Closed incision negative pressure wound therapy may decrease wound complications in major lower extremity amputations.

OBJECTIVE: Wound complications after major lower extremity amputations (LEAs) are a cause of significant morbidity in vascular surgery patients. Recent publications have demonstrated the efficacy of the closed incision negative pressure dressing at preventing surgical site infections (SSIs); however, there are few data on its use in major LEAs. This study sought to assess if closed incision negative pressure wound therapy (NPWT) would decrease the risk of complications as compared with a standard dressing in patients with peripheral vascular disease undergoing major LEA. METHODS: Fifty-four consecutive patient limbs with a history of peripheral arterial disease underwent below-knee or above-knee amputations. This was a retrospective review of a prospectively maintained database from January 2018 to December 2019, and it included 23 amputations in the NPWT group and 31 amputations in the standard dressing group. NPWT using the PREVENA system was applied intraoperatively at the discretion of the operating surgeon and removed 5 to 7 days postoperatively. The standard group received a nonadherent dressing with an overlying compression dressing. Amputation incisions were assessed and wound complications were recorded. Student's t-test and two-sample proportion z-test were used for statistical analysis. A P value of less than .05 was considered statistically significant. RESULTS: For comorbidities, there was a higher incidence of tobacco use in the NPWT as compared with the standard group (44% vs 13%; P = .011), as well as trends toward increased prior amputations, anemia, hyperlipidemia, and chronic obstructive pulmonary disorder in the NPWT group. For risk factors, there were more dirty wounds in the NPWT as compared with the standard group (52% vs 26%; P = .046). For outcomes, there were fewer wound complications in the NPWT as compared with the standard group (13% vs 39%; P = .037). The types of wound-related complications in the NPWT group included one wound dehiscence with a deep SSI, one superficial SSI, and one incision line necrosis. In the standard group, there were four wound dehiscences with deep SSI, three superficial SSIs, four incision line necroses, and one stump hematoma. The rates of perioperative mortality and amputation revision did not differ significantly between the NPWT and the standard groups (3% vs 4% and 4.3% vs 10%, respectively). CONCLUSIONS: Closed incision NPWT may decrease the incidence of wound complications in vascular patients undergoing major LEA. This held true even among a population that was potentially at higher risk. This therapy may be considered for use in lower extremity major amputations.

Negative pressure wound therapy for surgical wounds healing by primary closure.

BACKGROUND: Indications for the use of negative pressure wound therapy (NPWT) are broad and include prophylaxis for surgical site infections (SSIs). Existing evidence for the effectiveness of NPWT on postoperative wounds healing by primary closure remains uncertain. OBJECTIVES: To assess the effects of NPWT for preventing SSI in wounds healing through primary closure, and to assess the cost-effectiveness of NPWT in wounds healing through primary closure. SEARCH METHODS: In June 2019, we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries and references of included studies, systematic reviews and health technology reports. There were no restrictions on language, publication date or study setting. SELECTION CRITERIA: We included trials if they allocated participants to treatment randomly and compared NPWT with any other type of wound dressing, or compared one type of NPWT with another type of NPWT. DATA COLLECTION AND ANALYSIS: At least two review authors independently assessed trials using predetermined inclusion criteria. We carried out data extraction, assessment using the Cochrane 'Risk of bias' tool, and quality assessment according to Grading of Recommendations, Assessment, Development and Evaluations methodology. MAIN RESULTS: In this third update, we added 15 new randomised controlled trials (RCTs) and three new economic studies, resulting in a total of 44 RCTs (7447 included participants) and five economic studies. Studies evaluated NPWT in the context of a wide range of surgeries including orthopaedic, obstetric, vascular and general procedures. Economic studies assessed NPWT in orthopaedic, obstetric and general surgical settings. All studies compared NPWT with standard dressings. Most studies had unclear or high risk of bias for at least one key domain. Primary outcomes Four studies (2107 participants) reported mortality. There is low-certainty evidence (downgraded twice for imprecision) showing no clear difference in the risk of death after surgery for people treated with NPWT (2.3%) compared with standard dressings (2.7%) (risk ratio (RR) 0.86; 95% confidence interval (CI) 0.50 to 1.47; I2 = 0%). Thirty-nine studies reported SSI; 31 of these (6204 participants), were included in meta-analysis. There is moderate-certainty evidence (downgraded once for risk of bias) that NPWT probably results in fewer SSI (8.8% of participants) than treatment with standard dressings (13.0% of participants) after surgery; RR 0.66 (95% CI 0.55 to 0.80 ; I2 = 23%). Eighteen studies reported dehiscence; 14 of these (3809 participants) were included in meta-analysis. There is low-certainty evidence (downgraded once for risk of bias and once for imprecision) showing no clear difference in the risk of dehiscence after surgery for NPWT (5.3% of participants) compared with standard dressings (6.2% of participants) (RR 0.88, 95% CI 0.69 to 1.13; I2 = 0%). Secondary outcomes There is low-certainty evidence showing no clear difference between NPWT and standard treatment for the outcomes of reoperation and incidence of seroma. For reoperation, the RR was 1.04 (95% CI 0.78 to 1.41; I2 = 13%; 12 trials; 3523 participants); for seroma, the RR was 0.72 (95% CI 0.50 to 1.05; I2 = 0%; seven trials; 729 participants). The effect of NPWT on occurrence of haematoma or skin blisters is uncertain (very low-certainty evidence); for haematoma, the RR was 0.67 (95% CI 0.28 to 1.59; I2 = 0%; nine trials; 1202 participants) and for blisters the RR was 2.64 (95% CI 0.65 to 10.68; I2 = 69%; seven trials; 796 participants). The overall effect of NPWT on pain is uncertain (very low-certainty evidence from seven trials (2218 participants) which reported disparate measures of pain); but moderate-certainty evidence suggests there is probably little difference between the groups in pain after three or six months following surgery for lower limb fracture (one trial, 1549 participants). There is also moderate-certainty evidence for women undergoing caesarean sections (one trial, 876 participants) and people having surgery for lower limb fractures (one trial, 1549 participants) that there is probably little difference in quality of life scores at 30 days or 3 or 6 months, respectively. Cost-effectiveness Five economic studies, based wholly or partially on trials included in our review, assessed the cost-effectiveness of NPWT compared with standard care. They considered NPWT in four indications: caesarean sections in obese women; surgery for lower limb fracture; knee/hip arthroplasty and coronary artery bypass graft surgery. They calculated quality-adjusted life-years for treatment groups and produced estimates of the treatments' relative cost-effectiveness. The reporting quality was good but the grade of the evidence varied from moderate to very low. There is moderate-certainty evidence that NPWT in surgery for lower limb fracture was not cost-effective at any threshold of willingness-to-pay and that NPWT is probably cost-effective in obese women undergoing caesarean section. Other studies found low or very low-certainty evidence indicating that NPWT may be cost-effective for the indications assessed. AUTHORS' CONCLUSIONS: People experiencing primary wound closure of their surgical wound and treated prophylactically with NPWT following surgery probably experience fewer SSI than people treated with standard dressings (moderate-certainty evidence). There is no clear difference in number of deaths or wound dehiscence between people treated with NPWT and standard dressings (low-certainty evidence). There are also no clear differences in secondary outcomes where all evidence was low or very low-certainty. In caesarean section in obese women and surgery for lower limb fracture, there is probably little difference in quality of life scores (moderate-certainty evidence). Most evidence on pain is very low-certainty, but there is probably no difference in pain between NPWT and standard dressings after surgery for lower limb fracture (moderate-certainty evidence). Assessments of cost-effectiveness of NPWT produced differing results in different indications. There is a large number of ongoing studies, the results of which may change the findings of this review. Decisions about use of NPWT should take into account surgical indication and setting and consider evidence for all outcomes.

