time of surgery, significantly reduces post-operative wound complications in degenerative spine disease and trauma setting. Here, we report a single institution experience with incisional NPWT in patients undergoing surgery for MSD. Methods We compared rates of wound complications requiring surgical revision in a surgical cohort of patients with or without NPWT from 2015 to 2020. Adult patients with radiographic evidence of MSD with mechanical instability and/or accelerated neurological decline were included in the study. NPWT was applied on a closed wound in the operating room and continued for 5 days or until discharge, whichever occurred first. Results A total of 42 patients were included: 28 with NPWT and 14 without. Patient demographics including underlying comorbidities were largely similar. NPWT patients had higher rates of prior radiation to the surgical site (36% vs. 0%, p = 0.017) and longer fusion constructs (6.7 vs. 3.9 levels, p < 0.001). Three patients (21%) from control group and none from NPWT group contracted SSI requiring wound washout (p = 0.032). Conclusions Our data suggests that SSI and wound dehiscence are significantly reduced with the addition of incisional NPWT in in this vulnerable population.
Thesis
Mit steigender Lebenserwartung und dem demographischen Wandel kommt es zu einer Zunahme von multimorbiden Patienten mit chronischen Wunden. Am häufigsten sind chronische Wunden am Unterschenkel lokalisiert. Es handelt sich um komplexe Wunden, welche eine hohe mikrobielle Kontamination aufweisen. Die Therapie eines chronischen Ulcus cruris ist langfristig und oftmals frustran. Der Einsatz und die Weiterentwicklung der Vakuumversiegelungstherapie stellen hierbei einen großen Fortschritt dar. Die Vakuumversiegelung ermöglicht eine effektive Therapie einer Vielzahl von Wunden. Hierzu zählen nicht nur chronische Wunden, sondern auch akute und stark kontaminierte Wunden, sowie Verbrennungen. Die Vakuumtherapie, auch als negative-pressure wound therapy (NPWT) bezeichnet, eignet sich ebenfalls zur Wundkonditionierung vor plastischer Rekonstruktion. Es besteht die Möglichkeit, die Unterdrucktherapie sowohl in ursprünglicher Form ohne Instillation (NPWT), als auch kombiniert mit Instillation (NPWTi-d) durchzuführen. Die Studie vergleicht beide Formen. Ebenfalls von Interesse ist der Einfluss der Unterdrucktherapie auf die Keimbelastung der Wunden. Zudem wird das Patientenkollektiv mit seinen Kofaktoren, Komorbiditäten, als auch die Effektivität der Behandlung bei multiresistenten Keimen untersucht.
Article
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This study aimed to systematically review the current literature on studies using negative pressure wound therapy (NPWT) or dressings following fracture-related infection (FRI) in internal osteosynthesis of the extremity. Articles were analyzed on fracture and wound healing and included when comparing or describing the use of either NPWT or dressings in FRI. We conducted a systematic literature search in four electronic databases: Embase, Medline, the Cochrane Library, and Scopus. The studies were screened by two authors using Covidence.org and evaluated for risk of bias. A total of 8576 records were identified. No articles compared NPWT to dressings. Seven case reports and three case series included a total of 115 patients treated for FRI. Fracture healing was achieved in 21 out of 67 patients treated with NPWT (4 amputations and 46 not described) and all 48 patients in the dressing group (4 patients needed additional sequestrectomy procedures). Five studies did not describe fracture healing. In 57 out of 67 patients treated with NPWT, the wounds were described as healed, closed, or requiring soft tissue reconstruction (4 amputations and six lacking description). The dressing group had complete wound coverage in 18 patients and partial coverage in 30 patients. Studies were generally at high risk of bias because of insufficient descriptions of both patient demographics and outcomes. No studies compared NPWT to dressings, and the existing literature is at high risk of bias. The included studies were of low-level evidence. NPWT can be neither recommended nor advised against to cover infected osteosynthesis.
Article
The difficulty of wound healing in patients with diabetes mellitus remains a considerable challenge for clinical and scientific research. To address the problem of poor healing that affects chronic wounds in patients with diabetes, we developed an injectable self-healing hydrogel based on chitosan (CS), hyaluronic acid (HA), and kalium γ-cyclodextrin metal organic frameworks (K-γ-CD-MOFs) loaded α-lipoic acid (α-LA) with antibacterial activity and antioxidant performance. In vitro analysis showed that the hydrogel could promote cell proliferation and migration on the basis of Cell Counting Kit-8 (CCK-8) assay and Transwell experiments. Moreover, the addition of α-LA allowed the reversal of oxidative stress-induced cell damage. In vivo analyses were performed involving a full-thickness wound model in diabetic Sprague–Dawley (SD) rats. The hydrogel dressing significantly promoted the wound healing process with better granulation tissue formation and more collagen deposition because of its multifunctional traits, suggesting that it can be an excellent treatment for chronic full-thickness skin wound healing.
Chapter
Wound repair and regeneration of structurally and functionally active tissues is extremely challenging and comprise of one of the major developing sectors in the healthcare industry. Under normal circumstances wound healing proceeds through the four overlapping phases of hemostasis, inflammation, proliferation, and remodeling; however, for chronic cases, the healing stalls owing to the presence of repeated external stimuli and existing micro-environmental anarchy at the wound site. Persistent problems in the healing of chronic wounds lead to ulceration and, under severe circumstances results in amputation. Moreover, a study conducted by the Global Burden of Disease (GBD), combined with data collected from regional, national, and global resources in 195 countries, depicted that the global burden of chronic dermal wounds has increased significantly over the past ten years since 2005. Recent advances in wound healing studies demonstrate the use of different therapies or matrices for application in non-healing wounds. The first section of this article provides a general overview of the different types of wounds and the healing process. The second part delineates the use of various FDA and non-FDA approved, clinically used wound healing applications. The last part deals with the various devices used in the treatment of acute and chronic wounds, along with their mechanism and mode of action.
