Article

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

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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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... 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. ...
... 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. Although larger, randomized, controlled studies will help to clarify the precise role and benefits of such a system in cardiac surgery, the limited initial evidence from clinical studies [6][7][8][9][10] and from the authors' own experiences appears promising. ...
... In various surgical disciplines [4][5][6][7][8][9][10], randomized controlled trials, retrospective studies and case series provide a substantial body of evidence that the use of NPWT, either on a therapeutic or preventive basis, may reduce the incidence of complications in a variety of surgical wound types. To date, evidence for the benefits of NPWT in preventing wound complications after cardiac surgery has accumulated as well [6][7][8][9][10]. ...
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.
... In 2006, Stannard et al. introduced closed-incision NPWT (ciNPT) for use on closed surgical incisions to prevent wound dehiscence and to aid healing by primary intention (3). Meanwhile, several case series and retrospective studies have demonstrated that ciNPT is effective in reducing the postoperative infection rate in problematic wounds, especially in cardiac (4,5), orthopaedic (6), gynaecological (7)(8)(9) and general surgical wounds (10,11). Grauhan et al. reported that obese patients with median sternotomy for cardiac surgery treated with ciNPT had a significantly lower SSI rate compared to patients treated with conventional wound dressing (4% versus 16%; P = 0⋅0266) (5). ...
... Meanwhile, several case series and retrospective studies have demonstrated that ciNPT is effective in reducing the postoperative infection rate in problematic wounds, especially in cardiac (4,5), orthopaedic (6), gynaecological (7)(8)(9) and general surgical wounds (10,11). Grauhan et al. reported that obese patients with median sternotomy for cardiac surgery treated with ciNPT had a significantly lower SSI rate compared to patients treated with conventional wound dressing (4% versus 16%; P = 0⋅0266) (5). Comparing ciNPT and conventional dressing after femoral cutdown for vascular surgery, Matatov et al. observed a significant reduction of groin wound infections in the ciNPT group compared to historical controls (6% versus 30%; P = 0⋅0011) (2). ...
... A decade ago, Stannard et al. introduced NPWT as protection for problematic closed surgical incisions as well (3). Since then, ciNPT has been applied on a variety of problematic surgical wounds, including sternotomy for cardiac surgery (4,5), abdominal hernia repair (10,11), caesarean section (7-9), trauma (6) and vascular surgery (2,14,15). In general, most of the case series and retrospective studies observed a decreased rate of surgical site occurrences (SSO), including SSIs and wound dehiscence. ...
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.
... 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. ...
... As características metodológicas dos artigos incluídos foram semelhantes em cinco deles: A1 (17) ; A3 (19) ; A5 (21) ; A6 (22) ; A7 (23) -delineamento observacional -, e dois, A2 (18) e A4 (20) , foram ensaios clínicos randomizados (Quadro 2). ...
... Terapia de feridas por pressão negaTiva A utilização de terapia de feridas por pressão negativa (TFPN) foi proposta em quatro artigos (50% da amostra da pesquisa), sendo que A1 (17) , A5 (21) e A6 (22) citaram o dispositivo Prevena™ -Incision Management System, e A7 (23) não revelou a marca utilizada. ...
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.
... Several clinical studies have shown that external suction (closed incision negative-pressure therapy, ciNPT) can accelerate closure of surgical wounds in patients at high risk for impaired/delayed healing and can significantly reduce the rate of local complications [22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41]. ...
... This is the first case-control series investigating the use of ciNPT in these patients [22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40]. Our outcomes are consistent with those reported for other clinical conditions, highlighting the capacity of ciNPT to reduce the rate of post-operative complications in high-risk patients [22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41]. ...
... This is the first case-control series investigating the use of ciNPT in these patients [22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40]. Our outcomes are consistent with those reported for other clinical conditions, highlighting the capacity of ciNPT to reduce the rate of post-operative complications in high-risk patients [22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41]. In comparison to our control group (representative of literature), the reduction in minor local complications is striking [13][14][15][16][17][18][19][20]. ...
Article
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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.
