Effect of surgical incision management on wound infections in a poststernotomy patient population

ArticleinInternational Wound Journal 11 Suppl 1(s1):6-9 · June 2014with 568 Reads 
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DOI: 10.1111/iwj.12294 · Source: PubMed
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Abstract
Skin breakdown and infiltration of skin flora are key causative elements in poststernotomy wound infections. We hypothesised that surgical incision management (SIM) using negative pressure wound therapy over closed surgical incisions for 6-7 days would reduce wound infections in a comprehensive poststernotomy patient population. 'All comers' undergoing median sternotomy at our institution were analysed prospectively from 1 September to 15 October 2013 (study group, n = 237) and retrospectively from January 2008 to December 2009 (historical control group, n = 3508). The study group had SIM (Prevena™ Therapy) placed immediately after skin suturing and applied at -125 mmHg for 6-7 days, whereas control group received conventional sterile wound tape dressings. Primary endpoint was wound infection within 30 days. Study group had a significantly lower infection rate than control group: 1·3% (3 patients) versus 3·4% (119 patients), respectively (P < 0·05; odds ratio 2·74). In the study group, when the foam dressing was removed after 6-7 days, the incision was primarily closed in 234 of 237 patients (98·7%). SIM over clean, closed incisions for the first 6-7 postoperative days significantly reduced the incidence of wound infection after median sternotomy. Based on these data SIM may be cost-effective in patients undergoing cardiac surgery.

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  • ... There has been a documented decrease in SSI with ciNPT as compared to traditional surgical dressings across multiple fields: cardiac surgery, obstetrics, plastic surgery, vascular surgery, and orthopedic surgery [7][8][9][10][11]. However, Cochrane systematic reviews have shown low to very low certainty for all outcomes studied related to ciNPT, citing a serious risk of bias and imprecision [12][13]. ...
  • ... This helps to hold the incision edges together, reduces lateral tension and edema, stimulates perfusion, enhances the development of granulation tissue, reduces bacterial colonization of wound tissues, and protects the surgical site from external infectious sources. Recently, there has been growing interest in using the technique on closed incisions to prevent potentially severe surgical site infections and other wound complications in high-risk individuals [5][6][7][8][9][10]. The current availability of single-use, closed incision management (CIM) systems such as Prevena™ Therapy ® (Kinetic Concepts Inc., Wiesbaden, Germany) offers surgeons a convenient and practical means of delivering NPWT to their high-risk patients. ...
    Article
    Single-use, closed incision management (CIM) systems offer a practical means of delivering negative pressure wound therapy to patients. This prospective study evaluates the Prevena™ Therapy system in a cohort of coronary patients at high risk of deep sternal wound infection (DSWI). Fifty-three consecutive patients undergoing bilateral internal thoracic artery (BITA) grafting were preoperatively elected for CIM with the Prevena™ Therapy system, which was applied immediately after surgery. The actual rate of DSWI in these patients was compared with the expected risk of DSWI according to two scoring systems specifically created to predict either DSWI after BITA grafting (Gatti score) or major infections after cardiac surgery (Fowler score). The actual rate of DSWI was lower than the expected risk of DSWI by the Gatti score (3.8 vs. 5.8%, p = 0.047) but higher than by the Fowler score (2.3%, p = 0.069). However, while the Gatti score showed very good calibration (χ2 = 4.8, p = 0.69) and discriminatory power (area under the receiver-operating characteristic curve 0.838), the Fowler score showed discrete calibration (χ2 = 10.5, p = 0.23) and low discriminatory power (area under the receiver-operating characteristic curve 0.608). Single-use CIM systems appear to be useful to reduce the risk of DSWI after BITA grafting. More studies have to be performed to make stronger this finding.
  • ... 6 A growing body of evidence has reported positive benefits of NPWT over closed, clean incisions, particularly in high-risk patients with comorbidities, who are more likely to develop surgical site complications. [7][8][9][10][11][12] One unsolved surgical problem is the postoperative shifting of large mobilised tissue flaps, such as in abdominoplasties, especially when previous incisions have been performed in the abdominal area. 13 Seroma or haematoma formation as well as longstanding pseudobursa formations have been frequently addressed as sequelae following body-contouring surgery. ...
    Article
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    With an ageing population and a growing number of people with obesity and/or undergoing advanced cancer therapies, there is an increasing risk of surgical site complications including surgical site infections (SSIs). Postoperative shifting of large mobilised tissue flaps, such as in abdominoplasties, remains a dreaded complication, particularly following massive weight loss. Besides negative implications for the patient, surgical site complications result in an economic burden due to prolonged and repeated wound treatments. Preventative tools to reduce SSIs are needed. In selected patients at high risk of SSI and/or wound breakdown, use of incisional NPWT has been shown to actively manage clean, closed surgical incisions. This article contains a review of scientific and clinical research relevant to incisional NPWT use over surgical incisions, with particular emphasis on the common problem of wound breakdown and SSI following body-contouring surgery in post-bariatric patients. Although there are a growing number of studies describing use of incisional NPWT in a variety of applications, including vascular, cardiac and orthopaedic, a literature search revealed few studies regarding incisional NPWT use post body-contouring surgery. In a clinical study of seroma formation, less seroma and haematoma formation was reported in post-bariatric patients who received incisional NPWT, versus the control, following body-contouring surgery. In another study of widely applied external NPWT wound dressings over the ventral and lateral trunk following post-bariatric abdominal dermolipectomy, results showed a significant reduction in exudate formation, earlier drain removal, and decreased length of hospitalisation, compared with conventional treatment. Additional controlled studies are needed to validate the clinical impact of incisional NPWT following body-contouring surgery, and to determine proper recommendations for its use.
  • ... Grauhan et al [111] showed significant reduction of SSIs in obese patients (body mass index > 30 kg/m 2 ) with median sternotomy compared with patients treated with standard wound dressings. In general, retrospective studies and randomized controlled trials provided a substantial body of evidence that the use of this prophylactic wound dressing technique may reduce the incidence of wound infections [112][113][114] . ...
    Article
    Full-text available
    Despite many advances in prevention and perioperative care, deep sternal wound infection (DSWI) remains a pressing concern in cardiac surgery, with a still relevant incidence and with a considerable impact on in-hospital mortality and also on mid- and long-term survival. The permanent high impact of this complication is partially related to the increasing proportion of patients at high-risk for infection, as well as to the many patient and surgical risk factors involved in the pathogenesis of DSWI. The prophylactic antibiotic therapy is one of the most important tools in the prevention of DSWI. However, the choice of antibiotic, the dose, the duration, the adequate levels in serum and tissue, and the timing of antimicrobial prophylaxis are still controversial. The treatment of DSWI ranges from surgical revision with primary closure to surgical revision with open dressings or closed irrigation, from reconstruction with soft tissue flaps to negative pressure wound therapy (NPWT). However, to date, there have been no accepted recommendations regarding the best management of DSWI. Emerging evidence in the literature has validated the efficacy and safety of NPWT either as a single-line therapy, or as a "bridge" prior to final surgical closure. In conclusion, the careful control of patient and surgical risk factors - when possible, the proper antimicrobial prophylaxis, and the choice of validated techniques of treatment could contribute to keep DSWIs at a minimal rate.
  • ... A variety of sternal incision management strategies have been reported in the literature, including antimicrobial-impregnated gauze [12], triclosan-coated sutures [13], cyanoacrylatesealed Donati sutures [14], muscle flaps [15][16], and thorax support vests [17][18]. Several recent studies have reported positive outcomes using the Prevena™ Incision Management System (KCI, San Antonio, TX), a closed incision negative pressure therapy (ciNPT), over closed sternal incisions [18][19][20]. ...
    Article
    Full-text available
    Background: In patients with major comorbidities undergoing complex cardiothoracic surgery, incision management is critical. This retrospective review evaluated negative pressure over closed sternal incisions in cardiac patients with multiple comorbidities within 30 days post-median sternotomy. Methods: Records of post-sternotomy patients treated with Prevena™ Incision Management System (KCI, an Acelity company, San Antonio, TX), a closed incision negative pressure therapy (ciNPT), were reviewed from September 2010 through September 2014. Data collected included demographics, major comorbidities, types of surgery, relevant medical history, incision length, therapy duration, time to follow-up, and incision complications. Descriptive statistics were computed for continuous variables, frequency, and percentages for categorical variables. Results: Twenty-seven patients were treated with ciNPT between September 2010 and September 2014. The mean patient age was 62.5 (SD 7.9), and the mean body mass index (BMI) was 38.5 (SD 4.4) kg/m(2). Risk factors included obesity (BMI ≥ 30 kg/m(2), 27/27; 100%), diabetes (25/27; 92.6%), hypertension (16/27; 59.3%), and 20/27 patients (74%) had ≥ 5 comorbidities. Mean ciNPT duration was 5.6 (SD 0.9) days. Within 30 days post-surgery, 21/27 (77.8%) patients had intact incisions with good reapproximation. Two patients experienced minor dehiscences; four cases of superficial cellulitis were treated and resolved. One patient with a dehiscence was readmitted for intravenous antibiotics and five patients were managed successfully with antibiotics as outpatients. All patients had intact incisions with good skin approximation at final follow-up. Conclusions: In this retrospective study of post-sternotomy patients at high risk of developing complications, ciNPT over closed sternal incisions resulted in favorable outcomes within 30 days of surgery.