Article
Diabetic foot infection is frequent in diabetic patients and is due to neuropathy, trauma or peripheral arterial disease. The presence of an abscess requires urgent drainage and specific antibiotic therapy. Patients with critical limb ischemia need revascularization and, subsequently the intervention of a plastic surgeon is often required in cases of exposure of tendons and ligaments. During the COVID-19 pandemic, a patient was refered to our department with an abscess on the dorsum of the left foot. After urgent drainage with tendon exposure, he started specific antibiotic therapy and underwent tibial vessels angioplasty. After infection healing cord blood platelet gel was applied, accelerating the healing process, with injection of its liquid part into the exposed tendons, thus retaining the vital functions of the tendons.
Article
Negative pressure wound therapy (NPWT) promotes healing by evenly applying negative pressure on the surface of the wound. The system consists of a sponge, a semiocclusive barrier, and a fluid collection system. Its effectiveness is explained by four main mechanisms of action, including macrodeformation of the tissues, drainage of extracellular inflammatory fluids, stabilization of the environment of the wound, and microdeformation. Rarely will complications linked to NPWT occur, but special care must be taken to prevent events such as toxic shock syndrome, fistulization, bleeding, and pain. New NPWT modalities have been recently developed to make NPWT suitable for a wider variety of wounds. These include NPWT with instillation therapy (NPWTi-d), different cleansing options, and application of NPWT on primarily closed incisions. Finally, vacuum-assisted wound closure therapy has been demonstrated to be efficient for various clinical settings, such as the management of diabetic foot ulcers, pressure ulcerations, chronic wounds, and skin grafts.
Article
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Background: Negative pressure wound therapy (NPWT) has shown remarkable adaptation in wound management worldwide. Numerous studies have provided evidence that demonstrates both the medical and financial advantages of NPWT. In this study, the VAC Therapy System, one of the leading commercially used NPWT systems, has been utilized to treat patients with either acute or chronic wounds requiring surgical intervention, with the aim of demonstrating the efficacy of using a modified version of the VAC system while reducing the total associated cost. Method: The patients were divided into two randomly selected groups using randomization generator software. A modification was made by replacing the disposable canister provided by Kinetic Concepts Inc., with an alternative reusable canister (Baxter, Inc.); one group was assigned to use the conventional VAC Therapy System, and the other was assigned to use the modified version. Our study aimed to investigate whether this modification would lower the cost of the VAC Therapy System while still achieving the desired outcome. Results: The VAC Therapy System contributed to improving the wound bed score in both groups, which supports previous findings on the effectiveness of NPWT while reflecting that the modification did not negatively impact the functionality and the integrity of the VAC Therapy System. Furthermore, the average daily consumables cost was markedly reduced in the modified group compared with the standard group, which reduced the overall cost of treatment. Conclusion: It is possible to use the VAC Therapy System to its full advantage, while minimizing the financial burden of using it.
Article
Background Management of patients with diabetic foot ulcer is often burdensome, complex, and arduous. In addition, it can be challenging for clinicians and researchers to understand the surgical management of diabetic foot ulcer from the existing studies because of the extensive literature on this topic. Methods Bibliometric analysis was conducted using CiteSpace, and data were retrieved from the Web of Science Core Collection. Results A total of 1,475 publications were retrieved. The “United States Department of Health and Human Services (HHS, USA)” and “National Institutes of Health (NIH, USA)” were the most important funders. The most active authors were Armstrong DG and Lipsky BA. The most active institutions were the University of Washington and University of Arizona. Developed countries in the USA and England contributed the most to the literature, and the publications were clustered into 15 topics. The emerging topic trend was the cluster label for “diabetic foot osteomyelitis” and “multidisciplinary setting”. Conclusions This study provides researchers and clinicians with important information on the cooperation of authors, institutions, and countries, intellectual structure, knowledge flow, and emerging topic trend, to help them with their subject cognition, study visits, study abroad, research direction selection, and grant applications.
Chapter
This chapter is complementary to Chapters 19 and 20. The authors focus on the clinical presentation of the Charcot neuroarthropathic foot (diabetic foot) and the conservative and surgical management of this diabetes-induced complication. They provide details regarding the physical examination of the affected foot and how to recognize the condition at its early stage and beyond. There is an elaborated section on the conservative management of the Charcot diabetic. The indications and criteria for surgical management—including amputation—are clearly elucidated based on changes detected in the three components of the ankle-foot unit. The surgical techniques for the infected foot and the deformed are described with a note on the prognosis of the surgical approach. Future nonoperative developments and surgical techniques are discussed.
Article
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The aim of this study was to determine the top-cited articles in the field of diabetic foot ulcer (DFU) research. A cross-sectional bibliometric analysis was conducted in January 2021 by using Boolean search terms in the Scopus and the Web of Science databases. The 50 top-cited articles that met the inclusion criteria were ranked and evaluated for several characteristics, including year of publication, country of origin, authorship, publishing journal, topic categories, publishing type, and level of evidence. The median number of citations per article in the list was 442 (interquartile range [IQR], 320-520), with a median of 21.8 citations (IQR, 16.5-34.5) per year since publication. The publication years ranged from 1986 to 2017, with 1998 accounting for the greatest number of studies ( n = 7). The citation classics were published in 20 journals and originated from institutions in 9 countries. The majority of the studies were clinical, of which expert opinion/review with Level V evidence and clinical studies with Levels I and II evidence comprised the greater proportion in the list. This study provides useful insights into the history and development of DFU research. The top-cited list may serve as a quick reference for education curriculums and clinical practice, in addition to providing a foundation for further studies on this topic.