Negative pressure wound therapy for surgical wounds healing by primary closure.

BACKGROUND: Indications for the use of negative pressure wound therapy (NPWT) are broad and include prophylaxis for surgical site infections (SSIs). Existing evidence for the effectiveness of NPWT on postoperative wounds healing by primary closure remains uncertain. OBJECTIVES: To assess the effects of NPWT for preventing SSI in wounds healing through primary closure, and to assess the cost-effectiveness of NPWT in wounds healing through primary closure. SEARCH METHODS: In June 2019, we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries and references of included studies, systematic reviews and health technology reports. There were no restrictions on language, publication date or study setting. SELECTION CRITERIA: We included trials if they allocated participants to treatment randomly and compared NPWT with any other type of wound dressing, or compared one type of NPWT with another type of NPWT. DATA COLLECTION AND ANALYSIS: At least two review authors independently assessed trials using predetermined inclusion criteria. We carried out data extraction, assessment using the Cochrane 'Risk of bias' tool, and quality assessment according to Grading of Recommendations, Assessment, Development and Evaluations methodology. MAIN RESULTS: In this third update, we added 15 new randomised controlled trials (RCTs) and three new economic studies, resulting in a total of 44 RCTs (7447 included participants) and five economic studies. Studies evaluated NPWT in the context of a wide range of surgeries including orthopaedic, obstetric, vascular and general procedures. Economic studies assessed NPWT in orthopaedic, obstetric and general surgical settings. All studies compared NPWT with standard dressings. Most studies had unclear or high risk of bias for at least one key domain. Primary outcomes Four studies (2107 participants) reported mortality. There is low-certainty evidence (downgraded twice for imprecision) showing no clear difference in the risk of death after surgery for people treated with NPWT (2.3%) compared with standard dressings (2.7%) (risk ratio (RR) 0.86; 95% confidence interval (CI) 0.50 to 1.47; I2 = 0%). Thirty-nine studies reported SSI; 31 of these (6204 participants), were included in meta-analysis. There is moderate-certainty evidence (downgraded once for risk of bias) that NPWT probably results in fewer SSI (8.8% of participants) than treatment with standard dressings (13.0% of participants) after surgery; RR 0.66 (95% CI 0.55 to 0.80 ; I2 = 23%). Eighteen studies reported dehiscence; 14 of these (3809 participants) were included in meta-analysis. There is low-certainty evidence (downgraded once for risk of bias and once for imprecision) showing no clear difference in the risk of dehiscence after surgery for NPWT (5.3% of participants) compared with standard dressings (6.2% of participants) (RR 0.88, 95% CI 0.69 to 1.13; I2 = 0%). Secondary outcomes There is low-certainty evidence showing no clear difference between NPWT and standard treatment for the outcomes of reoperation and incidence of seroma. For reoperation, the RR was 1.04 (95% CI 0.78 to 1.41; I2 = 13%; 12 trials; 3523 participants); for seroma, the RR was 0.72 (95% CI 0.50 to 1.05; I2 = 0%; seven trials; 729 participants). The effect of NPWT on occurrence of haematoma or skin blisters is uncertain (very low-certainty evidence); for haematoma, the RR was 0.67 (95% CI 0.28 to 1.59; I2 = 0%; nine trials; 1202 participants) and for blisters the RR was 2.64 (95% CI 0.65 to 10.68; I2 = 69%; seven trials; 796 participants). The overall effect of NPWT on pain is uncertain (very low-certainty evidence from seven trials (2218 participants) which reported disparate measures of pain); but moderate-certainty evidence suggests there is probably little difference between the groups in pain after three or six months following surgery for lower limb fracture (one trial, 1549 participants). There is also moderate-certainty evidence for women undergoing caesarean sections (one trial, 876 participants) and people having surgery for lower limb fractures (one trial, 1549 participants) that there is probably little difference in quality of life scores at 30 days or 3 or 6 months, respectively. Cost-effectiveness Five economic studies, based wholly or partially on trials included in our review, assessed the cost-effectiveness of NPWT compared with standard care. They considered NPWT in four indications: caesarean sections in obese women; surgery for lower limb fracture; knee/hip arthroplasty and coronary artery bypass graft surgery. They calculated quality-adjusted life-years for treatment groups and produced estimates of the treatments' relative cost-effectiveness. The reporting quality was good but the grade of the evidence varied from moderate to very low. There is moderate-certainty evidence that NPWT in surgery for lower limb fracture was not cost-effective at any threshold of willingness-to-pay and that NPWT is probably cost-effective in obese women undergoing caesarean section. Other studies found low or very low-certainty evidence indicating that NPWT may be cost-effective for the indications assessed. AUTHORS' CONCLUSIONS: People experiencing primary wound closure of their surgical wound and treated prophylactically with NPWT following surgery probably experience fewer SSI than people treated with standard dressings (moderate-certainty evidence). There is no clear difference in number of deaths or wound dehiscence between people treated with NPWT and standard dressings (low-certainty evidence). There are also no clear differences in secondary outcomes where all evidence was low or very low-certainty. In caesarean section in obese women and surgery for lower limb fracture, there is probably little difference in quality of life scores (moderate-certainty evidence). Most evidence on pain is very low-certainty, but there is probably no difference in pain between NPWT and standard dressings after surgery for lower limb fracture (moderate-certainty evidence). Assessments of cost-effectiveness of NPWT produced differing results in different indications. There is a large number of ongoing studies, the results of which may change the findings of this review. Decisions about use of NPWT should take into account surgical indication and setting and consider evidence for all outcomes.