... Significantly lower rates of infection were reported in the ciNPT group compared to the control group [5]. Grauhan et al. [15] followed up this research with a further trial looking at the effect of ciNPT in a general population of post-sternotomy patients (n = 237) compared to a historical cohort that received conventional dressings (n = 3508). The authors found the ciNPT group had a significantly lower infection rate compared to the historical control group [15]. ...
... Grauhan et al. [15] followed up this research with a further trial looking at the effect of ciNPT in a general population of post-sternotomy patients (n = 237) compared to a historical cohort that received conventional dressings (n = 3508). The authors found the ciNPT group had a significantly lower infection rate compared to the historical control group [15]. The authors found that the ciNPT group had a significantly lower infection rate compared to the historical group (1.3% for ciNPT vs. 3.4% for control; P ≤ 0.05) [15]. ...
... The authors found the ciNPT group had a significantly lower infection rate compared to the historical control group [15]. The authors found that the ciNPT group had a significantly lower infection rate compared to the historical group (1.3% for ciNPT vs. 3.4% for control; P ≤ 0.05) [15]. In our study, ciNPT had a lower infection rate among patients with 2 or more risk factors Our results appear to match those reported in the current published literature. ...
Article
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Background: Sternal wound infection (SWI) following cardiothoracic surgery is a major complication. It may significantly impact patient recovery, treatment cost and mortality rates. No universal guideline exists on SWI management, and more recently the focus has become prevention over treatment. Recent studies report positive outcomes with closed incision negative pressure therapy (ciNPT) on surgical incisions, particularly for patients at risk of poor wound healing. Objective: This study aims to assess the effect of ciNPT on SWI incidence in high-risk patients. Methods: A retrospective study was performed to investigate the benefit of ciNPT post sternotomy. Patients 3 years before the introduction of ciNPT (Control group) and 3 years after ciNPT availability (ciNPT group) were included. Only patients that had two or more of the risk factors; obesity, Chronic Obstructive Pulmonary Disease, old age and diabetes mellitus in the High Risk ciNPT cohort were given the ciNPT dressing. Patient demographics, EuroSCOREs and length of staywere reported as mean ± standard deviation. The Fisher's exact test (two-tailed) and an unpaired t-test (two-tailed) were used to calculate the p-value for categorical data and continuous data, respectively. Results: The total number of patients was 1859 with 927 in the Control group and 932 in the ciNPT group. No statistical differences were noted between the groups apart from the Logistic EuroSCORE (Control = 6.802 ± 9.7 vs. ciNPT = 8.126 ± 11.3; P = 0.0002). The overall SWI incidence decreased from 8.7 to 4.4% in the overall groups with the introduction of ciNPT (P = 0.0005) demonstrating a 50% reduction. The patients with two and above risk factor in the Control Group (High Risk Control Group) were 162 while there was 158 in the ciNPT Group (High Risk ciNPT Group). The two groups were similar in all characteristics. Although the superficial and deep sternal would infections were higher in the High Risk Control Group versus the High Risk ciNPT group patients (20(12.4%) vs 9(5.6%); P = 0.049 respectively), the length of postoperative stay was similar in both (13.0 ± 15.1 versus 12.2 ± 15.6 days; p + 0.65). However the patients that developed infections in the two High Risk Groups stayed significantly longer than those who did not (25.5 ± 27.7 versus 12.2 ± 15.6 days;P = 0.008). There were 13 deaths in Hospital in the High Risk Control Group versus 10 in the High Risk ciNPT Group (P = 0.66). Conclusion: In this study, ciNPT reduced SWI incidence post sternotomy in patients at risk for developing SWI. This however did not translate into shorter hospital stay or mortality.
... Therefore, the authors concluded that application of ciNPWT decreases the postoperative wound infection rate in patients following median sternotomy (level III) [55]. The same authors published another study a year thereafter [56], prospectively evaluating 237 patients with median sternotomy and application of ciNPWT for 6-7 days. This group of patients was compared to a historic cohort of 3508 patients who had been treated with standard dressings [56]. ...