Article
In consultation with academia and the Pharmaceuticals and Medical Devices Agency (PMDA), we have developed guidance for drafting protocols for clinical trials concerning medical devices for the healing of hard-to-heal wounds without ischaemia. The guidance summarises the validity of single-arm trials for hard-to-heal wounds, the definition of hard-to-heal wounds without ischaemia, methods of patient enrolment and clinical endpoints. This review focuses on the logical thinking process that was used when establishing the guidance for improving the efficiency of clinical trials concerning medical devices for hard-to-heal wounds. We particularly focused on the feasibility of conducting single-arm trials and also tried to clarify the definition of hard-to-heal wounds. If the feasibility of randomised control trials is low, conducting single-arm trials should be considered for the benefit of patients. In addition, hard-to-heal wounds were defined as meeting the following two conditions: wounds with a wound area reduction <50% at four weeks despite appropriate standards of care; and wounds which cannot be closed by a relatively simple procedure (for example, suture, skin graft and small flaps). Medical devices for hard-to-heal wound healing are classified into two types: (1) devices for promoting re-epithelialisation; and (2) devices for improving the wound bed. For medical devices for promoting re-epithelialisation, we suggest setting complete wound closure, percent wound area reduction or distance moved by the wound edge as the primary endpoint in single-arm trials for hard-to-heal wounds. For medical devices for improving the wound bed, we suggest setting the period in which wounds can be closed by secondary intention or a simple procedure, such as the primary endpoint.
Article
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Context: Among persons diagnosed as having diabetes mellitus, the prevalence of foot ulcers is 4% to 10%, the annual population-based incidence is 1.0% to 4.1%, and the lifetime incidence may be as high as 25%. These ulcers frequently become infected, cause great morbidity, engender considerable financial costs, and are the usual first step to lower extremity amputation. Objective: To systematically review the evidence on the efficacy of methods advocated for preventing diabetic foot ulcers in the primary care setting. Data sources, study selection, and data extraction: The EBSCO, MEDLINE, and the National Guideline Clearinghouse databases were searched for articles published between January 1980 and April 2004 using database-specific keywords. Bibliographies of retrieved articles were also searched, along with the Cochrane Library and relevant Web sites. We reviewed the retrieved literature for pertinent information, paying particular attention to prospective cohort studies and randomized clinical trials. Data synthesis: Prevention of diabetic foot ulcers begins with screening for loss of protective sensation, which is best accomplished in the primary care setting with a brief history and the Semmes-Weinstein monofilament. Specialist clinics may quantify neuropathy with biothesiometry, measure plantar foot pressure, and assess lower extremity vascular status with Doppler ultrasound and ankle-brachial blood pressure indices. These measurements, in conjunction with other findings from the history and physical examination, enable clinicians to stratify patients based on risk and to determine the type of intervention. Educating patients about proper foot care and periodic foot examinations are effective interventions to prevent ulceration. Other possibly effective clinical interventions include optimizing glycemic control, smoking cessation, intensive podiatric care, debridement of calluses, and certain types of prophylactic foot surgery. The value of various types of prescription footwear for ulcer prevention is not clear. Conclusions: Substantial evidence supports screening all patients with diabetes to identify those at risk for foot ulceration. These patients might benefit from certain prophylactic interventions, including patient education, prescription footwear, intensive podiatric care, and evaluation for surgical interventions.
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Recent trends in amputation surgery favor amputation at the most distal level to preserve the patient's ability to walk. This paper reports the results of sixty-four amputations performed at the level of the middle of the foot in fifty-eight patients. All were performed in patients with peripheral vascular disease who had a diagnosis of either gangrene or resistant, nonhealing ulcers. Forty-three patients (74 per cent) had diabetes. Nutritional evaluation of the patient was used to improve the potential for healing. In the initial forty-six patients, a retrospective review of the serum albumin level, the blood total-lymphocyte count, and the Doppler ischemic index was performed. A prospective study was performed in the final twelve patients, in whom a minimum level in each of these three factors was required before the distal amputation was done. The healing rate for all sixty-four amputations was 81 per cent. When all three factors were above the minimum level, the healing rate was increased to 92.2 per cent. When one or two of the factors was below the minimum level, the rate of healing decreased to 38.5 per cent. Aggressive distal amputation can be performed with a high rate of success when the factors influencing the decision on the amputation level include non-invasive vascular testing and nutritional evaluation.
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To assess the ability of vibration perception threshold (VPT) to predict the development of diabetic foot ulceration. A prospective follow-up study of consecutive patients with vibration perception measured by biothesiometry from April 1988 to March 1989. Patients were stratified in various risk groups. Patients with a VPT < 15 V had a cumulative incidence of foot ulceration of 2.9% compared with 19.8% in patients with a VPT > 25 V, odds ratio (OR) 7.99 (3.65-17.5, 95% confidence intervals), P < 0.01. The incidence of ulceration increased with duration of diabetes, but even with this effect removed, the excess of ulceration persisted, OR 6.82 (2.75-16.92), P < 0.01. VPT is an effective predictor of the risk of foot ulceration in diabetes and therefore could be used to target foot-care education to those patients most likely to benefit and, thereby, possibly improve its effectiveness.