Treatment of Lymphatic Complications after Common Femoral Artery Endarterectomy.

BACKGROUND: This study analyzes the outcome of lymphatic complications after a standard vascular procedure. METHODS: This is a retrospective study including patients who had a lymphatic complication after endarterectomy and patch of the common femoral artery in our clinic between March 2007 and June 2018. Therapy of choice was selected according to wound situation and amount of lymphatic liquid. If signs of a wound infection occurred, a surgical therapy was performed; in all other cases a nonsurgical treatment (conservative treatment, radiotherapy) was chosen. RESULTS: We performed 977 index operations, a lymphatic complication occurred in 112 cases (11.5%). In 69 cases the lymphatic complication presented as lymphatic fistula (Group 1), in 43 cases as lymphorrhea from the wound (Group 2). Nonsurgical treatment was done in 66 cases (Group 1: 76.8% vs. Group 2: 30.2%; P < 0.000), and a surgical treatment was necessary in 46 cases (Group 1: 23.2% vs. Group 2: 69.8%; P < 0.000). Indication for surgery was Szilagyi 1 infection in 25 cases, Szilagyi 2 infection in 11 cases, and Szilagyi 3 infection in 10 cases. Patients with Szilagyi 1 infections received negative wound pressure therapy (NWPT). A muscle flap in combination with an NWPT was performed in patients with Szilagyi 2 infections. In Szilagyi 3 infections, the patch was replaced; additionally, a muscle flap and an NWPT were performed. The median hospital stay was 13 days in the nonsurgical group and 22.5 days in the surgical group. We had no bleeding complications and no reinfection during follow-up. The median observation period was 23.0 months. Age ≥80 years was associated with an increased risk for lymphatic complications. CONCLUSIONS: The therapy of lymphatic complications should be done in accordance with clinical symptoms. A nonsurgical treatment is often sufficient. However, in cases of a wound infection different surgical treatments are necessary.

Sternoclavicular Joint Infections: Improved Outcomes With Myocutaneous Flaps.

Sternoclavicular joint (SCJ) infection is a rare disease and its management remains controversial. Our institution has adopted an aggressive surgical approach of radical SCJ resection combined with myocutaneous flap (MCF) closure whenever possible. We reviewed our experience with this approach in the management of this condition. From July 2004 to June 2018, 50 consecutive patients were treated surgically for SCJ infections. Patient demographics, imaging studies, microbiology, and operative variables were analyzed. All patients underwent ipsilateral SCJ resection. Wound closure was performed with primary pectoralis advancement MCF closure at the initial operation in 25 patients, delayed MCF closure following temporary wound vacuum therapy and redebridement in 19 patients, and definitive wound vacuum therapy (DWVT) in 6 patients. End points were recurrence of infection, perioperative morbidity, and mortality. Localized swelling (100%) and pain (100%) were the most common presenting symptoms. MSSA was isolated in 50% of tissue cultures. Comorbidities included tobacco smoking 52%, diabetes mellitus 50%, intravenous drug use 34%, poor dental hygiene 32%, and obesity 28%. We had no deaths within 90 days of operation. Complications; seroma in 1 patient (2%), chest wall hernia in 1 patient (2%), retained drains in 1 patient (2%), recurrent osteomyelitis infection in 3 patients (6%), and hematomas in 5 patients (10%). Patients treated with primary MCF closure at the initial operation had a 0% (0/25) rate of recurrence compared to 5.26% (1/19) in delayed MCF closure. Overall, there was only a 2.27% (1/44) recurrence of infection in primary and delayed MCF closure combined, compared to 33.33% (2/6) in patients treated with DWVT closure. SCJ infections require an aggressive approach. Wound closure with an MCF (primary or delayed) is associated with less recurrence of infections compared with DWVT closure. Radical resection of the entire SCJ with MCF (primary or delayed) should be considered the preferred management strategy in patients with SCJ infections.

Negative pressure wound therapy for surgical wounds healing by primary closure.