... The same authors published another study a year thereafter [56], prospectively evaluating 237 patients with median sternotomy and application of ciNPWT for 6-7 days. This group of patients was compared to a historic cohort of 3508 patients who had been treated with standard dressings [56]. Primary endpoint was sternal wound infection during the first 30 postoperative days. ...
... Primary endpoint was sternal wound infection during the first 30 postoperative days. Patients in the ciNPWT group developed significantly fewer sternal wound infections (1.3% vs. 3.4%; p < 0.05; odds ratio: 2.74) in comparison to the control group, which is why the authors concluded that ciNPWT significantly reduces deep sternal wound infections following median sternotomy (level III) [56]. In the same year, the first randomized controlled trial was published by Witt-Majchrzak et al. [57], analysing 80 patients after sternotomy for open heart surgery. ...
Article
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Background Wound healing deficits and subsequent surgical site infections are potential complications after surgical procedures, resulting in increased morbidity and treatment costs. Closed-incision negative-pressure wound therapy (ciNPWT) systems seem to reduce postoperative wound complications by sealing the wound and reducing tensile forces. Materials and methods We conducted a collaborative English literature review in the PubMed database including publications from 2009 to 2020 on ciNPWT use in five surgical subspecialities (orthopaedics and trauma, general surgery, plastic surgery, cardiac surgery and vascular surgery). With literature reviews, case reports and expert opinions excluded, the remaining 59 studies were critically summarized and evaluated with regard to their level of evidence. Results Of nine studies analysed in orthopaedics and trauma, positive results of ciNPWT were reported in 55.6%. In 11 of 13 (84.6%), 13 of 15 (86.7%) and 10 of 10 (100%) of studies analysed in plastic, vascular and general surgery, respectively, a positive effect of ciNPWT was observed. On the contrary, only 4 of 12 studies from cardiac surgery discovered positive effects of ciNPWT (33.3%). Conclusion ciNPWT is a promising treatment modality to improve postoperative wound healing, notably when facing increased tensile forces. To optimise ciNPWT benefits, indications for its use should be based on patient- and procedure-related risk factors.
... 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. ...
... In the observational studies, the use of pNPWT was based on the surgeons decision in 6 studies [ (before-after) in 8 studies. [24,25,28,29,31,[34][35][36] The evidence table with more detailed information is in Table 1. ...
... We found 9 studies on abdominal surgery [19,[26][27][28]36] of which 4 involved ventral hernia repair procedures, [29,30,32,34] 6 studies in orthopaedic or trauma surgery [9,21,22,25,33] 2 studies in cardiac surgery, [24,35] and 2 studies in vascular surgery. One study [20] included both abdominal and breast surgery. ...
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.
... [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. ...
... and a retrospective medical record review of 237 sternotomy patients compared with 3508 historical control patients.19 Patient demographics ...
Article
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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.
... 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). ...
... When stratified by type of surgery, this effect was observed in abdominal (nine observational studies; [132][133][134][135][136]140,141,143,144 OR 0·31; 0·19-0·49) and cardiac (two observational studies; 137,138 OR 0·29; 0·12-0·69) surgery, but it was not statistically significant in orthopaedic or trauma surgery. Stratification by wound contamination class showed a significant benefit in reducing SSI prevalence with the use of pNPWT in clean surgery (eight observational studies; 131,135,[137][138][139]141,142,144 OR 0·27; 95% CI 0·17-0·42) and in clean-contaminated surgery (eight observational studies; [132][133][134]136,140,141,143,144 OR 0·29; 0·17-0·50). ...
Article
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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.
... 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]. ...
... Data exist showing a decrease in SSI with ciNPT as compared to traditional surgical dressings in individual studies [5][6][7][8][9][10][11]14]. Based on these data, international multi-disciplinary consensus recommendations were published regarding ciNPT best-use practices [15]. ...