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To compare the effectiveness of total contact casts, commercially available therapeutic shoes, and removable walking casts to reduce mean peak plantar foot pressures at the site of neuropathic ulcerations in diabetic subjects. We compared the reduction in peak plantar pressures at ulcer sites under the great toe (n = 5), first metatarsal (n = 10), and second through fifth metatarsals (n = 10) using six treatments: total contact casts (TCCs), DH Pressure Relief Walkers (DH), Aircast Pneumatic Walkers, Three D Dura-Steppers (3D), CAM Walkers, and P.W. Minor Xtra Depth shoes. A rubber sole canvas oxford was used to establish baseline pressure values. The canvas oxford could be viewed as a worse-case scenario for this patient population. With the EMED Pedar in-shoe pressure measurement system, data for 40 steps were collected for each treatment. We used Tukey's Studentized Range Test for simultaneous multiple comparisons to compare treatments. DH Pressure Relief Walkers reduced plantar pressures significantly better than other commercially available treatments for ulcers under the first metatarsal, second through fifth metatarsals, and great toe (P < 0.05). There was not a significant difference in mean peak plantar pressures between TCCs and DHs at any of the forefoot ulcer sites. DH Pressure Relief Walkers were as effective as total contact casts to reduce foot pressures at ulcer sites and may be an effective practical addition in the treatment of foot ulcers.
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To evaluate the sensitivity and specificity of 3 sensory perception testing instruments to screen for risk of diabetic foot ulceration. This case-control study prospectively measured the degree of peripheral sensory neuropathy in diabetic patients with and without foot ulcers. We enrolled 115 age-matched diabetic patients (40% male) with a case-control ratio of approximately 1:3 (30 cases and 85 controls) from a tertiary care diabetic foot specialty clinic. Cases were defined as individuals who had an existing foot ulceration or a history of a recently (< 4 weeks) healed foot ulceration. Controls were defined as subjects with no foot ulceration history. Using receiver operating characteristic analysis, we evaluated the sensitivity and specificity of 2 commonly used nephropathy assessment tools (vibration perception threshold testing and the Semmes-Weinstein 10-g monofilament wire system) and a 4-question verbal neuropathy score to evaluate for presence of foot ulceration. A vibration perception threshold testing using 25 V and lack of perception at 4 or more sites using the Semmes-Weinstein 10-g monofilament wire system had a significantly higher specificity than neuropathy score used. The neuropathy score was most sensitive when 1 or more answers were affirmative. When modalities were combined, particularly the monofilament wire system plus vibration perception threshold testing and the neuropathy score plus the monofilament wire system, there was a substantial increase in specificity with little or no diminution in sensitivity. The early detection of peripheral neuropathy or loss of "protective sensation" is paramount to instituting a structured treatment plan to prevent lower extremity amputation. The results of our study suggest that all 3 sensory perception testing instruments are sensitive in identifying patients at risk for ulceration. Combining modalities appears to increase specificity with very little or no diminution in sensitivity.
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In this prospective study, mortality, rehabilitation, and new amputations on the same or on the contralateral leg were studied in 189 patients with diabetes who had achieved healing of an index amputation. Ninety-three patients had achieved healing after an index minor (below the ankle) and 96 after an index major (above the ankle) amputation, precipitated by a foot ulcer. The healing time was 29 weeks (range, 3-191 weeks) with a minor amputation and 8 weeks (range, 3-104 weeks) with a primary major amputation. The mortality 1, 3, and 5 years after the index amputation was 15%, 38%, and 68%, respectively, and was higher in patients who had achieved healing after major amputation than in patients achieving healing after minor amputation. The rate of new amputations after 1, 3, and 5 years of observation was 14%, 30%, and 49%, respectively. There was no difference among patients with an index minor and those with an index major amputation. The rate of new major amputations was 9%, 13%, and 23%, respectively, and was higher in patients with an index major amputation. Eighty-five percent of new amputations were precipitated by a foot ulcer. Patients living independently before the index amputation returned to living independently more often after a minor than a major amputation (93% versus 61%). One year after the index amputation, 70% of patients who had achieved healing after having a minor amputation and who could walk 1 km or more before amputation had regained this walking capacity, compared with 19% of patients having a major amputation. Seventy percent of patients with an index transtibial amputation who could walk before amputation were fitted with a prosthesis, and 52% were using it regularly. Patients with diabetes who had an index major amputation had a higher mortality, an equal rate of new amputation, and a lower rehabilitation potential than did patients who had an index minor amputation.
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We assessed in a randomized prospective trial the effectiveness of Graftskin, a living skin equivalent, in treating noninfected nonischemic chronic plantar diabetic foot ulcers. In 24 centers in the U.S., 208 patients were randomly assigned to ulcer treatment either with Graftskin (112 patients) or saline-moistened gauze (96 patients, control group). Standard state-of-the-art adjunctive therapy, which included extensive surgical debridement and adequate foot off-loading, was provided in both groups. Graftskin was applied at the beginning of the study and weekly thereafter for a maximum of 4 weeks (maximum of five applications) or earlier if complete healing occurred. The major outcome of complete wound healing was assessed by intention to treat at the 12-week follow-up visit. At the 12-week follow-up visit, 63 (56%) Graftskin-treated patients achieved complete wound healing compared with 36 (38%) in the control group (P = 0.0042). The Kaplan-Meier median time to complete closure was 65 days for Graftskin, significantly lower than the 90 days observed in the control group (P = 0.0026). The odds ratio for complete healing for a Graftskin-treated ulcer compared with a control-treated ulcer was 2.14 (95% CI 1.23-3.74). The rate of adverse reactions was similar between the two groups with the exception of osteomyelitis and lower-limb amputations, both of which were less frequent in the Graftskin group. Application of Graftskin for a maximum of 4 weeks results in a higher healing rate when compared with state-of-the-art currently available treatment and is not associated with any significant side effects. Graftskin may be a very useful adjunct for the management of diabetic foot ulcers that are resistant to the currently available standard of care.