  • ... In a retrospective study with a historical cohort by Gibbs et al., (34) after controlling for body mass index (BMI) and diabetes, wound complication rates in the ciNPT group (n = 103) were found to be equivalent to those in the standard dressing group (n = 867). Three other retrospective studies with a historical control group observed lower rates of SSI, SSOs, wound morbidity and re-operation in the ciNPT group compared with the historical controls (16,51,63).Overall, a majority of these studies reported that ciNPT use was associated with decreases in wound complications, wound dehiscence, SSIs, haematoma/seroma formation and incisional drainage. ...
    Article
    Surgical site occurrences (SSOs) affect up to or over 25% of patients undergoing operative procedures, with the subset of surgical site infections (SSIs) being the most common. Commercially available closed incision negative pressure therapy (ciNPT) may offer surgeons an additional option to manage clean, closed surgical incisions. We conducted an extensive literature search for studies describing ciNPT use and assembled a diverse panel of experts to create consensus recommendations for when using ciNPT may be appropriate. A literature search of MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials using key words 'prevention', 'negative pressure wound therapy (NPWT)', 'active incisional management', 'incisional vacuum therapy', 'incisional NPWT', 'incisional wound VAC', 'closed incisional NPWT', 'wound infection', and 'SSIs' identified peer-reviewed studies published from 2000 to 2015. During a multidisciplinary consensus meeting, the 12 experts reviewed the literature, presented their own ciNPT experiences, identified risk factors for SSOs and developed comprehensive consensus recommendations. A total of 100 publications satisfied the search requirements for ciNPT use. A majority presented data supporting ciNPT use. Numerous publications reported SSI risk factors, with the most common including obesity (body mass index ≥30 kg/m(2) ); diabetes mellitus; tobacco use; or prolonged surgical time. We recommend that the surgeon assess the individual patient's risk factors and surgical risks. Surgeons should consider using ciNPT for patients at high risk for developing SSOs or who are undergoing a high-risk procedure or a procedure that would have highly morbid consequences if an SSI occurred.
  • ... Although patients with PTS receiving interventional or surgical treatment tend to be young and healthy, the rate of wound complications and lymph fistula after endophlebectomy is high [9]. Data that address complications after endophlebectomy are scarce [7]. ...
    Article
    Full-text available
    Background: New endovascular techniques facilitate treatment of complex deep vein obstructions in cases of post-thrombotic syndrome. In a relevant number of these patients, endophlebectomy including the implantation of an arteriovenous fistula between the common femoral artery and the femoral vein is indispensable in order to establish a good inflow. These procedures display a high risk of wound complications. Despite conservative efforts to prevent these postoperative complications, wound healing problems occur in more than 20 % of cases. The present case report is the first description of wound dressing using a PREVENA® incision management system in cases of endophlebectomy. Case presentation: A single center's experience with the incision management system PREVENA®, which was used after endophlebectomy and venous stenting in complex hybrid procedures in three white men aged 46 years, 53 years, and 61 years is the subject of this case report. Although the surgical procedures were performed under therapeutical anticoagulation and took a couple of hours, no wound complications occurred. Conclusions: These encouraging results underline a potential benefit of the incision management system PREVENA® in cases of complex venous recanalization including endophlebectomy of the femoral vein as well as the implantation of an arteriovenous fistula.
  • ... Application of ciNPT has generally been associated with safe administration and a low risk of side effects for patients with cardiothoracic, vascular, gynaecological, general, traumatic, plastic, oncological and orthopaedic incisions [11,[17][18][19][20][21][22][23][24]. There is consensus that intact skin should not be exposed to polyurethane foam because the foam can excoriate and blister the tissue [21]. ...
    Article
    Full-text available
    Aim: Surgical site infection (SSI) and wound dehiscence are dreaded complications following laparotomy in general surgical patients and can potentially occur more often in various comorbid states. Based on the positive effect of negative pressure wound therapy (NPWT) on open and complicated wounds, it has been used for at-risk surgical incisions with the aim of redistributing lateral tension and holding incision edges together. The aim of the present study was to compare the rate of wound complications following laparotomy in high-risk general surgical patients with a clean incision treated with closed incision negative pressure therapy (ciNPT) with conventional care. Method: A retrospective review was performed of the hospital medical records of patients who underwent laparotomy between October 1, 2010 and March 31, 2012. Records of 69 patients who received ciNPT and 112 who were managed by adherent gauze dressings were included in the final analysis. Results: Two (2.9%) patients in the ciNPT group and 23 (20.5%) in the non-NPWT group developed a wound complication following laparotomy (p <0.0009). The relative risk (RR) was 0.14 (0.03-0.58), suggesting that infection is less likely to occur in ciNPT-treated incisions, compared with gauze dressings. Conclusions: Closed incision NPT was associated with a positive clinical outcome and was a safe and effective method of post-surgical management in in patients considered to be at risk of developing wound complications following laparotomy. This article is protected by copyright. All rights reserved.
  • ... 8,12,21,22 Similar evidence is building for single-use NPWT devices based on open-cell foam. 11,23,24 In an earlier study, Wilkes et al 14 demonstrated, through FEA modeling and a benchtop tissue model, that a single-use NPWT system based on open-cell foam is able to apply a lateral force to a closed surgical incision. This study has now established that a canister-less NPWT system based on a silicone adhesive multilayer dressing also applies a lateral closing force to surgical incisions. ...
    Article
    Full-text available
    Objectives: The use of negative pressure wound therapy (NPWT) on closed surgical incisions is an emerging technology that may reduce the incidence of complications such as surgical site infections. One of the mechanisms through which incisional NPWT is thought to operate is the reduction of lateral tension across the wound. Methods: Finite element analysis computer modeling and biomechanical testing with Syndaver SynTissue™ synthetic skin were used to explore the biomechanical forces in the presence of the PICO(⋄) (Smith & Nephew Ltd, Hull, United Kingdom) negative pressure wound therapy system on a sutured incision. Results: Finite element analysis modeling showed that the force on an individual suture reduced to 43% of the force without negative pressure (from 1.31 to 0.56 N) at -40 mm Hg and to 31% (from 1.31 to 0.40 N) at -80 mm Hg. Biomechanical testing showed that at a pressure of -80 mm Hg, 55% more force is required for deformations in the tissue compared with the situation where no negative pressure wound therapy dressing is active. The force required for the same deformation at -120 mm Hg is only 10% greater than at -80 mm Hg, suggesting that most of the effect is achieved at -80 mm Hg. Conclusions: The results show that a canister-less single-use NPWT device is able to reduce the lateral tension across a closed incision, which may explain observed clinical reductions in surgical site complications with incisional NPWT.
  • ... We found 6 RCTs, [6,9,[21][22][23] 3 prospective observational studies, [19,20,24] 10 retrospective observational studies, [25][26][27][28][29][30][31][32][33][34] and 1 article [35] with both retro-and prospective data. In the observational studies, the use of pNPWT was based on the surgeons decision in 6 studies [ (before-after) in 8 studies. ...
    Article
    Full-text available
    Objective: Systematically review and Grading of Recommendations Assessment, Development, and Evaluation (GRADE) studies on prophylactic negative pressure wound therapy (pNPWT) to prevent surgical site infections (SSIs). Introduction: pNPWT has been suggested as a new method to prevent wound complications, specifically SSIs, by its application on closed incisional wounds. Methods: This review was conducted as part of the development of the Global Guidelines for prevention of SSIs commissioned by World Health Organization in Geneva. PubMed, Embase, CENTRAL, CINAHL, and the World Health Organization database between January 1, 1990 and October 7, 2015 were searched. Inclusion criteria were randomized controlled trials and observational studies comparing pNPWT with conventional wound dressings and reporting on the incidence of SSI. Meta-analyses were performed with a random effect model. GRADE Pro software was used to qualify the evidence. Results: Nineteen articles describing 21 studies (6 randomized controlled trials and 15 observational) were included in the review. Summary estimate showed a significant benefit of pNPWT over conventional wound dressings in reducing SSIs in both randomized controlled trials and observational studies, odds ratio of 0.56 (95% confidence interval, 0.32-0.96; P = 0.04) and odds ratio of 0.30 (95% confidence interval, 0.22-0.42; P < 0.00001), respectively. This translates into lowering the SSI rate from 140 to 83 (49-135) per 1000 patients and from 106 to 34 (25-47) per 1000 patients, respectively. In stratified analyses, these results were consistent in both clean and clean-contaminated procedures and in different types of surgery, however results were no longer significant for orthopaedic/trauma surgery. The level of evidence as qualified with GRADE was however low. Conclusions: Low-quality evidence indicates that prophylactic NPWT significantly reduces the risk of SSIs.
  • ... We identified 19 publications describing 20 studies (six RCTs [126][127][128][129][130] and 14 observational studies [131][132][133][134][135][136][137][138][139][140][141][142][143][144] ). Overall, meta-analyses of RCTs and observational studies showed that pNPWT has a significant benefit in reducing the risk of SSI in patients with a primarily closed surgical incision compared with conventional postoperative wound dressings (RCTs: OR 0·56; 95% CI 0·32-0·96; observational studies: OR 0·30; 0·22-0·42). ...