BACKGROUND: Indications for the use of negative pressure wound therapy (NPWT) are broad and include prophylaxis for surgical site infections (SSIs). While existing evidence for the effectiveness of NPWT remains uncertain, new trials necessitated an updated review of the evidence for the effects of NPWT on postoperative wounds healing by primary closure. OBJECTIVES: To assess the effects of negative pressure wound therapy for preventing surgical site infection in wounds healing through primary closure. SEARCH METHODS: We searched the Cochrane Wounds Specialised Register, CENTRAL, Ovid MEDLINE (including In-Process & Other Non-Indexed Citations), Ovid Embase, and EBSCO CINAHL Plus in February 2018. We also searched clinical trials registries for ongoing and unpublished studies, and checked reference lists of relevant included studies as well as reviews, meta-analyses, and health technology reports to identify additional studies. There were no restrictions on language, publication date, or setting. SELECTION CRITERIA: We included trials if they allocated participants to treatment randomly and compared NPWT with any other type of wound dressing, or compared one type of NPWT with another type of NPWT. DATA COLLECTION AND ANALYSIS: Four review authors independently assessed trials using predetermined inclusion criteria. We carried out data extraction, 'Risk of bias' assessment using the Cochrane 'Risk of bias' tool, and quality assessment according to GRADE methodology. MAIN RESULTS: In this second update we added 25 intervention trials, resulting in a total of 30 intervention trials (2957 participants), and two economic studies nested in trials. Surgeries included abdominal and colorectal (n = 5); caesarean section (n = 5); knee or hip arthroplasties (n = 5); groin surgery (n = 5); fractures (n = 5); laparotomy (n = 1); vascular surgery (n = 1); sternotomy (n = 1); breast reduction mammoplasty (n = 1); and mixed (n = 1). In three key domains four studies were at low risk of bias; six studies were at high risk of bias; and 20 studies were at unclear risk of bias. We judged the evidence to be of low or very low certainty for all outcomes, downgrading the level of the evidence on the basis of risk of bias and imprecision.Primary outcomesThree studies reported mortality (416 participants; follow-up 30 to 90 days or unspecified). It is uncertain whether NPWT has an impact on risk of death compared with standard dressings (risk ratio (RR) 0.63, 95% confidence interval (CI) 0.25 to 1.56; very low-certainty evidence, downgraded once for serious risk of bias and twice for very serious imprecision).Twenty-five studies reported on SSI. The evidence from 23 studies (2533 participants; 2547 wounds; follow-up 30 days to 12 months or unspecified) showed that NPWT may reduce the rate of SSIs (RR 0.67, 95% CI 0.53 to 0.85; low-certainty evidence, downgraded twice for very serious risk of bias).Fourteen studies reported dehiscence. We combined results from 12 studies (1507 wounds; 1475 participants; follow-up 30 days to an average of 113 days or unspecified) that compared NPWT with standard dressings. It is uncertain whether NPWT reduces the risk of wound dehiscence compared with standard dressings (RR 0.80, 95% CI 0.55 to 1.18; very low-certainty evidence, downgraded twice for very serious risk of bias and once for serious imprecision).Secondary outcomesWe are uncertain whether NPWT increases or decreases reoperation rates when compared with a standard dressing (RR 1.09, 95% CI 0.73 to 1.63; 6 trials; 1021 participants; very low-certainty evidence, downgraded for very serious risk of bias and serious imprecision) or if there is any clinical benefit associated with NPWT for reducing wound-related readmission to hospital within 30 days (RR 0.86, 95% CI 0.47 to 1.57; 7 studies; 1271 participants; very low-certainty evidence, downgraded for very serious risk of bias and serious imprecision). It is also uncertain whether NPWT reduces incidence of seroma compared with standard dressings (RR 0.67, 95% CI 0.45 to 1.00; 6 studies; 568 participants; very low-certainty evidence, downgraded twice for very serious risk of bias and once for serious imprecision). It is uncertain if NPWT reduces or increases the risk of haematoma when compared with a standard dressing (RR 1.05, 95% CI 0.32 to 3.42; 6 trials; 831 participants; very low-certainty evidence, downgraded twice for very serious risk of bias and twice for very serious imprecision. It is uncertain if there is a higher risk of developing blisters when NPWT is compared with a standard dressing (RR 6.64, 95% CI 3.16 to 13.95; 6 studies; 597 participants; very low-certainty evidence, downgraded twice for very serious risk of bias and twice for very serious imprecision).Quality of life was not reported separately by group but was used in two economic evaluations to calculate quality-adjusted life years (QALYs). There was no clear difference in incremental QALYs for NPWT relative to standard dressing when results from the two trials were combined (mean difference 0.00, 95% CI -0.00 to 0.00; moderate-certainty evidence).One trial concluded that NPWT may be more cost-effective than standard care, estimating an incremental cost-effectiveness ratio (ICER) value of GBP 20.65 per QALY gained. A second cost-effectiveness study estimated that when compared with standard dressings NPWT was cost saving and improved QALYs. We rated the overall quality of the reports as very good; we did not grade the evidence beyond this as it was based on modelling assumptions. AUTHORS' CONCLUSIONS: Despite the addition of 25 trials, results are consistent with our earlier review, with the evidence judged to be of low or very low certainty for all outcomes. Consequently, uncertainty remains about whether NPWT compared with a standard dressing reduces or increases the incidence of important outcomes such as mortality, dehiscence, seroma, or if it increases costs. Given the cost and widespread use of NPWT for SSI prophylaxis, there is an urgent need for larger, well-designed and well-conducted trials to evaluate the effects of newer NPWT products designed for use on clean, closed surgical incisions. Such trials should initially focus on wounds that may be difficult to heal, such as sternal wounds or incisions on obese patients.

Advances in managing the noninfected open chest after cardiac surgery: Negative-pressure wound therapy.