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To compare the effectiveness of total-contact casts (TCCs), removable cast walkers (RCWs), and half-shoes to heal neuropathic foot ulcerations in individuals with diabetes. In this prospective clinical trial, 63 patients with superficial noninfected, nonischemic diabetic plantar foot ulcers were randomized to one of three off-loading modalities: TCC, half-shoe, or RCW. Outcomes were assessed at wound healing or at 12 weeks, whichever came first. Primary outcome measures included proportion of complete wound healing at 12 weeks and activity (defined as steps per day). The proportions of healing for patients treated with TCC, RCW, and half-shoe were 89.5, 65.0, and 58.3%, respectively. A significantly higher proportion of patients were healed by 12 weeks in the TCC group when compared with the two other modalities (89.5 vs. 61.4%, P = 0.026, odds ratio 5.4, 95% CI 1.1-26.1). There was also a significant difference in survival distribution (time to healing) between patients treated with a TCC and both an RCW (P = 0.033) and half-shoe (P = 0.012). Patients were significantly less active in the TCC (600.1 +/- 320.0 daily steps) compared with the half-shoe (1,461.8 +/- 1,452.3 daily steps, P = 0.04). There was no significant difference in the average number of steps between the TCC and the RCW (767.6 +/- 563.3 daily steps, P = 0.67) or the RCW and the half-shoe (P = 0.15). The TCC seems to heal a higher proportion of wounds in a shorter amount of time than two other widely used off-loading modalities, the RCW and the half-shoe.
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To report the incidence of diabetes-related lower-extremity complications in a cohort of patients enrolled in a diabetes disease management program. We evaluated screening results and clinical outcomes for the first 1,666 patients enrolled in a disease management program for a period of 24 months (50.3% men, aged 69.1 +/- 11.1 years). The incidence of ulceration, infection, amputation, and lower-extremity bypass was 68.4, 36.5, 5.9, and 7.7 per 1,000 persons with diabetes per year. Amputation incidence was higher in Mexican Americans than in non-Hispanic whites (7.4/1,000 vs. 4.1/1,000; P = 0.003, odds ratio [OR] 1.8, 95% CI 1.2-2.7). The amputation-to-ulcer ratio was 8.7%. The incidence of Charcot arthropathy was 8.5/1,000 per year. Charcot was more common in non-Hispanic whites than in Mexican Americans (11.7/1,000 vs. 6.4/1,000; P = 0.0001, 1.8, 1.3-2.5). The prevalence of peripheral vascular disease was 13.5%, with no significant difference based on ethnicity (P = 0.3). There was not a significant difference in incidence of foot infection (P = 0.9), lower-extremity bypass (P = 0.3), or ulceration (P = 0.1) based on ethnicity. However, there were more failed bypasses in Mexican Americans (33%) than in non-Hispanic whites (7.1%). Mexican Americans were 3.8 times more likely to have a failed bypass (leading to an amputation) or be diagnosed as "nonbypassable" than non-Hispanic whites (75.0 vs. 44.0%; P = 0.01, 3.8, 1.2-11.8). The incidence of amputation is higher in Mexican Americans, despite rates of ulceration, infection, vascular disease, and lower-extremity bypass similar to those of non-Hispanic whites. There may be factors associated with failed or failure to bypass that mandate further investigation.
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The basic etiology of neuropathic diabetic foot wounds involves pressure in conjunction with cycles of repetitive stress, leading to failure of skin and soft tissue. The central tenet of any treatment plan addressing neuropathic diabetic foot wounds is the appropriate debridement of nonviable tissue coupled with adequate pressure relief (off-loading). Although numerous advances have been made in the treatment of diabetic foot wounds, including bioengineered tissues, autologous and exogenous cytokine delivery systems, and potentially effective topical antimicrobial modalities, none will succeed without addressing effective debridement and off-loading. Specific debridement and off-loading techniques are discussed, along with available supporting evidence. This includes the use of the “instant” total contact cast, among other modalities.
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The purpose of this study was to compare the effectiveness of a removable cast walker (RCW) rendered irremovable (iTCC) with the total contact cast (TCC) in the treatment of diabetic neuropathic plantar foot ulcers. In a prospective, randomized, controlled trial, 41 consecutive diabetic patients with chronic, nonischemic, neuropathic plantar foot ulcers were randomly assigned to one of two groups: a RCW rendered irremovable by wrapping it with a single layer of fiberglass casting material (i.e., an iTCC) or a standard TCC. Primary outcome measures were the proportion of patients with ulcers that healed at </=12 weeks, healing rates, complication rates, cast placement/removal times, and costs. The proportions of patients with ulcers that healed within 12 weeks in the iTCC and TCC groups were 80 and 74%, respectively (94 and 93%, respectively, when patients who were lost to follow-up were excluded). Survival analysis (healing rates) was statistically equivalent in the two groups, as were complication rates, but with a trend toward benefit in the iTCC group. The iTCC took significantly less time to place and remove than the TCC with 39% and 36% reductions, respectively. There was also an overall lower cost associated with the use of the iTCC compared with the TCC. The iTCC may be equally efficacious, faster to place, easier to use, and less expensive than the TCC in the treatment of diabetic plantar neuropathic foot ulcers.
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The purpose of this study was to evaluate the effectiveness of a removable cast walker (RCW) and an "instant" total contact cast (iTCC) in healing neuropathic diabetic foot ulcerations. We randomly assigned 50 patients with University of Texas grade 1A diabetic foot ulcerations into one of two off-loading treatment groups: an RCW or the same RCW wrapped with a cohesive bandage (iTCC) so patients could not easily remove the device. Subjects were evaluated weekly for 12 weeks or until wound healing. An intent-to-treat analysis showed that a higher proportion of patients had ulcers that were healed at 12 weeks in the iTCC group than in the RCW group (82.6 vs. 51.9%, P = 0.02, odds ratio 1.8 [95% CI 1.1-2.9]). Of the patients with ulcers that healed, those treated with an iTCC healed significantly sooner (41.6 +/- 18.7 vs. 58.0 +/- 15.2 days, P = 0.02). Modification of a standard RCW to increase patient adherence to pressure off-loading may increase both the proportion of ulcers that heal and the rate of healing of diabetic neuropathic wounds.