    Article
    Full-text available
    Surgical site infections (SSIs) are the most common health-care-associated infections in developing countries, but they also represent a substantial epidemiological burden in high-income countries. The prevention of these infections is complex and requires the integration of a range of preventive measures before, during, and after surgery. No international guidelines are available and inconsistencies in the interpretation of evidence and recommendations in national guidelines have been identified. Considering the prevention of SSIs as a priority for patient safety, WHO has developed evidence-based and expert consensus-based recommendations on the basis of an extensive list of preventive measures. We present in this Review 16 recommendations specific to the intraoperative and postoperative periods. The WHO recommendations were developed with a global perspective and they take into account the balance between benefits and harms, the evidence quality level, cost and resource use implications, and patient values and preferences.
  • ... [5,6] To decrease the risk of SSIs in the condition of contamination, numerous wound closure methods as the optimal therapeutic modality have been developed, like delayed primary closure, subcutaneous drain placement with or without irrigation, and loose dermal approximation with staples and wicks. [7,8] Although there was clear evidence supporting prophylactic antibiotics, the effectiveness of other preventive techniques was not confirmed, such as preoperative skin antisepsis, intraoperative glove change, suction wound drainage, and different wound closure techniques. [9,10] Since its introduction into clinical care over a decade ago, vacuum sealing drainage (VSD) has become a prevalent treatment modality used in the management of various types of tissue injuries including acute wounds, chronic wounds, and skin grafts. ...
    Article
    Full-text available
    Surgical site infection (SSI) continues to be an issue in abdominal surgery, especially for contaminated (class III) and dirty-infected (class IV) wounds. Vacuum sealing drainage (VSD) was reported effective in the management of various types of wounds or skin grafts. Our goal was to investigate the efficacy of prophylactic VSD to better orient their medicosurgical care of high-risk incisions following laparotomy in a pediatric population. A total of 331 pediatric patients with contaminated (class III) and dirty-infected (class IV) wounds following emergency laparotomy were retrospectively reviewed between January 2005 and January 2013. Among them, 111 cases were placed with prophylactic VSD when incisions were closed. Clinical outcomes, including, overall surgical site complication, device effectiveness, and mean postoperative LOS were evaluated based on VSD usage or not. VSD was applied for an average of 5.8 days (range, 5–7 days), with 3 to 15 mL sucked fluid. The overall SSIs rate was 3% for patients with prophylactic VSD and 17% for patients with convention dressing (OR, 0.27; 95% CI, 0.10–0.71, P = 0.004). In patients with prophylactic VSD, only 1 of 96 wound developed postoperative incision dehiscence, which is significant reduced compared with patients for conventional dressings (OR, 0.12; 95% CI, 0.01–0.95; P = 0.017) (Table 2). It also exhibited a decreased mean postoperative LOS (P < 0.001) for prophylactic VSD over conventional dressings. Our study demonstrated beneficial postoperative clinical effects of prophylactic VSD for high-risk laparotomy incisions following emergency laparotomy, such as shorter length of hospitalization, which may be attributed to the reduced overall SSIs rate.
  • ... [12][13][14][15] Furthermore, NPWT has been used over clean, closed surgical incisions with positive clinical outcomes. 5,[16][17][18][19][20] It is thought that closed incision negative pressure therapy (ciNPT) can help manage surgical incisions through the reduction of incision line tension, removal of fluids and protection of the incision from the external environment. [21][22][23][24][25] Here, we report our experience using ciNPT in a small group of sternotomy or mediastinal surgery patients. ...
    Article
    Full-text available
    Objective: Postoperative delayed wound healing, surgical site infections (SSIs), and other wound complications are associated with increased morbidity and health-care costs. In cardiothoracic surgery, wound complications can have life-threatening consequences. In recent years, negative pressure wound therapy (NPWT) has been applied over closed surgical incisions to help reduce tension and protect from external contamination. We report our initial experiences using a closed incision negative pressure therapy (ciNPT) over clean, closed sternotomy incisions at an Irish tertiary referral centre. Method: A retrospective record review identified 10 patients (4 females, 6 males) where ciNPT was used following sternotomy for cardiac surgery or other mediastinal surgery between January 2012 and March 2013. Results: The patients had an average age of 71.5±14.18 years (range: 44-89 years). Patient comorbidities included obesity, hypertension, active tobacco use, chronic obstructive pulmonary disease, and diabetes mellitus. Patients underwent coronary artery bypass grafting (CABG), aortic valve replacement (AVR), AVR and CABG, or removal of a thymic mass or mediastinal cyst. ciNPT was left in place for an average of 6±0.82 days. All incisions healed without complications. Conclusion: ciNPT use should be considered for patients at risk for postoperative SSI development or other wound complications.
  • ... 4,5 Recently, application of negative pressure therapy over clean, closed surgical incisions (closed incision negative pressure therapy, ciNPT) has been reported in various settings to be associated with a reduced rate of SSIs. [6][7][8][9][10][11][12] However, these recent studies have been published in multiple surgical procedures and multiple ciNPT devices, which makes it difficult for healthcare providers to determine if ciNPT is beneficial to their practice specialty. This systematic review and metaanalysis assessed the impact of ciNPT on SSI occurrence after vascular surgery via groin incision. ...
    Article
    Full-text available
    Surgical site infection after groin incision is a common complication and a financial burden to patients and healthcare systems. Closed incision negative pressure therapy (ciNPT) has been associated with decreased surgical site infection rates in published literature. This meta-analysis examines the effect of ciNPT (PREVENA™ Incision Management System; KCI, San Antonio, TX) versus traditional postsurgical dressing use in reducing surgical site infection rates over closed groin incisions following vascular surgery.
  • ... Under the designation closed incision negative pressure therapy (ciNPT), this new technique has resulted in many significant clinical results (11,13,25,26). Since 2010, multiple studies and case reports comparing standard-of-care dressings to ciNPT have reported a decrease in SSIs in a wide spectrum of traumatic, orthopaedic, abdominal, sternal and plastic surgery incisions (27)(28)(29)(30)(31)(32)(33)(34)(35)(36)(37). The reason for this success may be due to the reported mechanisms of action of the ciNPT, which protects the incision from external wound contamination, strengthens the cohesiveness of the wound edges, removes fluids and infectious materials from the wound, decreases the lateral tension around the incision and facilitates oxygen saturation and blood microcirculation within the incision area (11,38,39). ...
    Article
    Full-text available
    Groin wound infections in patients undergoing vascular procedures often cause a lengthy process of wound healing. Several clinical studies and case reports show a reduction of surgical site infections (SSIs) in various wound types after using closed incision negative pressure therapy (ciNPT). The aim of this prospective, randomised, single-institution study was to investigate the effectiveness of ciNPT (PREVENA™ Therapy) compared to conventional therapy on groin incisions after vascular surgery. From 1 February to 30 October 2015, 100 patients with 129 groin incisions were analysed. Patients were randomised and treated with either ciNPT (n = 58 groins) or the control dressing (n = 71 groins). ciNPT was applied intraoperatively and removed on days 5–7 postoperatively. The control group received a conventional adhesive plaster. Wound evaluation based on the Szilagyi classification took place postoperatively on days 5–7 and 30. Compared to the control group, the ciNPT group showed a significant reduction in wound complications (P < 0·0005) after both wound evaluation periods and in revision surgeries (P = 0·022) until 30 days postoperatively. Subgroup analysis revealed that ciNPT had a significant effect on almost all examined risk factors for wound healing. ciNPT significantly reduced the incidence of incision complications and revision procedures after vascular surgery.
  • ... Por otro lado, aparte de la reducción de la IHQ, la normotermia se asocia a una disminución de los eventos cardiológicos, del sangrado y de las necesidades transfusionales. 13. Se sugiere el uso de protocolos de control intensivo de la glucemia en pacientes diabéticos y no diabéticos (recomendación condicional, evidencia baja). ...
    Article
    Full-text available
    Resumen Las infecciones nosocomiales constituyen el efecto adverso sobre la seguridad del paciente más frecuente a nivel mundial. De todas las infecciones nosocomiales, la infección de herida quirúrgica (IHQ) es la más habitual en países en vías de desarrollo, y la segunda en frecuencia en los países desarrollados. En noviembre de 2016, la Organización Mundial de la Salud (OMS) publicó un documento con una serie de recomendaciones, basadas en la evidencia, para la prevención de la IHQ: «Global guidelines for the prevention of surgical site infection». De forma paralela, un grupo de expertos españoles de diferentes sociedades científicas, conscientes de la importancia de este problema, han elaborado un documento en materia de antisepsia de la piel, el cual recoge en buena medida parte de las recomendaciones sugeridas por el manuscrito de la OMS, adaptadas a la realidad de nuestro entorno. En el presente documento, se exponen las recomendaciones extraídas de ambos documentos, aplicables al ámbito de la cirugía cardiovascular de nuestro país.
  • ... Evidence for the benefits of NPWT in preventing wound complications after cardiothoracic surgery has accumulated through published retrospective chart review studies [46,57] and case studies [28,47]. Grauhan [46]. ...