Article
Negative pressure wound therapy (NPWT) has revolutionized wound care. Negative pressure therapy (NPT) is now being applied to closed incisions. Closed-incision NPT (ciNPT) management systems apply negative pressure to the incision and structurally stabilize the surrounding tissues. They are thought to be helpful in high-risk surgical closure. Patients with large sarcomas that have been previously radiated are considered to be among the highest risk for postoperative wound complications. We share our experience with ciNPT in two patients after resection of large, previously irradiated invasive sarcomas. In both cases, healing was uncomplicated. ciNPT shows promise of effective and favorable wound healing in early case reports. Additional prospective randomized clinical trials or registry studies will be necessary to provide higher levels of evidence for this technique.
... 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. ...
... Previous research includes a retrospective analysis that used historic controls and demonstrated a much larger risk reduction (OR 0.28, P < 0.05). 18 However, this industry-funded study was not risk-adjusted and had a very large time bias. Another study by the same group, and also industry funded, was a randomized trial in high-risk obese patients. ...
... 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). ...
... In order to optimise the advancement of preventive procedures, the effectiveness of ciNPT on groin wounds after vascular surgeries was evaluated. The effect of ciNPT has been demonstrated in clinical studies and case reports in a variety wound types (27)(28)(29)(30)(31)(32)(33)(34)(35)(36)(37). In spite of many publications, clinical studies involving groin wounds are rare. ...
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.
... 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. ...
... 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. Matatov and colleagues [35] noted that for their vascular surgery patients, none required an extended hospital stay or care for SSI, suggesting cost savings with ciNPT use compared to the >$45,000 costs for infection care and extended hospital stay for two control patients with Szilagyi grade III infection. ...
Article
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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.
... 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]. ...
... Results have shown no wound complications in this high-risk group of patients at least 30 days after surgery and complete wound and surrounding skin healing with the absence of skin lesion due to negative pressure after removal of the dressing [68]. Results from another study also concluded that applying incisional NPWT over clean, closed incisions for the first 6-7 postoperative days reduced the likelihood of postoperative wound infections after median sternotomy not only in high-risk patients but also in a comprehensive patient population [45]. ...
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.
... 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. ...
... Use of ciNPT has been utilized with positive clinical benefit in a variety of surgical incision types. [6][7][8][9][10][11][12] This meta-analysis assessed the impact of a single ciNPT device use on SSI rates in vascular surgery with groin incision compared to traditional postsurgical dressings in RCTs. The systematic review identified six RCTs for analysis. ...
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Objective: 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. Methods: A systematic literature search using PubMed, OVID, EMBASE, and QUOSA was performed on 3 January 2019, by two independent researchers and focused on publications between 1 January 2005 and 31 December 2018. The review conformed to the statement and reporting check list of the Preferred Reporting Items for Systematic Reviews and Meta Analyses. Inclusion criteria included abstract or manuscript written in English, published studies, conference abstracts, randomized controlled trials (RCTs), ciNPT usage over closed groin incisions in vascular surgery, comparison of ciNPT use and traditional dressings, study endpoint/outcome of surgical site infection, and study population of >10. Characteristics of study participants, surgical procedure, type of dressing used, duration of treatment, incidence of surgical site infection, and length of follow-up were extracted. Weighted odds ratios and 95% confidence intervals were calculated to pool study and control groups in each publication for analysis. Treatment effects were combined using Mantel-Haenszel risk ratios, and the Chi-Square test was used to assess heterogeneity. Overall, high-risk patients, normal-risk patients, and Szilagyi I, II, III outcomes were assessed between ciNPT and control groups. The Cochrane Collaboration tool was utilized to assess the risk of bias for all studies included in the analysis. Results: A total of 615 articles were identified from the literature search. After removal of excluded studies and duplicates, six RCT studies were available for analysis. In these studies, a total of 362 patients received ciNPT, and 371 patients received traditional dressings (control). Surgical site infection events occurred in 41 ciNPT patients and 107 control patients. The heterogeneity test was nonsignificant (p > 0.05). The overall RCT meta-analysis showed a highly significant effect in favor of ciNPT (OR = 3.06, 95% CI [2.05, 4.58], p < 0.05). High-risk, normal-risk, Szilagyi I, and Szilagyi II meta-analyses were also statistically significant in favor of ciNPT use (p < 0.05). The varying RCT inclusion/exclusion criteria, such as differences in procedure types, and patient populations form the major limitations of this study. Conclusions: A statistically significant reduction in the incidence of surgical site infection was seen following ciNPT usage in patients undergoing vascular surgery with groin incisions.