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In clinical practice many wounds are slow to heal and difficult to manage. The recently introduced technique of topical negative pressure therapy (TNP) has been developed to try to overcome some of these difficulties. TNP applies a controlled negative pressure to the surface of a wound that has potential advantages for wound treatment and management. Although the concept itself, of using suction in wound management is not new, the technique of applying a negative pressure at the surface of the wound is. This paper explores the origins and proposed mechanisms of action of TNP therapy and discusses the types of wounds that are thought to benefit most from use of this system.
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Chronic, open, nonhealing wounds pose a continual challenge in medicine. Our objective was to evaluate vacuum-assisted closure (VAC)* therapy's ability to improve the healing rate of chronic wounds compared to the traditional saline-wet-to-moist (WM) dressings. Twenty-four patients with 36 chronic, nonhealing wounds were enrolled in the study after obtaining proper consent. Subjects were randomized to the VAC group or the control group. Biopsies and wound measurements were obtained by blinded independent wound evaluators. The most significant difference was the change in depth of 66 percent for VAC compared to 20 percent for WM (p<.00001). Histologically, the groups exhibited different characteristics. In the WM group, 81 percent (n=13) displayed inflammation and fibrosis. The chief characteristic of the VAC group was granulation tissue formation in 64 percent (n=9) of those wounds. The VAC system should be used to obtain wound closure, especially of chronic nonhealing wounds with great depth, rather than the traditional saline WM dressings.
Article
Hypothesis Promogran, a wound dressing consisting of collagen and oxidized regenerated cellulose, is more effective that standard care in treating chronic diabetic plantar ulcers.Design Randomized, prospective, controlled multicenter trial.Setting University teaching hospitals and primary care centers.Patients A total of 276 patients from 11 centers were enrolled in the study. The mean age of the patients was 58.3 years (range, 23-85 years). All patients had at least 1 diabetic foot ulcer.Interventions Patients were randomized to receive Promogran (n = 138) or moistened gauze (control group; n = 138) and a secondary dressing. Dressings were changed when clinically required. The maximum follow-up for each patient was 12 weeks.Main Outcome Measure Complete healing of the study ulcer (wound).Results After 12 weeks of treatment, 51 (37.0%) Promogran-treated patients had complete wound closure compared with 39 (28.3%) control patientss, but this difference was not statistically significant (P = .12). The difference in healing between treatment groups achieved borderline significance in the subgroup of patients with wounds of less than 6 months' duration. In patients with ulcers of less than 6 months' duration, 43 (45%) of 95 Promogran-treated patients healed compared with 29 (33%) of 89 controls (P = .056). In the group with wounds of at least 6 months' duration, similar numbers of patients healed in the control (10/49 [20%]) and the Promogran (8/43 [19%]; P = .83) groups. No differences were seen in the safety measurements between groups. Patients and investigators expressed a strong preference for Promogran compared with moistened gauze.Conclusions Promogran was comparable to moistened gauze in promoting wound healing in diabetic foot ulcers. It showed an additional efficacy for ulcers of less than 6 months' duration that was of marginal statistical significance. Furthermore, Promogran had a safety profile that was similar to that of moistened gauze, with greater user satisfaction. Therefore, Promogran may be a useful adjunct in the management of diabetic foot ulceration, especially in ulcers of less than 6 months' duration.
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To assess the outcome of transmetatarsal amputations of the foot, data were analyzed for all transmetatarsal and midfoot amputations performed at the Lebanon Veterans Health Administration Medical Center for the period 1984 to 1990. During this 6-year period, 42 consecutive transmetatarsal and midfoot amputations were performed on 39 patients. Patient demographics, factors leading to amputation, level of amputation, outcome, function, and long-term complications were analyzed. Overall healing rate was 83.3%, with an average length of hospital stay of 35.7 days (range 3 to 96 days). Average follow-up period was 30.2 months (range 2 to 65 months).
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This paper is a retrospective study of 53 male patients with peripheral neuropathy who sustained 35 partial ray resections with a 37.1% success rate, 15 transmetatarsal amputations with a success rate of 93.3%, and seven panmetatarsal head resections with a success rate of 85.7%.
Article
The purpose of this study was to investigate the efficacy and safety of recombinant human platelet-derived growth factor (rhPDGF-BB) in a double-blind, placebo-controlled, multicenter study of patients with chronic diabetic ulcers. Patients with chronic, full-thickness, lower-extremity diabetic neurotrophic ulcers of at least 8 weeks' duration, free of necrotic and infected tissue after debridement, and with transcutaneous oxygen tensions of 30 mm Hg or greater were studied. A total of 118 patients were randomized to receive either topical rhPDGF-BB (2.2 micrograms/cm2 of ulcer area) or placebo until the ulcer was completely resurfaced or for a maximum of 20 weeks, whichever occurred first. Twenty-nine (48%) of 61 patients randomized to the rhPDGF-BB group achieved complete wound healing during the study compared with only 14 (25%) of 57 patients randomized to the placebo group (p = 0.01). The median reduction in wound area in the group given rhPDGF-BB was 98.8% compared with 82.1% in the group given placebo (p = 0.09). There were no significant differences in the incidence or severity of adverse events between the rhPDGF-BB and placebo groups. Once-daily topical application of rhPDGF-BB is safe and effective in stimulating the healing of chronic, full-thickness, lower-extremity diabetic neurotrophic ulcers.