    Article
    Full-text available
    Abstract Negative pressure wound therapy is a concept introduced initially to assist in the treatment of chronic open wounds. Recently, there has been growing interest in using the technique on closed incisions after surgery to prevent potentially severe surgical site infections and other wound complications in high-risk patients. Negative pressure wound therapy uses a negative pressure unit and specific dressings that help to hold the incision edges together, redistribute lateral tension, reduce edema, stimulate perfusion, and protect the surgical site from external infectious sources. Randomized, controlled studies of negative pressure wound therapy for closed incisions in orthopedic settings (which also is a clean surgical procedure in absence of an open fracture) have shown the technology can reduce the risk of wound infection, wound dehiscence, and seroma, and there is accumulating evidence that it also improves wound outcomes after cardiothoracic surgery. Identifying at-risk individuals for whom prophylactic use of negative pressure wound therapy would be most cost-effective remains a challenge; however, several risk-stratification systems have been proposed and should be evaluated more fully. The recent availability of a single-use, closed incision management system offers surgeons a convenient and practical means of delivering negative pressure wound therapy to their high-risk patients, with excellent wound outcomes reported to date. Although larger, randomized, controlled studies will help to clarify the precise role and benefits of such a system in cardiothoracic surgery, limited initial evidence from clinical studies and from the authors' own experiences appears promising. In light of the growing interest in this technology among cardiothoracic surgeons, a consensus meeting, which was attended by a group of international experts, was held to review existing evidence for negative pressure wound therapy in the prevention of wound complications after surgery and to provide recommendations on the optimal use of negative pressure wound therapy on closed median sternal incisions after cardiothoracic surgery.
  • ... 28 Another study in patients undergoing bilateral internal thoracic artery grafting utilized ciNPT in 53 high-risk patients, defined by Gatti and Fowler risk scores. 29 The cohort had lower rate of deep sternal wound infections when compared with those expected from Gatti scores although there was no significant difference with Fowler score predictions. The authors concluded that although the risk predisposition was difficult to assess, all patients be considered for ciNPT. ...
    Article
    Full-text available
    Vascular groin wound and median sternotomy infections are challenging complications that may lead to serious sequela. Traditional gauze dressings have poor bacteria barrier properties, and so there has been a recent enthusiasm for the use of closed-incision negative-pressure therapy as an effective closed environment, which controls exudate and helps hold the incision edges together. Studies suggest that it may reduce surgical site infection in cardiothoracic and vascular surgery.
  • ... While only two studies were identified in the literature search, they provided differing conclusions [14,28]. Additionally, since 2009, only three other studies examining the health economics of ciNPT use have been published [33][34][35]. Chopra et al. [33] report that in their 829 patients undergoing abdominal wall reconstruction, ciNPT use resulted in an estimated cost savings of $1,542.52 and could be a cost-effective option when the estimated SSI rate is above 16% for the patient population. Similarly, Grauhan et al. [34] reported an estimated cost savings of 60,000,000€ to 90,000,000€ per year in Germany for patients undergoing cardiac surgery. ...
    Article
    Full-text available
    Surgical site infection and other common surgical site complications (dehiscence, hematoma, and seroma formation) can lead to serious and often life-threatening complications. Gauze, adhesive dressings, and skin adhesives have traditionally been utilized for incision management. However, the application of negative pressure wound therapy over clean, closed surgical incisions (closed incision negative pressure therapy, ciNPT), has become a recent option for incision management. A brief review of ciNPT clinical evidence and health economic evidence are presented. A brief literature review was performed using available publication databases (PubMed, Ovid®, Embase®, and QUOSA™) for articles in English reporting on the use of ciNPT between October 1, 2016, to March 31, 2019. The successful application of ciNPT over clean, closed wounds has been reported in a broad spectrum of patients and operative interventions, resulting in favorable clinical results. Four of the five studies that examined health economics following the use of ciNPT reported a potential reduction in the cost of care. The authors' own experience and published results suggest that patients at high risk for developing a surgical site complication may benefit from the use of ciNPT during the immediate postoperative period. Additional studies are needed across various surgical disciplines to further assess the safety, and cost-effectiveness of ciNPT use in patient populations.
  • ... In summary, the RCTs indicate that iNPWT reduces SSI rates from 15% to 9% [65][66][67]85,86,[95][96][97][98][100][101][102][103][104][105][106][107]. We also identified 37 observational studies that indicated iNPWT is effective in reducing SSI (OR 0.35; 95% CI 0.20, 0.62; p = 0.0003) [19,39,[51][52][53][54][55][56][57][58][59][60][61][62]84,[91][92][93][94][108][109][110][111][112][113][114][115][116][117][118][119][120][121][122][123]. An overview of the updated meta-analyses is presented in Table 1. ...
    Article
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    Background: With the prospect of antibiotic failure in the post-antibiotic era, strategies that prevent surgical site infection (SSI) are increasingly important. Current literature suggests that incisional Negative Pressure Wound Therapy (iNWPT) is a promising intervention. Methods: Based on published literature regarding iNPWT, its mechanisms of action, and clinical results, a narrative summary was built, including both the experimental as well as the clinical literature. Results: The experimental literature indicates that iNPWT provides a barrier against external contamination before re-epithelialization, increases blood flow and lymphatic clearance, and reduces edema. Meta-analyses of randomized studies indicate that iNWPT is effective in reducing SSI. We did not identify studies that assessed bacterial clearance during iNPWT in contaminated surgical sites, nor did we identify clinical studies that specified they omitted concomitant antibiotic prophylaxis. Conclusions: Moderate quality evidence indicates that iNWPT reduces SSI, although data without the concomitant use of antibiotic prophylaxis are lacking. The iNPWT is likely effective as a result of its barrier function and optimization of the surgical site micro-environment. For now, iNPWT is recommended for incorporation in SSI prevention bundles. The iNPWT as a substitute for antibiotic prophylaxis is not recommended currently. Further reduction of SSI by iNPWT will lessen the need for therapeutic use of antibiotic agents.
  • ... Observational and randomized studies have demonstrated reduced rates of SWI with use of NPIMS. 17,18 In an effort to reduce SWI in high-risk patients, an NPIMS was introduced at our institution in 2014. This affords an ideal opportunity to evaluate the cost and efficacy of this intervention. ...
  • ... In the subsequent period successful NPWT was applied on primarily closed wounds with the aim of preventing the wide spectrum of WHC. This new procedure, under the term closed incision negative pressure therapy (ciNPT), has led in abdominal, sternal, traumatic, orthopedic, and plastic surgery incisions to reduction of SSIs since 2010 [23][24][25][26][27][28]. ...
  • ... Não houve conflito de interesses na condução desta re visão e também não ocorreu nenhum tipo de financiamento para o estudo. Os sete artigos selecionados foram identificados em A1 (17) ; A2 (18) ; A3 (19) ; A4 (20) ; A5 (21) ; A6 (22) ; A7 (23) . Alguns dados referentes aos artigos incluídos nesta pesquisa, como identificação do estudo, autores, local e data da publicação e delineamento do estudo são apresentados no Quadro 2. Os estudos foram publicados de 2007 a 2014. ...
    Article
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    Objective: To identify and describe which dressings are recommended to prevent surgical site infection in hospitalized adult patients after cardiac surgeries. Method: Integrative review carried out in the databases MEDLINE, LILACS, CINAHL, Web of Science, Cochrane and Scopus. Studies related to dressing in the postoperative period of cardiac surgery were selected. Results: Seven articles were included, with the following dressings: negative pressure wound therapy, silver nylon dressing, transdermal delivery of continuous oxygen and impermeable adhesive drape. The dressings that led to reduction of infection were negative pressure and silver nylon dressings. Conclusion: It was not possible to identify which dressing is most recommended, however, some studies show that certain types of dressings were related to the reduction of infection. Clinical trials with a rigorous methodological design and representative samples able to minimize the risk of bias should be conducted to evaluate the effectiveness of dressings in the prevention of surgical site infection.
  • ... Wound dehiscence and complications are lowered with the use of iNPWT and its aforementioned benefits. Recent literature estimates a reduction of ~50% reduction in wound dehiscence rates, across various surgical specialties [23,[45][46][47][48][49][50]. ...
    Chapter
    Negative pressure wound therapy (NPWT) is widely used for chronic and acute open wounds, with clinically proven benefits of faster wound healing by promoting granulation tissue growth and increased perfusion and facilitating epithelialization and contraction. Improved outcomes on open wounds prompted the application of NPWT on closed surgical incisions. The application of NPWT, in the immediate postoperative period, reduces surgical site infections (SSIs) and wound dehiscence by 50% in high-risk patients. The negative pressure reduces wound edema and improves local perfusion and lymphatic f low, thereby minimizing hematoma and seroma rates. The improved perfusion and oxygenation facilitate quicker wound healing as well as minimize ischemic complications like f lap necrosis. Recent literature supports enhanced wound healing and superior scar appearance as well as improved wound maturity, evidenced by 50% more force required to pull apart a sutured incision. Improved outcomes of incisional NPWT are reported from various surgical procedures on abdominal, breast, orthopedic, vascular, cardiac, and plastic surgeries. Further clinical studies and cost-benefit analysis are needed to recommend routine postoperative use of incisional NPWT in high-risk and low-risk patient population.