... Sample size calculation was based on previously reported differences in the occurrence of wound infections among patients treated with and without Prevena IMS, which were used to estimate the possible range of plausible treatment effect.These have not been used for estimating proportions in the control group; here informal estimates of proportions have been applied. 8,14 The differences between the treatment groups were calculated using a type 1 error of 0.05, power of 0.8, and a two tailed Fisher's test as modified by Boschloo test. 15 With an expected outcome of 3% in the intervention group and a treatment difference of 0.14 (17% outcome in the control group), the required sample size was 71 patients per treatment group. ...
Article
Background: Surgical site infections of the groin remain a crucial problem in vascular surgery, prompting great interest in preventative techniques, such as closed incision negative pressure therapy (ciNPT). This prospective randomised study aimed to assess the potential benefits of ciNPT application after groin incisions for vascular surgery. Method: The study included 204 patients who underwent vascular surgery for peripheral artery disease (PAD) at two sites between July 2015 and May 2017. These patients received post-operative treatment with ciNPT (intervention group) or standard wound dressings (control group). After exclusion, 188 patients were assessed for SSIs using the Szilagyi classification. Results: The mean patient age was 66.6 ± 9.4 years (range 43-85 years), and 70% were male (n = 132). Regarding PAD stage, 52% were stage IIB, 28% stage III, and 19% stage IV. Among the patients, 45% (n = 85) had had a previous groin incision. Bacterial swabs were performed in each case of suspected SSI (22.8% [43/188]), while 76.7% (33/188) were negative, there were 5% [5/98] positive swabs in the intervention group and 5.5% [5/90] in the control group). Antibiotics were given to 13.2% of the intervention group, and 31.1% of the control group (p = .004). The control group experienced more frequent SSIs (33.3%; 30/90) than the intervention group (13.2%; 13/98; p = .0015; absolute risk difference -20.1 per 100; 95% CI -31.9 to 8.2). This difference was based on an increased rate of Szilagyi I SSI in the control group (24.6% vs. 8.1%, p = .0012). Conclusion: The results confirmed a reduced superficial SSI rate after vascular surgical groin incision using ciNPT compared with standard wound dressings.
... 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. ...
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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.
... 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
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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.
... 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
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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.
... Utility of negative wound pressure therapy has been described in complicated wounds' management (21)(22)(23), such as in DSWI (24,25). ...
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.
... [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
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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.
... 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
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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.
... 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
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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.
... In recent years, there have been multiple studies comparing the use of PREVENA Therapy to conventional dressings in the management of surgical wounds, particularly in the setting of vascular surgeries, post-caesarean infections and colorectal resections [14][15][16][17][18][19]. To date, there is a lack of evidence to support the routine use of NPWT or PREVENA Therapy in the setting of stoma reversal. ...
Article
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Aim There is a current lack of evidence in the literature to support the routine use of negative pressure wound therapy (NPWT) to reduce the risk of surgical site infections (SSI) in the setting of ileostomy or colostomy reversal. The aim of this study is to examine whether routine NPWT confers a lower rate of SSI than conventional dressings following reversal of ileostomy or colostomy. Methods The PRIC study is a randomized, controlled, open-label, multi-centre superiority trial to assess whether routine NPWT following wound closure confers a lower rate of SSI following reversal of ileostomy or colostomy when compared to conventional dressings. Participants will be consecutively identified and recruited. Eligible participants will be randomized in a 1:1 allocation ratio, to receive either the NPWT (PREVENA) dressings or conventional dressings which will be applied immediately upon completion of surgery. PREVENA dressings will remain applied for a duration of 7 days. Surgical wounds will then be examined on post-operative day seven as well as during follow-up appointments in OPD for any evidence of SSI. In the interim, public health nurses (PHN) will provide out-patient support services incorporating wound assessment and care as part of a routine basis. Study investigators will liaise with PHN to gather the relevant data in relation to the time to wound healing. Our primary endpoint is the incidence of SSI within 30 days of stoma reversal. Secondary endpoints include measuring time to wound healing, evaluating wound healing and aesthetics and assessing patient satisfaction. Conclusion The PRIC study will assess whether routine NPWT following wound closure is superior to conventional dressings in the reduction of SSI following reversal of ileostomy or colostomy and ascertain whether routine NPWT should be considered the new standard of care.