OBJECTIVE: The objective of this study was to compare safety and clinical effectiveness of negative-pressure wound therapy (NPWT) with traditional wound therapy for managing noninfected open chests with delayed sternal closure after cardiac surgery. METHODS: From January 2000 to July 2015, 452 of 47,325 patients who underwent full sternotomy left the operating room with a noninfected open chest (0.96%), managed using NPWT in 214-with frequency of use rapidly increasing to near 100%-and traditionally in 238. Predominant indications for open-chest management were uncontrolled coagulopathy or hemodynamic compromise on attempted chest closure. Weighted propensity-score matching was used to assess in-hospital complications and time-related survival. RESULTS: NPWT and traditionally managed patients had similar high-risk preoperative profiles. Most underwent reoperations (63% of the NPWT group and 57% of the traditional group), and 21% versus 25% were emergency procedures. Reexplorations for bleeding were less common with NPWT versus traditional wound therapy (n = 63 [29%] vs 104 [44%], P = .002). Median duration of open-chest to definitive sternal closure was 3.5 days for NPWT versus 3.1 for traditionally managed patients (P[log rank] = .07). Seven patients (3.3%) were converted from NPWT to traditional therapy because of hemodynamic intolerance and 6 (2.5%) from traditional to NPWT. No NPWT-related cardiovascular injuries occurred. Among matched patients, NPWT was associated with better early survival (61% vs 44% at 6 months; P = .02). CONCLUSIONS: NPWT is safe and effective for managing noninfected open chests after cardiac surgery. By facilitating open-chest management and potentially improving outcomes, it has become our therapy of choice and perhaps has lowered our threshold for leaving the chest open after cardiac surgery.

The fate of patients having deep sternal infection after bilateral internal thoracic artery grafting in the negative pressure wound therapy era.

BACKGROUND: Late survival of patients having deep sternal wound infection (DSWI) after bilateral internal thoracic artery (BITA) grafting is largely unexplored. METHODS: Outcomes of 3391 consecutive BITA patients were reviewed retrospectively. Patients with DSWI after surgery (n = 142, 4.2%) were compared with those having no sternal complications (n = 3177). Predictors of DSWI and of mortality during the follow-up period were found with negative-binomial and Cox proportional-hazards regression, respectively. One-to-one propensity score-matched analysis, which considered simultaneously baseline patient characteristics, operative data, and postoperative complications was performed. The resulting matched pairs were compared for non-parametric estimates of late survival. The same comparison was performed in matched pairs having no major complications (except DSWI) early after surgery. RESULTS: In-hospital mortality was higher in DSWI cohort than in patients having no sternal complications (5.6% vs. 1.8%, p = 0.0035). Almost all of postoperative complications were more frequent in DSWI patients. Female sex, obesity, chronic lung disease, renal impairment, extracardiac arteriopathy, congestive heart failure, and urgent/emergency priority were predictors of DSWI common to two DSWI risk models that were developed. DSWI was independent predictor of reduced late survival (multiple covariates-adjusted hazard ratio [HR], 1.91, p < 0.0001). The propensity matching resulted in 135 pairs with same in-hospital mortality (5.2%). Estimates of freedom from all-cause death were lower in DSWI cohort (HR, 1.92, p < 0.0001), even when only pairs (n = 59) having no major postoperative complications (except DSWI) were considered (HR, 1.84, p = 0.026). CONCLUSIONS: DSWI after BITA use seems to reduce late survival even after adjusting for baseline patient characteristics and concomitant postoperative complications.

Primary and Rescue Endoluminal Vacuum Therapy in the Management of Esophageal Perforations and Leaks.

BACKGROUND: To investigate the efficacy of primary and rescue endoluminal vacuum (EVAC) therapy in the treatment of esophageal perforations and leaks. METHODS: We conducted a retrospective review of a prospectively gathered, Institutional Review Board (IRB) approved database of EVAC therapy patients at our center from July 2013 to September 2016. RESULTS: In all, 13 patients were treated for esophageal perforations or leaks. Etiologies included iatrogenic injury (n = 8), anastomotic leak (n = 2), Boerhaave syndrome (n = 1), and bronchoesophageal fistula (n = 2). In total, 10 patients underwent primary treatment and three were treated with rescue therapy. Mean Perforation Severity Scores (PSSs) in the primary and rescue treatment groups were 7 and 10, respectively. Average defect size was 2.4 (range: 0.5-6) cm. The rescue group had a shorter mean time to defect closure (25 vs. 33 days). In all, 12 of 13 defects healed. One death occurred following the implementation of comfort care. One therapy-specific complication occurred. Hospital length of stay (LOS) was longer in the rescue group (72 vs. 53 days); however, the intensive care unit (ICU) duration was similar between groups. Totally, 10 patients (83%) resumed an oral diet after successful defect closure. CONCLUSION: Utilized as either a primary or rescue therapy, EVAC therapy appears to be beneficial in the management of esophageal perforations or leaks.

Outcome and Complications Using Negative Pressure Wound Therapy in the Groin for Perivascular Surgical Site Infections after Vascular Surgery.

BACKGROUND: The aim of this study was to investigate graft preservation, major bleeding, and reinfection rate using negative pressure wound therapy (NPWT) for perivascular surgical site infections (SSIs) in the groin after vascular surgery and factors associated with failure of treatment. METHODS: Retrospective data were collected during 2004-2015. Failure of wound treatment was defined as a wound not healed within 4 months, visible graft material or native artery after 1 month, bleeding from the wound leading to discontinuation of treatment, or death or amputation due to the groin infection. RESULTS: The median age of the 161 patients was 71 years; 63% were men. The rate of graft preservation rate was 81%; 64% for synthetic grafts. Major bleeding during NPWT occurred in 7.1% and local reinfection in 6.4%. Synthetic graft infection (odds ratio [OR] = 6.1, 95% confidence interval [CI] = 2.6-14.4) and bleeding/pseudoaneurysm as presenting symptom (OR = 2.9, 95% CI = 1.0-8.2) were independently associated with increased failure rate of treatment. CONCLUSIONS: NPWT is a good option for perivascular SSI in the groin after vascular surgery. Patients with a synthetic graft infection and/or presenting with pseudoaneurysm or bleeding may be considered for an adjunctive or alternative treatment option.