  • ... In total, we identified 39 retrospective observational studies, 41,46 -82 12 prospective observational studies, [83][84][85][86][87][88][89][90][91][92][93][94] and 31 RCTs. 8,12, Most studies used a commercially available device for iNPWT delivery, set between À50 to À150 mm Hg of subatmospheric pressure. ...
    Article
    Full-text available
    Objective: The aim of this study was to evaluate the efficacy of iNPWT for the prevention of postoperative wound complications such as SSI. Summary of background data: The 2016 WHO recommendation on the use of iNPWT for the prevention of SSI is based on low-level evidence, and many trials have been published since. Preclinical evidence suggests that iNPWT may also prevent wound dehiscence, skin necrosis, seroma, and hematoma. Methods: PubMed, EMBASE, CINAHL, and CENTRAL were searched for randomized and nonrandomized studies that compared iNPWT with control dressings. The evidence was assessed using the Cochrane Risk of Bias Tool, the Newcastle-Ottawa scale, and GRADE. Meta-analyses were performed using random-effects models. Results: High level evidence indicated that iNPWT reduced SSI [28 RCTs, n = 4398, relative risk (RR) 0.61, 95% confidence interval [CI]: 0.49-0.76, P < 0.0001, I = 27%] with a number needed to treat of 19. Low level evidence indicated that iNPWT reduced wound dehiscence (16 RCTs, n = 3058, RR 0.78, 95% CI: 0.64-0.94). Very low-level evidence indicated that iNPWT also reduced skin necrosis (RR 0.49, 95% CI: 0.33-0.74), seroma (RR 0.43, 95% CI: 0.32-0.59), and length of stay (pooled mean difference -2.01, 95% CI: -2.99 to 1.14). Conclusions: High-level evidence indicates that incisional iNPWT reduces the risk of SSI with limited heterogeneity. Low to very low-level evidence indicates that iNPWT also reduces the risk of wound dehiscence, skin necrosis, and seroma.
  • Article
    Topical negative pressure wound therapy (NPWT) is being used with increasing frequency to treat closed surgical incisions that are at high risk for wound complications. Known benefits of topical NPWT include improved perfusion, physical wound support and isolation. This case series report of four colon operations introduces a method to manage closed surgical incisions that is designed to potentiate the effects of topical NPWT. Channel drains are placed vertically through a closed incision and in contact with the foam sponge of a NPWT dressing. The drains transmit negative pressure into the wound in order to enhance fluid removal, reduce dead space and improve tissue apposition for primary healing. Dr Leiboff received no funding for this study. Dr Leiboff is President of Tools for Surgery, L.L.C.
  • Article
    Surgical site infection (SSI) is a common healthcare-associated infection and complicates up to 10-20% of operations with considerable strain on healthcare resources. Apart from the widely adopted use of appropriate hair removal, antibiotic prophylaxis, avoidance of hypothermia and perioperative glycaemic control to reduce SSIs, this review has considered new research and systematic reviews, and whether their findings should be included in guidelines. The efficacy of preoperative bathing/showering, antibiotic prophylaxis for clean surgery and perioperative oxygen supplementation to reduce the risk of SSI is still in doubt. By contrast, the use of 2% chlorhexidine in alcohol skin preparation, postoperative negative pressure wound therapy and antiseptic surgical dressings do show promise. Antimicrobial sutures in independent meta-analyses were found to reduce the risk of SSI after all classes of surgery (except dirty) whereas the use of wound guards, or diathermy skin incision (compared with scalpel incision), did not. The incidence of SSI after surgery is not falling. Based on this review of published trials and evidence-based systematic reviews some advances might be included into these care bundles. More research is needed together with improved compliance with care bundles.
  • Article
    Full-text available
    Introduction: Despite the progress of prevention and peri-operative care of cardiac surgery patients, complications of the surgical wound still occur to 1-3% of patients and they are connected with high rates of hospital mortality.Aim: The present systematic review aims to investigate the effectiveness of the application of negative pressure wound therapy in median sternotomy wounds after cardiac surgery that occur deep infections.Material and Method: All the relevant Greek and International bibliography was searched to Pubmed, Cinahl, Sciverse Scopus and Proquest database. The Key words that were used were negative pressure wound treatment AND sternotomy AND cardiac surgery regarding the pursuit of the title, the abstract or the key words for publications from 2012 and after.Results: From 123 articles, 7 articles were finally chosen for studying of the full text. According to the results of the review, negative pressure wound treatment’s use to median sternotomy wounds provide the healing, the treatment and the prevention of infections and contributes to the reduction of the time and cost of hospitalization.Conclusions: The need to carry out more randomized clinical trials is highlighted so that the results can be generalized.
  • Article
    Sternal wound infections are considered a costly and potentially devastating consequence of the median sternotomy in cardiothoracic surgery. Surgical incision management employs the technique of applying a closed, negative pressure vacuum dressing to a closed wound. Several studies have demonstrated a reduction in sternal wound infections using this system. A retrospective audit of cases receiving surgical incision management demonstrated a statistically significant reduction in sternal wound infections against a predicted rate. Of the 62 patients identified, only one was complicated by a sternal wound infection with the greatest reduction seen in the high-risk infection group. Although smaller in size, the results compared well to trials conducted in larger European and US centres. Although not advocating surgical incision management for routine use, it should be considered on patients considered high-risk for sternal wound infection, such as diabetics, the elderly and the obese. Copyright © 2015. Published by Elsevier B.V.
  • Article
    Negative-pressure therapy has recently been used over closed incisions to decrease surgical-site occurrences, including infection and dehiscence. A meta-analysis was performed to evaluate the effectiveness of closed incision negative-pressure therapy in lowering the incidence of surgical-site infections compared with standard dressings. A literature search was conducted to find publications comparing closed incision negative-pressure therapy to standard incisional care. A fixed-effects model was used to assess between-study and between-incision location subgroup heterogeneity and effect size. Funnel plots were used to assess publication bias. The overall weighted average rates of surgical-site infection in the closed incision negative-pressure therapy and control groups were 6.61 percent and 9.36 percent, respectively. This reflects a relative reduction in surgical site infection rate of 29.4 percent. A decreased likelihood of surgical-site infection was evident in the closed incision negative-pressure therapy group compared with the control group across all studies, and across all four incision location subgroups. Across all studies, odds of surgical-site infections decreased 0.564 (p < 0.00001). After excluding groin incision studies because of heterogeneity following sensitivity analysis, the odds of surgical-site infection decrease was still 0.496 (p < 0.00001). In addition, overall rates of dehiscence in closed incision negative-pressure therapy and control groups were 5.32 percent and 10.68 percent, respectively. The results of this meta-analysis suggest that closed incision negative-pressure therapy is a potentially effective method for reducing surgical-site infections. It also appears that closed incision negative-pressure therapy may be associated with a decreased incidence of dehiscence, but the published data available were too heterogeneous to perform meta-analysis.
  • Article
    Background: Sternal wound infections (SWIs) can be a devastating long-term complication with significant morbidity and health care cost. The purpose of this analysis was to evaluate the cost-effectiveness of negative pressure incision management systems (NPIMS) in cardiac surgery. Materials and methods: All cardiac surgery cases at an academic hospital with risk scores available (2009-2017) were extracted from an institutional database (n = 4455). Patients were stratified by utilization of NPIMS, and high risk was defined as above the median. Costs included infection-related readmissions and were adjusted for inflation. Multivariable regression models assessed the risk-adjusted cost of SWI and efficacy of NPIMS use. Cost-effectiveness was modeled using TreeAge Pro using institutional results. Results: The rate of deep SWI was 0.9% with an estimated cost of $111,175 (P < 0.0001). The rate of superficial SWI was 0.8% at a cost of $7981 (P = 0.08). Risk-adjusted NPIMS use was not significantly associated with reduced SWI (OR 1.2, P = 0.62) and thus not cost-effective. However, in the high-risk cohort with an OR 0.84 (P = 0.72) and SWI rate of 2.3%, NPIMS use cost $205 per patient with an incremental cost-effectiveness ratio of $179,092. Therefore, NPIMS is estimated to be cost-effective with a deep SWI rate over 1.3% or improved efficacy (OR < 0.83). Conclusions: SWIs are extremely expensive complications with estimates of $111,175 for deep yet only $7981 for superficial. Although NPIMS was not cost-effective for SWI prevention as currently utilized, a protocol for use on patients with a higher risk of sternal infection could be cost-effective.
  • Article
    Groin wound infections pose a major problem in vascular surgery. Closed‐incision negative pressure therapy (ciNPT) was especially designed for the management of incisions at risk of surgical site infections. The aim of this study was to investigate whether ciNPT is able to reduce the incidence of wound infections after vascular surgery. Data on 132 consecutive patients, scheduled for vascular surgery with a longitudinal femoral cutdown, were collected prospectively. All patients were randomised either to the ciNPT group (n = 64) or the control group (n = 68) with conventional dressing. In the ciNPT group, the foam dressing was applied intraoperatively and removed after 5 days. The control group received an absorbent dressing. All wounds were evaluated after 5 and 42 days. Infections were graded according the Szilagyi classification (I–III°). There were no significant differences between both groups considering patient characteristics. Indications for surgery were peripheral arterial disease in 95% (125/132) and aneurysm in 5% (7/132). The overall infection rates were 14% (9/64) in the ciNPT group and 28% (19/68) in the control group (P = 0·055). Early infections were observed in 6% (4/64) of the ciNPT group and 15% (10/68) of the control group (P = 0·125). ciNPT did not reduce infection rates associated with different risk factors for infection. While the experiences with the ciNPT device were encouraging, the study fails to provide evidence of the efficacy of the device to reduce groin wound infections after vascular surgery. It illustrates far more that larger multicentre studies are required and appear promising to provide further evidence for the use of ciNPT.