Article
To assess the effect of a tissue-engineered human dermis (Dermagraft) in healing diabetic foot ulcers. This controlled prospective multicenter randomized single-blinded pilot study evaluated healing over a 12-week period in 50 patients with diabetic foot ulcers. These patients were randomized into four groups (three different dosage regimens of Dermagraft and one control group). All patients received identical care except for the use of Dermagraft tissue. Ulcer healing was assessed by percentage of wounds achieving complete or 50% closure, time to complete or 50% closure, and volume and area measurements. Ulcers treated with the highest dosage of Dermagraft, one piece applied weekly for 8 weeks (group A), healed significantly more often than those treated with conventional wound closure methods; 50% (6 of 12) of the Dermagraft-treated and 8% (1 of 13) of the control ulcers healed completely (P = 0.03). The percentage of wounds achieving 50% closure was also significantly higher (75 vs. 23%; P = 0.018), and the time to complete or 50% closure was faster (P = 0.056). The group A regimen was more effective than other treatment regimens. All three were better than the control, however, and a dose-response was observed. There were no safety concerns. After a mean of 14 months of follow-up (range 11-22 months), there were no recurrences in the Dermagraft-healed ulcers. Dermagraft was associated with more complete and rapid healing in diabetic foot ulcers. The recurrence data may indicate an improved quality of wound healing.
Article
A prospective clinical trial from January 1994 to February 1996 evaluated the efficacy of a vacuum sealing technique in dealing with sacral pressure ulcers, acute traumatic soft tissue defects and infected soft tissue defects following rigid stabilization of lower extremity fractures in 45 patients. Polyvinyl foam under negative pressure generates an area of high contact forces at the wound/foam interface. This situation appears to facilitate granulation tissue production while maintaining a relatively clean wound bed. In 84% (38/45) of the patients the use of the vacuum sealing technique following irrigation and debridement decreased the dimensions of the initial wound, thus facilitating healing time and the eradication of any pre-existing infection. Wound closure by granulation, secondary closure, or split thickness skin grafting was achieved in 35 wounds. The vacuum sealing technique is an effective option in the management of infected wounds.
Article
A series of basic animal studies using a new subatmospheric pressure technique (The V.A.C.) to expedite wound healing are presented. The technique entails placing an open-cell foam into the wound, sealing the site with an adhesive drape, and applying subatmospheric pressure (125 mmHg below ambient) that is transmitted to the wound in a controlled manner. Utilizing a pig model, four studies were undertaken to determine the effect of subatmospheric pressure on laser Doppler-measured blood flow in the wound and adjacent tissue (N = 5), rate of granulation tissue formation (N = 10), clearance of bacteria from infected wounds (N = 5), and measurement of nutrient flow by random-pattern flap survival (N = 5). Blood flow levels increased fourfold when 125 mmHg subatmospheric pressure was applied. Significantly increased rates of granulation tissue formation (p < or = 0.05) occurred with both continuous (63.3 +/- 26.1%) and intermittent (103% +/- 35.3%) application. Tissue bacterial counts significantly decreased (p < or = 0.05) after 4 days of application. Random-pattern flap survival significantly increased (p < or = 0.05) by 21% compared to controls. We determined that the application of controlled subatmospheric pressure creates an environment that promotes would healing.
Article
The purpose of this study is to report the prevalence of reamputation following resection of the great toe and first ray in adults with diabetes. We abstracted the medical records of 90 diabetic great-toe and first-ray amputees admitted between 1981 and 1991. The most common etiologies of initial amputations were ulcer with soft tissue infection (39%), ulcer with osteomyelitis (32%), and puncture wounds (12%). Sixty percent of all patients had a second amputation, 21% had a third, and 7% had a fourth. Fifteen percent of the patients who had a second amputation had it contralaterally. Seventeen percent subsequently underwent a below-knee amputation and 11% had a Transmetatarsal amputation on the same extremity, 3% had a below-knee amputation, and 2% a transmetatarsal amputation contralaterally. The mean time from the first to the second amputation was approximately 10 months. The results of this study suggest that a large proportion of patients undergoing an amputation at the level of the great toe or first ray have subsequent amputations in the first year following the initial procedure. Additionally, it appears that the contralateral foot may be at significant risk for distal amputation following resection of the hallux or first day.
Article
Few scientific data are available on the effectiveness of commonly used modalities for reducing pressure at the site of neuropathic ulcers in persons with diabetes mellitus. The authors' aim was to compare the effectiveness of total contact casts, half-shoes, rigid-soled postoperative shoes, accommodative dressings made of felt and polyethylene foam, and removable walking casts in reducing peak plantar foot pressures at the site of neuropathic ulcerations in diabetics. Using an in-shoe pressure-measurement system, data from 32 midgait steps were collected for each treatment. There was a consistent pattern in the devices' effectiveness in reducing foot pressures at ulcer sites under the great toe and ball of the foot. Removable walking casts were as effective as or more effective than total contact casts. Half-shoes were consistently the third most effective modality, followed by accommodative dressings and rigid-soled postoperative shoes.
Article
The purpose of this study was to evaluate the reliability of digital videometry and acetate tracing in the measurement of cutaneous wound area. Four clinicians used both digital videometry and acetate tracing to measure five wounds that were artificially created on a cadaver specimen. In addition, the clinicians used an analog centimeter ruler to determine a rough estimate of the area of each wound. The wounds were measured a total of five times with each measurement instrument using a non-sequential repeat measures design. Associations between the three wound measurement techniques were examined with Pearson correlation coefficients. In addition, intraclass correlation coefficients (ICC) were calculated for each pair of the three measurement techniques. Correlation between the measurement systems for all raters combined yielded Pearson r-values of 0.93 for ruler and acetate, 0.95 for ruler and digital and 0.97 for acetate and digital. Furthermore, the average measure ICC between acetate and digital was 0.94, between acetate and ruler was 0.76 and between digital and ruler was 0.57. These results suggest that wound area measurements obtained using digital videometry and acetate tracing are very similar and both techniques can be used interchangeably in either clinical or research settings.