Randomized clinical trial of negative pressure wound therapy for high-risk groin wounds in lower extremity revascularization.

OBJECTIVE: The surgical site infection (SSI) rate in vascular surgery after groin incision for lower extremity revascularization can lead to significant morbidity and mortality. This trial was designed to study the effect of negative pressure wound therapy (NPWT) on SSI in closed groin wounds after lower extremity revascularization in patients at high risk for SSI. METHODS: A single-center, randomized, controlled trial was performed at an academic tertiary medical center. Patients with previous femoral artery surgical exposure, body mass index of >30 kg/m2 or the presence of ischemic tissue loss were classified as a high-risk patient for SSI. All wounds were closed primarily and patients were randomized to either NPWT or standard dressing. The primary outcome of the trial was postoperative 30-day SSI in the groin wound. The secondary outcomes included 90-day SSI, hospital duration of stay, readmissions or reoperations for SSI, and mortality. RESULTS: A total of 102 patients were randomized between August 2014 and December 2015. Patients were classified as at high risk owing to the presence of previous femoral artery cut down (29%), body mass index of >30 kg/m2 (39%) or presence of ischemic tissue loss (32%). Revascularization procedures performed included femoral to distal artery bypass (57%), femoral endarterectomy (18%), femoral to femoral artery crossover (17%), and other procedures (8%). The primary outcome of 30-day SSI was 11% in NPWT group versus 19% in standard dressing group (P = .24). There was a statistically significant shorter mean duration of hospital stay in the NPWT group (6.4 days) compared with the standard group (8.9 days; P = .01). There was no difference in readmission or reoperation for SSI or mortality between the two groups. CONCLUSIONS: This study demonstrated a nonsignificant lower rate of groin SSI in high-risk revascularization patients with NPWT compared with standard dressing. Owing to a lower than expected infection rate, the study was underpowered to detect a difference at the prespecified level. The NPWT group did show significantly shorter mean hospital duration of stay compared with the standard dressing group.

Open abdomen with vacuum-assisted wound closure and mesh-mediated fascial traction in patients with complicated diffuse secondary peritonitis: A single-center 8-year experience.

BACKGROUND: Open abdomen (OA) treatment in patients with peritonitis is increasing worldwide. Various temporary abdominal closure devices are being used. This study included patients with complicated diffuse secondary peritonitis, OA, and vacuum-assisted wound closure and mesh-mediated fascial traction (VAWCM). The aim of this study was to describe mortality and major morbidity in terms of delayed primary fascial closure and enteroatmospheric fistula rates. METHODS: This was a single-academic-center retrospective study of consecutive patients with diffuse peritonitis, OA, and VAWCM between years 2008 and 2016. Descriptive and univariate analyses were performed. RESULTS: Forty-one patients were identified and analyzed. Median age was 59 years, preoperative septic shock was diagnosed in 54% (n = 22), and 59% (n = 24) had a postoperative peritonitis. Mortality was 29% (n = 12), and 76% (n = 31) of patients were admitted in the intensive care unit. The median duration of OA was 7 days with a median of two dressing changes. Delayed primary fascial closure rate among survivors was 92% (n = 33), and enteroatmospheric fistulas developed in 7% (n = 3). In a subgroup analysis, patients with OA in the primary laparotomy for peritonitis (n = 27) were compared with patients with OA in the subsequent laparotomies (n = 14). There were no significant differences between groups. CONCLUSIONS: The VAWCM technique in patients with complicated secondary diffuse peritonitis and OA yields excellent results in terms of delayed primary fascial closure rate and a low number of enteroatmospheric fistulas. It seems to be safe to close the abdomen at the index laparotomy, if possible, even if there is a risk of a need of OA later. LEVEL OF EVIDENCE: Therapeutic/care management study, level IV.

Complications and Mortality Associated with Temporary Abdominal Closure Techniques: A Systematic Review and Meta-Analysis.

Temporary abdominal closure (TAC) techniques are routinely used in the open abdomen. Ideally, they should prevent evisceration, aid in removal of unwanted fluid from the peritoneal cavity, facilitate in achieving safe definitive fascial closure, as well as prevent the development of intra-abdominal complications. TAC techniques used in the open abdomen were compared with negative pressure wound therapy (NPWT) to identify which was superior. A systematic review was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines involving Medline, Excerpta Medica, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, and Clinicaltrials.gov. All studies describing TAC technique use in the open abdomen were eligible for inclusion. Data were analyzed per TAC technique in the form of a meta-analysis. A total of 225 articles were included in the final analysis. A meta-analysis involving only randomized controlled trials showed that NPWT with continuous fascial closure was superior to NPWT alone for definitive fascial closure [mean difference (MD): 35% ± 23%; P = 0.0044]. A subsequent meta-analysis involving all included studies confirmed its superiority across outcomes for definitive fascial closure (MD: 19% ± 3%; P < 0.0001), perioperative (MD: -4.0% ± 2.4%; P = 0.0013) and in-hospital (MD: -5.0% ± 2.9%; P = 0.0013) mortality, entero-atmospheric fistula (MD: -2.0% ± 1.8%; P = 0.0041), ventral hernia (MD: -4.0% ± 2.4%; P = 0.0010), and intra-abdominal abscess (MD: -3.1% ± 2.1%; P = 0.0044). Therefore, it was concluded that NPWT with continuous fascial traction is superior to NPWT alone.

Open Abdomen Treated with Negative Pressure Wound Therapy: Indications, Management and Survival.