  • Article
    Full-text available
    The risk for minor local complications for abdominoplasty remains high despite advances in strategies in recent years. The most common complication is the formation of seroma with reported rates ranging from 15% to 40%. The use of incisional negative-pressure wound therapy (iNPWT) on closed surgical sites has been shown to decrease the infection, dehiscence, and seroma rates. Thus, this article aims to determine whether an iNPWT dressing, Prevena Plus, is able to reduce postoperative drainage and seroma formation in patients who undergo abdominoplasty. Sixteen consecutive patients who underwent abdominoplasty by a single surgeon were dressed with standard dressings and iNPWT dressings. Total drain output, day of drain removal, and adverse events were compared between cohorts with a minimum follow-up of 6 months. The iNPWT group demonstrated a significantly less amount of fluid drainage with a mean total fluid output of 370 ± 275 ml compared to 1269 ± 436 ml mean total drainage from controls (P < 0.001). Time before removal of both drains was almost halved in the iNPWT group with an average of 5.3 ± 1.6 days, which was significantly less than the average time of 10.6 ± 2.9 days seen in control patients (P < 0.001). No observed adverse events were recorded in either group. Our findings show that iNPWT for a closed abdominoplasty incision decreases the rate of postoperative fluid accumulation and results in earlier drain removal.
  • Article
    Background: Over 30% of the US population is obese and nearly 300,000 patients undergo bariatric surgery every year. Patients seeking body-contouring procedures face a staggering rate of surgical complications caused by obesity-associated systemic and local factors impairing wound healing. Closed incision negative-pressure therapy (ciNPT) systems could improve surgical outcomes in these patients. Here, we tested this hypothesis in a retrospective case-control series of post-bariatric patients undergoing an abdominoplasty. Methods: We reviewed the clinical data of 11 post-bariatric patients (average BMI 34) who had undergone an abdominoplasty followed by either standard post-operative wound treatment (control) or ciNPT (at 125 mmHg for 8 days). Data (follow-up 90 days) was analyzed, measuring the time to heal of wounds (primary end-point), the rate of local surgical complications, and the quality of scars (Vancouver Scar Scale, VSS) (secondary endpoints). Results: No discomfort was associated with the use of ciNPT. Surgical wounds healed two times faster in patients treated with ciNPT compared to controls (time-to-dry: 10.8 ± 5 days vs. 23 ± 7). ciNPT was associated with a significantly lower rate of minor local complications (0%) compared to controls (80%), leading to shorter hospitalization, less dressing changes, and lower costs for the care of wounds with minor complications. One patient in the ciNPT group developed a major local complication (hematoma). The VSS demonstrated a higher quality of scars in the ciNPT group at a 90-day follow-up. Conclusions: ciNPT might reduce the rate of minor local complications in post-bariatric patients undergoing body-contouring procedures, improving surgical outcomes and treatment costs.
  • Article
    Introduction: The prevention of surgical site infections has received little attention in pediatric surgery. Negative pressure wound therapy is used to treat complex wounds. We hypothesized that this principle could reduce wound infection rates following laparoscopic surgery. We tested this in a randomized controlled trial. Materials and methods: We randomized pediatric patients with an umbilical port site to a standard dressing or a vacuum dressing. The dressings were removed 48h after surgery. A nurse blinded for the treatment inspected the umbilical wound between post-operative days 7-10 for infection. Data comparison was performed using a Fisher exact test with p<0.05 defined as significant. Results: We recruited 90 patients over 2 years and randomized 44 to the vacuum dressing arm and 42 to the control arm. We observed a 2.8% (n=1/35) infection rate in the vacuum dressing group and 3.3% (n=1/30) in the control group (p=1.0). Discussion: We ended our study early when an interim analysis showed an impractical number of patients would be required to achieve sufficient power. We did not find a significant difference between the control and vacuum dressings in reducing post-operative wound infections. Level of evidence: 3.
  • Article
    Full-text available
    Since its introduction in clinical practice in the early 1990's negative pressure wounds therapy (NPWT) has become widely used in the management of complex wounds in both inpatient and outpatient care.¹ NPWT has been described as a effective treatment for wounds of many different aetiologies2,3 and suggested as a gold standard for treatment of wounds such as open abdominal wounds,4–6 dehisced sternal wounds following cardiac surgery7,8 and as a valuable agent in complex non-healing wounds.9,10 Increasingly, NPWT is being applied in the primary and home-care setting, where it is described as having the potential to improve the efficacy of wound management and help reduce the reliance on hospital-based care.¹¹ While the potential of NPWT is promising and the clinical use of the treatment is widespread, highlevel evidence of its effectiveness and economic benefits remain sparse.12–14 The ongoing controversy regarding high-level evidence in wound care in general is well known. There is a consensus that clinical practice should be evidence-based, which can be difficult to achieve due to confusion about the value of the various approaches to wound management; however, we have to rely on the best available evidence. The need to review wound strategies and treatments in order to reduce the burden of care in an efficient way is urgent. If patients at risk of delayed wound healing are identified earlier and aggressive interventions are taken before the wound deteriorates and complications occur, both patient morbidity and health-care costs can be significantly reduced. There is further a fundamental confusion over the best way to evaluate the effectiveness of interventions in this complex patient population. This is illustrated by reviews of the value of various treatment strategies for non-healing wounds, which have highlighted methodological inconsistencies in primary research. This situation is confounded by differences in the advice given by regulatory and reimbursement bodies in various countries regarding both study design and the ways in which results are interpreted. In response to this confusion, the European Wound Management Association (EWMA) has been publishing a number of interdisciplinary documents15–19 with the intention of highlighting: • The nature and extent of the problem for wound management: from the clinical perspective as well as that of care givers and the patients • Evidence-based practice as an integration of clinical expertise with the best available clinical evidence from systematic research • The nature and extent of the problem for wound management: from the policy maker and healthcare system perspectives The controversy regarding the value of various approaches to wound management and care is illustrated by the case of NPWT, synonymous with topical negative pressure or vacuum therapy and cited as branded VAC (vacuum-assisted closure) therapy. This is a mode of therapy used to encourage wound healing. It is used as a primary treatment of chronic wounds, in complex acute wounds and as an adjunct for temporary closure and wound bed preparation preceding surgical procedures such as skin grafts and flap surgery. Aim An increasing number of papers on the effect of NPWT are being published. However, due to the low evidence level the treatment remains controversial from the policy maker and health-care system's points of view—particularly with regard to evidence-based medicine. In response EWMA has established an interdisciplinary working group to describe the present knowledge with regard to NPWT and provide overview of its implications for organisation of care, documentation, communication, patient safety, and health economic aspects. These goals will be achieved by the following: • Present the rational and scientific support for each delivered statement • Uncover controversies and issues related to the use of NPWT in wound management • Implications of implementing NPWT as a treatment strategy in the health-care system • Provide information and offer perspectives of NPWT from the viewpoints of health-care staff, policy makers, politicians, industry, patients and hospital administrators who are indirectly or directly involved in wound management.
  • Article
    Background The aim of this study was to determine whether negative pressure wound therapy, used prophylactically in clean surgical incisions, reduces surgical site infection (SSI), hematoma, and seroma after total joint replacement. Methods A single center, open-label study with a prospective cohort of patients undergoing primary total knee arthroplasty (TKA) or total hip arthroplasty (THA) treated with closed incision negative pressure therapy (ciNPT) of clean surgical wounds. 196 incisions treated with ciNPT in 192 patients were compared to a historical control group of 400 patients treated with traditional gauze dressing. The rates of clinically significant hematoma, seroma, dehiscence, SSI, and complication were compared using univariate analyses and multiple logistic regression. Results The rate of deep infection was unchanged in the ciNPT group compared to control (1.0% vs 1.25%), however the overall rate of infection (including superficial wound infection) decreased significantly (3.5% vs 1.0%, p=0.04) Overall complication rate was lower in the ciNPT group than controls (1.5% vs. 5.5%, p=0.02). Upon logistic regression, only treatment group was associated with complication; patients treated with ciNPT were about four times less likely to experience a surgical site complication compared to control (p=0.0277, OR=4.251 95% CI 1.172 – 15.414). Conclusions Closed incision negative pressure therapy for TKA and THA in a comprehensive patient population reduced overall incidence of complication, but did not significantly impact the rate of deep infection. Further research to determine clinical and economic advantages of routine use of ciNPT in total joint arthroplasty is warranted.