... 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]. ...
... In addition to the application of diverse surgical techniques and systemic antibiotic therapy, the treatment of a broad spectrum of WHCs has been enhanced by negative pressure wound therapy (NPWT), which has been proven to be effective in a wide range of wounds [11][12][13][14][15]. In recent years a new form of therapy, known as closed incision negative pressure therapy (ciNPT), has resulted in a decreasing rate of SSIs in various incision wounds [5][6][7][8][9][10][16][17][18][19][20][21][22][23][24]. The two leading ciNPT systems responsible for these significant effects are PREVENA™ Incision Management Therapy System (KCI, an ACELITY Company, San Antonio, Texas, USA) and PICO™ Single Use Negative Pressure Wound Therapy System (Smith & Nephew, London, UK). ...
... Prophylactic closed NPWT, e.g., Prevena (KCI) or PICO (Smith and Nephew), help keep wound edges together to avoid dehiscence, reduce lateral tension and oedema, increase tissue perfusion, stimulate granulation tissue formation, reduce bacterial colonisation and isolate the wound from potential contaminating sources. In one prospective study [170,171] with obese patients, the use of NPWT was compared prophylactically on clean incisions. A second study [165] included more than 200 patients with sternotomy. ...
Article
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This is a consensus document of the Spanish Society of Cardiovascular Infections (SEICAV), the Spanish Society of Thoracic and Cardiovascular Surgery (SECTCV) and the Biomedical Research Centre Network for Respiratory Diseases (CIBERES). These three entities have brought together a multidisciplinary group of experts that includes anaesthesiologists, cardiac and cardiothoracic surgeons, clinical microbiologists, infectious diseases and intensive care specialists, internal medicine doctors and radiologists. Despite the clinical and economic consequences of sternal wound infections, to date, there are no specific guidelines for the prevention, diagnosis and management of mediastinitis based on a multidisciplinary consensus. The purpose of the present document is to provide evidence-based guidance on the most effective diagnosis and management of patients who have experienced or are at risk of developing a post-surgical mediastinitis infection in order to optimise patient outcomes and the process of care. The intended users of the document are health care providers who help patients make decisions regarding their treatment, aiming to optimise the benefits and minimise any harm as well as the workload.
... 15,16 In addition, incisional negative pressure wound therapy (iNPWT) has been used to prevent infections after open-heart surgery with mostly promising results. [17][18][19][20] Recently, there have been a few reports of using iNPWT after pectoralis major muscle flap reconstruction in the treatment of DSWI to prevent flaprelated surgical complications. 10,21,22 Most of the studies concerning the use of NPWT and iNPWT have been relatively small retrospective studies with heterogeneity, possibility for publication bias, and the matter of manufacturer involvement to discuss. ...
Article
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Background and objective Deep sternal wound infection is a feared complication of open-heart surgery. Negative pressure wound therapy has gained an important role in the treatment of deep sternal wound infection. Incisional negative pressure wound therapy has been introduced as a method to prevent wound complications after sternotomy, and lately, after flap reconstructions in the treatment of deep sternal wound infection. We aimed to study if incisional negative pressure wound therapy with PICO™ had similar beneficial effect described earlier with competing commercial devices. Methods This study included 82 patients treated with pectoralis major muscle flap for deep sternal wound infection during the years 2006–2020. PICO group consisted of 24 patients treated with preoperative negative pressure wound therapy and postoperative incisional negative pressure wound therapy (PICO™). Two control groups included 48 patients with conventional treatment and 10 patients with preoperative negative pressure wound therapy only. Results In the PICO group, the complication rate declined from 50.0% to 33.30%, major complication rate from 29.2% to 12.5%, and need for an additional flap from 14.6.% to 4.2% when compared to conventional treatment. The length of hospital stay decreased as well. Preoperative negative pressure wound therapy alone was associated with moderate decline in the complication rates. In addition, we described the use of split pectoralis major muscle flap reconstruction in 57 patients. To our knowledge, this is the largest published patient series describing this method in the treatment of deep sternal wound infection. Conclusions Incisional negative pressure wound therapy with PICO™ seems beneficial after flap reconstruction. Split pectoralis major muscle flap is a versatile reconstruction option suitable to be used as a workhorse in the treatment of deep sternal wound infection.