BACKGROUND: Open abdomen treatment (OAT) is a significant burden for patients and is associated with considerable mortality. The primary aim of this study was to report survival and cause of mortality after OAT. Secondary aims were to evaluate length of stay (LOS) in intensive care unit (ICU) and in hospital, time to abdominal closure and major complications. METHODS: Retrospective review of prospectively registered patients undergoing OAT between October 2006 and June 2014 at Trondheim University Hospital, Norway. RESULTS: The 118 patients with OAT had a median age of 63 (20-88) years. OAT indications were abdominal compartment syndrome (ACS) (n = 53), prophylactic (n = 29), abdominal contamination/second look laparotomy (n = 22), necrotizing fasciitis (n = 7), hemorrhage packing (n = 4) and full-thickness wound dehiscence (n = 3). Eight percent were trauma patients. Vacuum-assisted wound closure (VAWC) with mesh-mediated traction (VAWCM) was used in 92 (78 %) patients, the remaining 26 (22 %) had VAWC only. Per-protocol primary fascial closure rate was 84 %. Median time to abdominal closure was 12 days (1-143). LOS in the ICU was 15 (1-89), and in hospital 29 (1-246) days. Eighty-one (68 %) patients survived the hospital stay. Renal failure requiring renal replacement therapy (RRT) (OR 3.9, 95 % CI 1.37-11.11), ACS (OR 3.1, 95 % CI 1.19-8.29) and advanced age (OR 1.045, 95 % CI 1.004-1.088) were independent predictors of mortality in multivariate analysis. The nine patients with an entero-atmospheric fistula (EAF) survived. CONCLUSION: Two-thirds of the patients treated with OAT survived. Renal failure with RRT, ACS and advanced age were predictors of mortality, whereas EAF was not associated with increased mortality.

Bedside dressing changes for open abdomen in the intensive care unit is safe and time and staff efficient.

BACKGROUND: Patients with an open abdomen (OA) treated with temporary abdominal closure (TAC) need multiple surgical procedures throughout the hospital stay with repeated changes of the vacuum-assisted closure device (VAC changes). The aim of this study was to examine if using the intensive care unit (ICU) for dressing changes in OA patients was safe regarding bloodstream infections (BSI) and survival. Secondary aims were to evaluate saved time, personnel, and costs. METHODS: All patients treated with OA in the ICU from October 2006 to June 2014 were included. Data were retrospectively obtained from registered procedure codes, clinical and administrative patients' records and the OR, ICU, anesthesia and microbiology databases. Outcomes were 30-, 60- and 90-day survival, BSI, time used and saved personnel costs. RESULTS: A total of 113 patients underwent 960 surgical procedures including 443 VAC changes as a single procedure, of which 165 (37 %) were performed in the ICU. Nine patients died before the first scheduled dressing change and six patients were closed at the first scheduled surgery after established OA, leaving 98 patients for further analysis. The mean duration for the surgical team performing a VAC change in the ICU was 63.4 (60.4-66.4) minutes and in the OR 98.2 (94.6-101.8) minutes (p < 0.001). The mean duration for the anesthesia team in the OR was 115.5 minutes, while this team was not used in the ICU. Personnel costs were reduced by €682 per procedure when using the ICU. Forty-two patients had all the VAC changes done in the OR (VAC-OR), 22 in the ICU (VAC-ICU) and 34 in both OR and ICU (VAC-OR/ICU). BSI was diagnosed in eight (19 %) of the VAC-OR patients, seven (32 %) of the VAC-ICU and eight (24 %) of the VAC-OR/ICU (p = 0.509). Thirty-five patients (83 %) survived 30 days in the VAC-OR group, 17 in the VAC-ICU group (77 %) and 28 (82 %) in the VAC-OR/ICU group (p = 0.844). CONCLUSIONS: VAC change for OA in the ICU saved time for the OR team and the anesthesia team compared to using the OR, and it reduced personnel costs. Importantly, the use of ICU for OA dressing change seemed to be as safe as using the OR.

Systematic and Specific Treatment of Patients with Enteroatmospheric Fistulas: From Initial Conservative Treatment to Definitive Surgery.

INTRODUCTION: The open abdomen is a widespread therapeutic resource; however, it is also a source of complications, of which the enteroatmospheric fistulas (EAFs) pose one of the greatest problems. The objective of this study was to describe the implemented strategy for handling enteroatmospheric fistulas, and secondarily, to analyze the differential results based on a change in the conservative local treatment specifically designed for the stated complication. MATERIALS AND METHODS: From March 2002 to March 2014, patients treated for EAF were retrospectively analyzed. They were divided into 2 groups: Group 1 (G1: 2002 - 2007), treated with an occlusive vacuum device (SIVACO), similar to that used for other enterocutaneous fistulas, and Group 2 (G2: 2008 - 2014), covered in a specific modality for EAF. Results of conservative and surgical treatment were described and then the two groups were statistically compared. RESULTS: Study participants comprised 62 patients. Twelve cases (19.4%) healed with conservative treatment. This was statistically related with a baseline albumin level >3 g/dL, single lesions with no visible mucosa and baseline output <700 mL/d. In G1, the output fall was higher, while G2 required fewer wound dressing changes and enteral nutrition was feasible in a significantly higher number of patients. Forty-seven patients underwent reconstructive surgery. The mortality-associated variables were preoperative hypoalbuminemia and 2 or more anastomoses. Overall mortality was 8% (5 patients). In the multivariate model, only initial output (<700 mL/d) was an independent predictor for spontaneous closure, whereas 2 or more anastomoses and hypoalbuminemia were negative independent predictors. CONCLUSION: Systematic management of enteroatmospheric fistulas, following a rigorous protocol and a two-step specific treatment, resulted in a practical approach and yielded good results in healing and mortality.

Negative pressure wound therapy for high-risk wounds in lower extremity revascularization: study protocol for a randomized controlled trial.