  • Article
    Background Wound healing complications and surgical site infections after groin incisions are common. Incision management systems (IMS), such as Prevena™ are well established in the daily routine to prevent such postoperative wound complications but randomized controlled studies are pending. Objective Can the incidence of wound healing complications and surgical site infections after groin incisions be reduced by the application of an IMS? Methods Presentation of the positive effects of the IMS as well as the largest currently available studies dealing with the benefits of IMS compared to conventional wound dressings. Portrayal of the AIMS trial, a prospective, multicenter, randomized clinical trial comparing the rate of wound healing complications and surgical site infections using an IMS vs. conventional wound dressings. Results Several studies suggest a clinical benefit of IMS regarding the rate of wound healing complications and surgical site infections. The interim results of the AIMS trial after inclusion of 190 out of the 204 test subjects confirm these findings for wound healing complications after groin incisions. No product-related complications could be assessed so far, furthermore a univariate analysis showed a significantly reduced rate of wound healing complications for patients with prior groin incisions using an IMS. Conclusion The available data of the presented studies as well as the interim results of the AIMS trial suggest a clinical benefit for the use of an IMS regarding a reduced rate of wound healing complications and surgical site infections after groin incisions.
  • Article
    Full-text available
    Introduction Surgical site infections (SSI) are the most frequent nosocomial infections in Germany and occur in approximately 10% of patients after lower extremity arterial revascularization. Due to the considerable consequences for the patient, the healthcare system and for the hospital, attention must be paid to avoid postoperative complications. Material and methods Prospective documentation of SSI based on the German hospital infection surveillance system (KISS) protocol of the National Reference Center for Surveillance of Nosocomial Infections for the indicator OP GC_EXT (arterial reconstruction – lower limb) before and after the introduction of a bundle of care. These measures included preoperative body washing with antimicrobial soap as well as the application of antiseptic nasal ointment, hair removal in the operating area with a so-called clipper and the preoperative skin antiseptic was changed from a purely alcoholic antiseptic to an alcohol-based antiseptic with remnant active substance (octenidine). Results From February 2015 to March 2017 the indicator OP GC_EXT was recorded in a total of 428 interventions, 195 before intervention (February 2015–March 2016 baseline) and 233 in the post-intervention phase. In the observation period 36 SSIs were registered, 22 from February 2015 to March 2016 and 14 in the post-intervention phase up to March 2017. The infection rate could be reduced by almost 50% (11.28% vs. 5.49%, p = 0.044, χ²-test). Conclusions The rate of SSIs can be significantly reduced by implementation of various evaluated preoperative, intraoperative and postoperative measures. This is an interdisciplinary and interprofessional approach, the success of which depends mainly on a consistently high compliance of implementation.
  • Article
    Deep sternal wound infection (DSWI) represents a dangerous complication that can follow open-heart surgery with median sternotomy access. Muscle flaps, such as monolateral pectoralis major muscle flap (MPMF), represent the main choices for sternal wound coverage and infection control. Negative pressure incision management system has proven to be able to reduce the incidence of these wounds' complications. PrevenaTM represents one of these incision management systems and we aimed to evaluate its benefits. A total of 78 patients with major risk factors that presented post-sternotomy DSWI following cardiac surgery was selected. Thrity patients were treated with MPMF and PrevenaTM (study group). Control group consisted of 48 patients treated with MPMF and conventional wound dressings. During the follow-up period, 4 (13%) adverse events occurred in the study group, whereas 18 complications occurred (37·5%) in the control group. Surgical revision necessity and mean postoperative time spent in the intensive care unit were both higher in the control group. Our results evidenced PrevenaTM system's ability in improving the outcome of DSWI surgical treatment with MPMF in a high-risk patient population.
  • Article
    Objective: Patients who develop sternal wound infections (SWI) following median sternotomy experience worse clinical outcomes and require longer and more costly care than patients without this complication. The majority of SWI in obese patients are triggered by the breakdown of skin sutures and subsequent seepage of skin flora. The purpose of this study was to evaluate negative pressure wound dressing treatment (NPWT) for the prevention of SWI. We hypothesized that NPWT for 6 – 7 days applied immediately after skin closure reduces the numbers of wound infections by skin flora. Methods: In a prospective study 177 consecutive obese patients (BMI ≥30) with cardiac surgery performed via median sternotomy were analyzed. In the NPWT group (n = 102) a foam dressing (Prevena™, KCI, Wiesbaden, Germany; therapy costs: 350€/patient) was placed immediately after skin suturing and negative pressure of -125 mmHg was applied for 6 to 7 days. In the control group (n = 75) conventional wound dressings were used. Primary endpoint was wound infection within 90 days. Wound infections were defined on the basis of the criteria of the US Centers for Disease Control and Prevention (CDC). Mann-Whitney U-test and Fisher's exact test were used. Results: Preoperative patient characteristics, comorbidities, SWI risk factors and procedure-related variables were comparable between NPWT group and control group (all p>.05). Four out of 102 (3.9%) patients with continuous NPWT suffered from wound infections compared to 12 out of 75 (16%) patients with conventional sterile wound dressing (p < 0.02). Wound infections with Gram positive skin flora were found in only one patient in the NPWT group compared to 10 patients in the control group (p < 0.01). Patients with SWI (n = 16) had to be treated by surgical debridement and secondary wound closure or by repeated revisions, including VAC therapy, resulting in an extended median overall length of hospital stay (32.5 d vs. 15.5 d) and additional therapy costs of about 9.000€ per case. Conclusions: Negative pressure wound therapy (NPWT) over clean, closed incisions for the first 6 to 7 postoperative days significantly reduces the incidence of wound infection after median sternotomy (from 16% to 3.9%) in this high-risk group of obese patients. Considering the reduction of SWI rate and the additional therapy costs caused by SWI, negative pressure wound therapy is also cost-effective in this high-risk group of patients.
  • Objective: The majority of wound infections after median sternotomy in obese patients are triggered by the breakdown of skin sutures and subsequent seepage of skin flora. The purpose of this study was to evaluate negative pressure wound dressing treatment for the prevention of infection. We hypothesized that negative pressure wound dressing treatment for 6 to 7 days applied immediately after skin closure reduces the numbers of wound infections. Methods: In a prospective study, 150 consecutive obese patients (body mass index ≥ 30) with cardiac surgery performed via median sternotomy were analyzed. In the negative pressure wound dressing treatment group (n = 75), a foam dressing (Prevena, KCI, Wiesbaden, Germany) was placed immediately after skin suturing, and negative pressure of -125 mm Hg was applied for 6 to 7 days. In the control group (n = 75), conventional wound dressings were used. The primary end point was wound infection within 90 days. Mann-Whitney U test and Fisher exact test were used. Freedom from infection was estimated by Kaplan-Meier analysis. Results: Three of 75 patients (4%) with continuous negative pressure wound dressing treatment had wound infections compared with 12 of 75 patients (16%) with conventional sterile wound dressing (P = .0266; odds ratio, 4.57; 95% confidence interval, 1.23-16.94). Wound infections with Gram-positive skin flora were found in only 1 patient in the negative pressure wound dressing treatment group compared with 10 patients in the control group (P = .0090; odds ratio, 11.39; 95% confidence interval, 1.42-91.36). Conclusions: Negative pressure wound dressing treatment over clean, closed incisions for the first 6 to 7 postoperative days significantly reduces the incidence of wound infection after median sternotomy in a high-risk group of obese patients.
  • Article
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    The purpose of this study was to evaluate the use of negative pressure wound therapy (NPWT) to improve wound healing after total hip arthroplasty (THA) and its influence on the development of postoperative seromas in the wound area. The study is a prospective randomised evaluation of NPWT in patients with large surgical wounds after THA, randomising patients to either a standard dressing (group A) or a NPWT (group B) over the wound area. The wound area was examined with ultrasound to measure the postoperative seromas in both groups on the fifth and tenth postoperative days. There were 19 patients randomised in this study. Ten days after surgery, group A (ten patients, 70.5 ± 11.01 years of age) developed seromas with an average size of 5.08 ml and group B (nine patients, 66.22 ± 17.83 years of age) 1.97 ml. The difference was significant (p = 0.021). NPWT has been used on many different types of traumatic and non traumatic wounds. This prospective, randomised study has demonstrated decreased development of postoperative seromas in the wound and improved wound healing.
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    The seismic network set up in the Hyblean Plateau (Southeastern Sicily) in the framework of the POSEIDON project is aimed at the seismic surveillance of the zone, and in particular the identification of faults with enhanced activity. The seismic activity as inferred from the records of the years 1994-1998 showed an apparent concentration of events in the zone between Augusta and Syracuse where important petrochemical facilities are present, with a resulting elevated secondary seismic risk. However, the heterogeneity in the distribution of events with respect to the time of day made us suspect that these seismicity maps are severely biased by artificial events, such as quarry explosions. We distinguished between tectonic earthquakes and quarry blasts by the inspection of waveforms of certain key stations, and by spectral analysis. As a general rule we found that the local tectonic microearthquakes are richer in high frequencies than the quarry blasts. All events which were identified as quarry blasts occurred during the daytime between 08:00 a.m. and 03:00 p.m. GMT and on weekdays from Monday to Friday. The aforementioned concentration of seismicity between Augusta and Syracuse disappeared when filtering out these events. Automatic discrimination was carried out in a straightforward way using Artificial Neural Networks (ANN) in a supervised classification. The application of the ANN to various test data sets gave a success of about 95%. This showed that our results obtained with a ‘visual’ discrimination are mathematically reproducible and not arbitrary.