... 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
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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.
... 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
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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.
Article
Use of negative-pressure therapy (NPT) is a well-established therapy for chronic, open, contaminated wounds, promoting formation of granulation tissue and healing. The application of NPT after primary closure (ie, incisional NPT) has also been shown to reduce surgical site infection and surgical site occurrence in high-risk procedures across multiple disciplines. Incisional NPT is believed to decrease edema and shear stress, promote angiogenesis and lymphatic drainage, and increase vascular flow and scar formation. Incisional NPT may be considered when there is a high risk of surgical site occurrence or surgical site infection, particularly in procedures with nonautologous implants, such as hernia mesh or other permanent prosthetics. Here we discuss the proposed physiologic mechanism as demonstrated in animal models and review clinical outcomes across multiple specialties.
Technical Report
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Evidence-based recommendations on pre-operative measures for the prevention of surgical site infection
Article
Background Incisional negative pressure wound therapy has been described as an effective method to prevent wound infections after open heart surgery in several publications. However, most studies have examined relatively small patient groups, only a few were randomized, and some have manufacturer-sponsorship. Most of the studies have utilized Prevena; there are only a few reports describing the PICO incisional negative pressure wound therapy system. Methods We conducted a prospective cohort study involving a propensity score-matched analysis to evaluate the effect of PICO incisional negative pressure wound therapy after coronary artery bypass grafting. A total of 180 high-risk patients with obesity or diabetes were included in the study group. The control group included 772 high-risk patients operated before the initiation of the study protocol. Results The rates of deep sternal wound infections in the PICO group and in the control group were 3.9 and 3.1%, respectively. The rates of superficial wound infections needing operative treatment were 3.1 and 0.8%, respectively. After propensity score matching with two groups of 174 patients, the incidence of both deep and superficial infections remained slightly elevated in the PICO group. None of the infections were due to technical difficulties or early interruption of the treatment. Conclusion It seems that incisional negative pressure wound therapy with PICO is not effective in preventing wound infections after coronary artery bypass grafting. The main difference in this study compared with previous reports is the relatively low incidence of infections in our control group.
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.
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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
Learning objectives: After reading this article, the participant should be able to: 1. Understand the basics of negative-pressure wound therapy and practical uses of various vacuum-assisted closure dressings. 2. Understand the mechanisms of action of negative-pressure therapies and other important adjuncts, such as perfusion imaging. 3. Discuss the evidence for hyperbaric oxygen therapy in wound care. Summary: Wound healing requires creating an environment that supports the healing process while decreasing inflammation and infection. Negative-pressure wound therapy has changed the way physicians manage acute and chronic wounds for more than 20 years. It contracts wound edges, removes exudate, including inflammatory and infectious material, and promotes angiogenesis and granulation tissue formation. These effects have been consistently demonstrated in multiple animal and human randomized controlled trials. Recent innovations that include instillation therapy and closed incision have further increased our arsenal against difficult-to-treat wounds and incisions at high risk of complications. Instillation of topical wound solutions allows physicians to cleanse the wound without return to the operating room, resulting in fewer debridements, shorter hospital stays, and faster time to wound closure. Other concepts have yielded negative-pressure therapy on top of closed surgical incisions, which holds incision edges together, reduces edema, promotes angiogenesis, and creates a barrier to protect incisions during the critical healing period, thereby reducing surgical-site complications, especially infection. Other practical adjuncts to the modern-day treatment of acute and chronic wounds include indocyanine green angiography, which allows real-time assessment of perfusion, and hyperbaric oxygen treatment, which has been suggested to augment healing in acute, chronic, specifically diabetic foot ulcers and radiation-related wounds.