BACKGROUND: Rates of surgical site infections (SSIs) following groin incision for femoral artery exposure are much higher than expected of a clean operation. The morbidity and mortality is high, particularly with the use of prosthetic grafts. The vascular surgery population is at an increased risk of SSIs related to peripheral vascular disease (PVD), diabetes, obesity, previous surgery and presence of tissue loss. Negative pressure wound therapy (NPWT) dressings have been used on primarily closed incisions to reduce surgical site infections in other surgical disciplines. We have not come across any randomized controlled trials to support the prophylactic use of negative pressure wound therapy in high-risk vascular patients undergoing lower limb revascularization. METHODS/DESIGN: In this single-center, prospective randomized controlled trial, patients scheduled for a lower limb revascularization requiring open femoral artery exposure who are at a high risk (BMI > 30 kg/m(2), previous femoral cutdown or Rutherford V or VI category for chronic limb ischemia) will be eligible for the study. A total of 108 groin incisions will be randomized to the use of a negative pressure wound device or standard adhesive gauze dressing. Patients will be followed in hospital and reassessed within the first 30 days postoperatively. The primary outcome is SSI within the first 30 days of surgery and will be determined using the intention-to-treat principle. Secondary outcomes include length of stay, emergency room visits, reoperation, amputation and mortality. A cost analysis will be performed. DISCUSSION: The trial is expected to define the role of NPWT in SSI prophylaxis for lower limb revascularization in high-risk vascular patients. The results of the study will be used to inform current best practice for perioperative care and the minimization of SSIs. TRIAL REGISTRATION: NCT02084017 , March 2014.

The Use of Vacuum-Assisted Closure in Purulent Complications and Difficult-To-Heal Wounds in Cardiac Surgery.

BACKGROUND: Sternal wound infections are a serious and potentially fatal complication of cardiac surgery. OBJECTIVES: The aim of the study was to analyze the results of using the vacuum-assisted closure (VAC) system over a 4-year period. MATERIAL AND METHODS: Quantitative VAC performance data from a retrospective review of a consecutive cohort of 47 patients treated with VAC for post-cardiac surgery wound complications were collected and statistically analyzed. In the study group 35 patients developed infections of the post-operative chest wound. In 12 other patients wound dehiscence was observed, but repeated cultures did not reveal the presence of any bacteria. RESULTS: The statistical analysis identified the following as significant risk factors: age, female sex, being overweight, a high total logistic EuroScore, the use of both internal thoracic arteries for bypass grafting, and diabetes. In the wound negative culture group the total length of hospital stay was significantly shorter than in the wound positive culture group. Mortality in this group was 0.0% vs. 5.7% in the wound positive culture group. In the study material, Gram-negative bacteria were responsible for 77% of the post-operative wound infections, with only 14% Gram-positive wound cultures. No complications were related to VAC use. CONCLUSIONS: The use of negative-pressure wound therapy with other concomitant surgical procedures is a good method of treating infected wounds as well as non-contaminated dehiscence of the wound and sternum. Considering that most of the infections within the authors' department are caused by Gram-negative bacteria, it would be beneficial to consider modifying the model of preventive antibiotic treatment to cover the Gram-negative spectrum in addition to the Gram-positive bacteria currently targeted.

Vacuum-assisted closure device for the management of infected postpneumonectomy chest cavities.

BACKGROUND: Infected postpneumonectomy chest cavities may be related to chronic postpneumonectomy empyema or arise in rare situations of necrotizing pneumonia with complete lung destruction where pneumonectomy and pleural debridement are required. We evaluated the safety and efficacy of an intrathoracic vacuum-assisted closure device (VAC) for the treatment of infected postpneumonectomy chest cavities. METHOD: A retrospective single institution review of all patients with infected postpneumonectomy chest cavities treated by VAC between 2005 and 2013. Patients underwent surgical debridement of the thoracic cavity, muscle flap closure of the bronchial stump when a fistula was present, and repeated intrathoracic VAC dressings until granulation tissue covered the entire chest cavity. After this, the cavity was obliterated by a Clagett procedure and closed. RESULTS: Twenty-one patients (14 men and 7 women) underwent VAC treatment of their infected postpneumonectomy chest cavity. Twelve patients presented with a chronic postpneumonectomy empyema (10 of them with a bronchopleural fistula) and 9 patients with an empyema occurring in the context of necrotizing pneumonia treated by pneumonectomy. In-hospital mortality was 23%. The median duration of VAC therapy was 23 days (range, 4-61 days) and the median number of VAC changes per patient was 6 (range, 2-14 days). Infection control and successful chest cavity closure was achieved in all surviving patients. One adverse VAC treatment-related event was identified (5%). CONCLUSIONS: The intrathoracic VAC application is a safe and efficient treatment of infected postpneumonectomy chest cavities and allows the preservation of chest wall integrity.

Deep sternal wound infection after coronary artery bypass surgery: management and risk factor analysis for mortality.

BACKGROUND: Deep sternal wound infection is a life-threatening complication after cardiac surgery. The aim of this study was to investigate the factors leading to mortality, and to explore wound management techniques on deep sternal wound infection after coronary artery bypass surgery. METHODS: Between 2008 and 2013, 58 patients with deep sternal wound infection were analyzed. Risk factors for mortality and morbidity including age, gender, body mass index, smoking status, chronic renal failure, hypertension, diabetes, and treatment choice were investigated. RESULTS: In this study, 19 patients (32.7%) were treated by primary surgical closure (PSC), and 39 patients (67.3%) were treated by delayed surgical closure following a vacuum-assisted closure system (VAC). Preoperative patient characteristics were similar between the groups. Fourteen patients (24.1%) died in the postoperative first month. The mortality rate and mean duration of hospitalization in the PSC group was higher than in the VAC group (P = .026, P = .034). Significant risk factors for mortality were additional operation, diabetes mellitus, and a high level of EuroSCORE. CONCLUSIONS: Delayed surgical closure following VAC therapy may be associated with shorter hospitalization and lower mortality in patients with deep sternal wound infection. Additional operation, diabetes mellitus, and a high level of EuroSCORE were associated with mortality.