Article
Diabetic foot wounds present a great challenge to wound care practitioners. The objective of this pilot study was to determine whether vacuum-assisted closure (V.A.C.) therapy would afford quicker wound resolution as compared to saline-moistened gauze in the treatment of postoperative diabetic foot wounds. Ten patients were randomized into either the experimental V.A.C. group or control saline gauze group. Included in the study were diabetic patients 18 to 75 years of age who had a nonhealing foot ulceration. Excluded were those patients with venous disease, coagulopathy, or those who had active infections not resolved by initial surgical debridement. All foot ulcers were surgically debrided prior to initiation of V.A.C. or gauze treatment. In the experimental group, V.A.C. dressings were applied in accordance with manufacturer's protocol for chronic wounds and changed every 48 hours. In the control group, saline gauze dressings were applied at the time of surgical debridement and changed twice a day thereafter. Measurements and photos were obtained to document wound progress. Main outcome measures included: 1) time to satisfactory healing (calculated from date of initial debridement to date of definitive closure, and 2) change in wound surface area (calculated from initial wound tracing to final tracing). Satisfactory healing in the V.A.C. group was achieved in 22.8 (+/- 17.4) days, compared to 42.8 (+/- 32.5) days in the control group. Surface area changes of 28.4% (+/- 24.3) average decrease in wound size in the V.A.C. group, compared to a 9.5% (+/- 16.9) average increase in the control group during measurement period.
Article
Data from 37 patients who underwent a transmetatarsal amputation from January 1993 to April 1996 were reviewed. The mean age and diabetes duration of the subjects were 54.9 (+/- 13.2) years and 16.6 (+/- 8.9) years, respectively. The follow-up period averaged 42.1 (+/- 11.2) months. At the time of follow-up, 29 (78.4%) of the 37 patients still had foot salvage, 8 (21.6%) had progressed to below-the-knee amputation, and 15 (40.5%) had undergone lower-extremity revascularization. Twelve (80%) of the 15 revascularized patients preserved their transmetatarsal amputation level at a follow-up of 36.4 months. The authors concluded that at a maximum of 3 years follow-up after initial amputation, transmetatarsal amputation was a successful amputation level.
Article
Promogran, a wound dressing consisting of collagen and oxidized regenerated cellulose, is more effective that standard care in treating chronic diabetic plantar ulcers. Randomized, prospective, controlled multicenter trial. University teaching hospitals and primary care centers. A total of 276 patients from 11 centers were enrolled in the study. The mean age of the patients was 58.3 years (range, 23-85 years). All patients had at least 1 diabetic foot ulcer. Patients were randomized to receive Promogran (n = 138) or moistened gauze (control group; n = 138) and a secondary dressing. Dressings were changed when clinically required. The maximum follow-up for each patient was 12 weeks. Complete healing of the study ulcer (wound). After 12 weeks of treatment, 51 (37.0%) Promogran-treated patients had complete wound closure compared with 39 (28.3%) control patientss, but this difference was not statistically significant (P =.12). The difference in healing between treatment groups achieved borderline significance in the subgroup of patients with wounds of less than 6 months' duration. In patients with ulcers of less than 6 months' duration, 43 (45%) of 95 Promogran-treated patients healed compared with 29 (33%) of 89 controls (P =.056). In the group with wounds of at least 6 months' duration, similar numbers of patients healed in the control (10/49 [20%]) and the Promogran (8/43 [19%]; P =.83) groups. No differences were seen in the safety measurements between groups. Patients and investigators expressed a strong preference for Promogran compared with moistened gauze. Promogran was comparable to moistened gauze in promoting wound healing in diabetic foot ulcers. It showed an additional efficacy for ulcers of less than 6 months' duration that was of marginal statistical significance. Furthermore, Promogran had a safety profile that was similar to that of moistened gauze, with greater user satisfaction. Therefore, Promogran may be a useful adjunct in the management of diabetic foot ulceration, especially in ulcers of less than 6 months' duration.
Article
Topical negative pressure is a novel non-pharmacological therapy that is now being adopted as a standard of care in wound care management programmes. This review assesses where and how it can be best used.
Article
The purpose of this manuscript was to describe a classification of diabetic foot surgery performed in the absence of critical limb ischaemia. The basis of this classification is centered on three fundamental variables which are present in the assessment of risk and indication: 1) the presence or absence of neuropathy (loss of protective sensation); 2) the presence or absence of an open wound; 3) the presence or absence of acute, limb-threatening infection. The conceptual framework for this classification is to define distinct classes of surgery in an order of theoretically increasing risk for high-level amputation. These classes include: Class I: Elective Diabetic Foot Surgery (procedures performed to treat a painful deformity in a patient without loss of protective sensation); Class II: Prophylactic (Procedure performed to reduce risk of ulceration or reulceration in person with loss of protective sensation but without open wound); Class III: Curative (Procedure performed to assist in healing open wound) and Class IV: Emergent (Procedure performed to limit progression of acute infection). The presence of critical ischaemia in any of these classes of surgery should prompt a vascular evaluation to consider a) the urgency of the procedure being considered and b) possible revascularization prior or temporally concomitant with the procedure. It is our hope that this system begins a dialogue amongst physicians and surgeons which can ultimately facilitate communication, enhance perspective, and improve care.