Article
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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
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
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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.
Book
This concise and practical handbook covers the basics of pathophysiology, diagnosis, interdisciplinary surgical management, prevention and rehabilitation of patients with deep sternal wound infections and sternal osteomyelitis. All relevant aspects and surgical procedures are explained in an easily understandable way. Additionally special approaches and preventive measures are highlighted with regard to the perioperative handling as well as the rehabilitation possibilities. Through concise texts with numerous illustrations, the book is ideal for the practice and as a supplement to further studies. This book is suitable for all specialists who are involved into the treatment and diagnosis of sternal wound infections, particularly cardio-thoracis, thoracic, plastic, vascular surgeons, cardiologists, radiologists, and rehabilitation physicians.
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
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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: Surgical site infections (SSIs) pose a significant surgical complication. Application of closed-incision negative-pressure therapy (ciNPT) has been associated with reduced SSI rates in published literature. This meta-analysis examines the effect of ciNPT use over closed incisions in reducing SSIs versus traditional dressings. METHODS: A systematic literature search using PubMed, The Cochrane Library, OVID, EMBASE, ScienceDirect, and QUOSA was performed focusing on publications between January 1, 2005, and April 30, 2018. Characteristics of study participants, surgical procedure, type of dressing used, duration of treatment, incidence of SSI, and length of follow-up were extracted. Weighted odds ratios and 95% CIs were calculated to pool study and control groups in each publication for analysis. Treatment effects were combined using Mantel-Haenszel odds ratios as the summary statistics, and a fixed-effects model was used for each analysis performed. The chi-square test was used to statistically assess heterogeneity. For each meta-analysis performed, the more conservative random-effects models were conducted as sensitivity analyses. RESULTS: For all meta-analyses (randomized controlled trial only, observational studies only, colorectal/abdominal, obstetrics, lower extremity, groin/vascular, cardiac), heterogeneity tests were nonsignificant (P > 0.05). All fixed-effects meta-analyses were significant in favor of ciNPT use over traditional dressings (P < 0.05). When the random-effects analyses were performed, all analyses except obstetrics remained significant (P < 0.05). CONCLUSION: For all meta-analyses performed using the fixed-effects approach, ciNPT usage demonstrated a statistically significant reduction in incidence of SSI relative to traditional dressings.
Article
Background: Sternal wound infections are a rare but life-threatening complication of cardiothoracic surgery. Prior literature has supported the use of negative pressure wound therapy to decrease sternal wound infections and promote healing. This study sought to determine whether closed incision negative pressure therapy reduced wound infection and improved outcomes in cardiothoracic surgery. Methods: A retrospective cohort study was performed including all adult patients who underwent nontraumatic cardiothoracic surgery at a single institution between 2016 and 2018 (n = 1199). Patient characteristics, clinical variables, and surgical outcomes were compared between those who did and did not receive incisional negative pressure wound therapy intraoperatively. Multivariable logistic regression analysis determined factors predictive or protective of the development of complications. Results: Incisional negative pressure wound therapy was used in 58.9% of patients. Patients who received this therapy were older with statistically higher rates of hyperlipidemia, statin, and antihypertensive use. The use of negative pressure wound therapy was found to significantly reduce rates of both wound infection (3.0% vs 6.3%, P = 0.01) and readmission for wound infection (0.7% vs 2.6%, P = 0.01). After controlling for confounding variables, negative pressure wound therapy was found to be a protective factor of surgical wound infection (odds ratio, 0.497; 95% confidence interval, 0.262-0.945). Conclusions: In the largest population studied to date, this study supported the expanded use of negative pressure therapy on sternal wound incisions to decrease infection rates.
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.
Article
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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.
Article
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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.
Article
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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.
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.
Article
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
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.