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    Surgical-site infections are a very expensive complication in cardiac surgery. Thus, the total costs for coronary artery bypass grafting (CABG) surgery may substantially increase when a deep sternal wound infection (DSWI) occurs. This may be due to an extended length of stay (LOS), the need for additional surgical procedures, vacuum-assisted wound dressing and antibiotic therapy. This study compares the LOS in the hospital and on an intensive care unit (ICU) as well as the total costs for patients undergoing CABG depending upon the occurrence of a subsequent DSWI. A case-control study was performed. Total costs of DSWI cases were analysed and compared to patients undergoing CABG without DSWI. Inclusion criterion for cases was the development of a DSWI according to the CDC criteria during hospital stay after CABG. Two control patients without any signs or symptoms of an infection during hospital stay were matched to each case by (1) type of surgery according to their diagnosis-related group (DRG), (2) age +/-5 years, (3) gender and (4) duration of preoperative hospital stay +/-2 days, but at least as long as the time at risk of cases before infection. Between January 2006 and March 2008, 17 CABG patients with DSWI (cases) and 34 matched controls were included. The median overall costs of a CABG case were 36,261 Euro compared with 13,356 Euro per control patient without infection (p<0.0001). The median overall LOS was 34.4 days versus 16.5 days, respectively (p=0.0006). The median LOS on ICU was 6.3 days versus 5.3 days (no significant difference). DSWI represents an important economic factor for the hospital as they may almost triple the costs for patients undergoing CABG. Thus, appropriate infection control measures for the prevention of DSWI should be enforced.
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    Multiple patient comorbidities and environmental factors increase the risk of incisional wound complications. The literature suggests that negative pressure therapy (NPT) on clean closed surgical incisions may help reduce the risk of wound infections and other complications. In this case study, NPT was applied in the operating room to clean closed surgical wounds in four high-risk patients (two men, two women) following coronary artery bypass grafting using bilateral internal mammary arteries, transmetatarsal amputation, and abdominal hysterectomy. All wounds healed well. These results and currently available information suggest that prospective, randomized, controlled clinical studies to assess the safety, efficacy, and cost-effectiveness of NPT in the prevention of postoperative wound complications are warranted. In addition, if studies confirm the validity and reliability of the proposed patient grading system discussed, it may help guide use of NPT in postsurgical patients.
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    Sternal wound infection (SWI) remains a devastating complication after cardiac surgery, decreasing long-term and short-term survival. In treating documented SWI, negative pressure wound therapy (NPWT) reduces wound edema and time to definitive closure and improves peristernal blood flow after internal mammary artery (IMA) harvesting. The authors evaluated NPWT as a form of "well wound" therapy in patients at substantial risk for SWI based on existing risk stratification models. Records of 57 adult cardiac surgery patients (September 2006 to April 2008) were reviewed. After preoperative risk assessment, NPWT was instituted on the clean, closed sternotomy immediately after surgery and continued 4 days postoperatively. Adverse postoperative events, including SWI, need for readmission, and other complications, were documented. Mean age was 60.4 +/- 10 years, and 89.5% were male; 77.2% were obese (mean body mass index 35.3 +/- 6.7), 54.4% were diabetic, and 29 (50.9%) were both obese and diabetic. Coronary artery bypass (CAB) with single IMA was performed in 50.9% of the patients followed in frequency by combined CAB/valve, non-CAB surgery, and CAB with bilateral IMA. Estimated risk for SWI was 6.1 +/- 4%. All patients tolerated NPWT to completion. Thirty-day and in-hospital mortality was 1.8% and unrelated to DSWI. No treatment of SWI was required. In this high-risk cohort, 3 postoperative SWI cases were anticipated but may have been mitigated by NPWT. This is an easily applied and well-tolerated therapy and may stimulate more effective wound healing. Among patients with increased SWI risk, strong consideration should be given to NPWT as a form of "well wound" therapy.
  • Article
    Although the incidence of mediastinal wound infection in patients undergoing median sternotomy for cardiopulmonary bypass is less than 1%, its associated morbidity, mortality, and "cost" remain unacceptably high. There is considerable lack of consensus regarding the ideal operative treatment of complicated median sternotomy wounds. The aim of this article is to review the current preventive, diagnostic, and therapeutic techniques offered to patients with mediastinitis. We also propose a new classification for postoperative mediastinitis. Data from the English-language literature suggest that the type of mediastinitis and direct assessment of the mediastinum under general anesthesia are the main determinants of the nature of subsequent operative treatment. Wound debridement and removal of foreign materials are essential steps of whatever procedures are applied. Closed mediastinal irrigation can be successful in type I mediastinitis, whereas major reconstructive operation is probably the treatment of choice for patients with mediastinitis types II to V. Refinement of the current diagnostic tools and further evaluation of the benefits of primary sternal fixation in combination with a reconstructive procedure in mediastinitis types I to III could improve the outcome of this dreaded complication.
  • Article
    During 1992-2000, postoperative mediastinitis developed after 126 (1.32%) of 9557 consecutive cardiac surgery procedures. The study was done to describe the variation in clinical characteristics and microbiological etiology in mediastinitis. The records of 126 cases of postoperative mediastinitis were reviewed. The median time from operation to the development of mediastinitis was 7 days. Sternal dehiscence was seen in 86 patients (68%). Coagulase negative staphylococci (CNS) were isolated in 46% of the cases with a verified microbiological etiology, Staphylococcus aureus in 26% and gram-negative bacteria in 18%. CNS were more frequently isolated in patients with sternal dehiscence (44/80, 55%) than in patients with stable sternum (10/38, 26%) (P=0.003). However, S. aureus was more frequent in patients with stable sternum (18/38, 47%) than in patients with sternal dehiscence (13/80, 16%) (P<0.001). High body mass index was associated with coagulase negative staphylococci (P<0.001) and with sternal dehiscence (P=0.008). Chronic obstructive pulmonary disease was also associated with sternal dehiscence (P<0.001) and with coagulase negative staphylococci (P=0.04). Patients who had been reoperated before onset of mediastinitis tended to have an increased risk for a gram-negative etiology (32 vs. 15% in patients not reoperated, P=0.06). The overall 90-day all cause mortality in patients with mediastinitis was 19%. High age, need for reoperation before mediastinitis, and a long primary operation time was associated with increased mortality (P=0.02, P=0.007 and P=0.001, respectively). No specific bacterial etiology was associated with increased mortality nor was the presence of bacteriemia. Three different types of postoperative mediastinitis can be distinguished: (1) mediastinitis associated with obesity, chronic obstructive pulmonary disease, and sternal dehiscence, typically caused by coagulase negative staphylococci; (2) mediastinitis following peroperative contamination of the mediastinal space, often caused by S. aureus, and (3) mediastinitis mainly caused by spread from concomitant infections in other sites during the postoperative period, often caused by gram negative rods. The proposed classification of mediastinitis into three groups with different pathogenic mechanisms may be useful in understanding which prophylactic counter measures have the potentials to be effective in a given situation.
  • Article
    The purpose of our study was to compare vacuum-assisted suction drainage (VASD) to conventional wound management, in the treatment of poststernotomy osteomyelitis (SOM). We included a total of 42 patients that developed poststernotomy osteomyelitis and required open wound management, between 1998 and 2000, in this study. Twenty of these patients were treated by VASD and the other 22 by conventional wound management. The patients were well comparable with regards to age, presenting postoperative day, infecting organism and risk factors for osteomyelitis. This was a retrospective study. The patients treated by VASD had a significantly reduced treatment duration (mean 17.2+/-5.8 vs. 22.9+/-10.8 days, P=0.009) and total hospital stay (mean 27.2+/-6.5 vs. 33.0+/-11.0 days, P=0.03). Perioperative mortality was similar, with one early death in each group. We conclude from our experience in the treatment of 42 patients with poststernotomy osteomyelitis that VASD shortened wound healing and hospital stay and thus proved to be an excellent alternative to conventional open management of these wounds.
  • Article
    To evaluate the use of negative pressure wound therapy (NPWT) to augment healing of surgical incisions and hematomas after high-energy trauma. This study is a prospective randomized evaluation of NPWT in trauma patients, randomizing patients with draining hematomas to either a pressure dressing (group A) or a VAC (group B). Additionally, patients with calcaneus, pilon, and high-energy tibial plateau fractures were randomized to either a standard postoperative dressing or a VAC over the sutures. There were 44 patients randomized into the hematoma study. Group A drained a mean of 3.1 days, compared with only 1.6 days for group B. This difference was significant (p=0.03). The infection rate for group A was 16%, compared with 8% in group B. An additional 44 patients have been randomized into the fracture study. Again, a significant difference (p=0.02) was present when comparing drainage in group A (4.8 days) and group B (1.8 days). No significant difference was present at current enrollment for infection or wound breakdown. NPWT has been used on many complex traumatic wounds. Potential mechanisms of action include angiogenesis, increased blood flow, and decreased interstitial fluid. This ongoing randomized study has demonstrated decreased drainage and improved wound healing following both hematomas and severe fractures.