Incisional Negative Pressure Wound Therapy Research Articles

Meta-Analysis and Trial Sequential Analysis on Incisional Negative-Pressure Wound Therapy for Surgical Site Infection Prevention.

Meta-Analysis and Trial Sequential Analysis on Incisional Negative-Pressure Wound Therapy for Surgical Site Infection Prevention.

D147. Cost Effectiveness of Incisional Negative Pressure Wound Therapy in Penile Inversion Vaginoplasty

D147. Cost Effectiveness of Incisional Negative Pressure Wound Therapy in Penile Inversion Vaginoplasty

The Utility of Prevena Negative Pressure Wound Therapy on Groin Incisions for Critical Limb-Threatening Ischemia: A Single Institution Experience.

Incisional negative pressure wound therapy (iNPWT) is an adjunctive treatment that uses constant negative pressure suction to facilitate healing. The utility of this treatment modality on vascular operations for critical limb-threatening ischemia (CLTI) has yet to be elucidated. This study compares the incidence of postoperative wound complications between the Prevena Incision Management System, a type of iNPWT, and standard wound dressings for vascular patients who also underwent plastic surgery closure of groin incisions for CLTI. We performed a retrospective cohort study of 40 patients with CLTI who underwent 53 open vascular surgeries with subsequent sartorius muscle flap closure. Patient demographics, intraoperative details, and wound complications were measured from 2015 to 2018 at the University of California San Francisco. Two cohorts were generated based on the modality of postoperative wound management and compared on wound healing outcomes. Of the 53 groin incisions, 29 were managed with standard dressings, and 24 received iNPWT. Patient demographics, comorbidities, and operative characteristics were similar between the 2 groups. Patients who received iNPWT had a significantly lower rate of infection (8.33% vs 31.0%, P = 0.04) and dehiscence (0% vs 41.3%, P < 0.01). Furthermore, the iNPWT group had a significantly lower rate of reoperation (0% vs 17.2%, P = 0.03) for wound complications within 30 days compared with the control group and a moderately reduced rate of readmission (4.17% vs 20.7%, P = 0.08). Rates of infection, reoperation, and dehiscence were significantly reduced in patients whose groin incisions were managed with iNPWT compared with standard wound care. Readmission rates were also decreased, but this difference was not statistically significant. Our results suggest that implementing iNPWT for the management of groin incisions, particularly in patients undergoing vascular operations for CLTI, may significantly improve clinical outcomes.

The Prevena Restor Bella.FormTM in the management of lower limb traumatic wounds

Objectives: The Prevena Restor Bella.FormTM is a novel closed incisional negative pressure wound therapy with a 14 day lifespan and a large contact area. This study aims to demonstrate the utility of the Prevena Restor Bella.FormTM in high risk lower limb traumatic wounds. Methods: 4 consecutive patients with complex traumatic lower limb wounds were included. The Prevena Restor Bella.FormTM was applied as a primary therapy or an adjunct to soft tissue reconstruction. Wounds were monitored fortnightly, limb circumference measured and patient satisfaction assessed by a questionnaire. All 4 patients healed within 6 weeks of Prevena application. Results: No cases developed wound complications. Limb oedema, assessed by circumference, decreased in all patients within 2 weeks. All patients were satisfied with the Prevena Restor Bella.FormTM with regards to comfort and mobility. Conclusions: Prevena Restor Bella.FormTM demonstrated clinical effectiveness in all patients, and was universally well tolerated. Level of Evidence: IV

Managing incisional wounds with Prevena VAC therapy in lower-extremity vascular surgery: A comparative study.

Vascular surgical site infections have been reported with an overall incidence of 5-10% for patients undergoing arterial interventions and as high as 10-20% for lower-limb bypass grafting procedures. Given that vascular surgery patients are known to be at a higher risk of postoperative wound infections and other complications, our objective was to evaluate a potential method to reduce such complications. This study compares the rate of wound healing complications between incisional negative pressure wound therapy (NPWT) and conventional dressings in vascular surgery patients with infra-inguinal incisions. The primary endpoint is complete closure of the wound at the 2-week follow-up appointment. Secondary endpoints include frequency infections requiring antibiotics, need for wound revision, and wound dehiscence. A prospective cohort study with retrospective control group was performed following infra-inguinal vascular surgeries for peripheral arterial disease at the Mount Carmel Health System. The patients included in this study were those who underwent a lower-extremity vascular procedure with primary closure of an incision distal to the groin between January 2014 and July 2018. Patients that had received an infra-inguinal incision with primary closure were included. Patients in the experimental group who had a Prevena Wound VAC were compared with a retrospectively obtained control arm treated with conventional dressings. Data regarding wound healing and complications, specifically infections and wound dehiscence, were obtained. A total of 201 patients were recruited in our study: 64 in the Prevena group and 137 in the control group. There was a significant reduction in the number of open wounds in the Prevena group compared to the control group at the 2-week follow-up (10.9% Prevena vs 33.6% control; p = .0005). When evaluated in aggregate, there was a statistically significant reduction in the number of patients who succumbed to any complication in the Prevena arm compared with traditional dressings (13 (20.3%) Prevena vs 72 (52.6%) control; p < .0001). The results of our study suggest there should be a significant consideration for the use of NPWT as a prophylactic measure to reduce the risk of wound complications of primarily closed infra-inguinal incisions in vascular surgery patients following common vascular procedures. Its use is particularly effective for patients at enhanced risk of infection, especially those with poor vascularization from BMI, smoking, and diabetes. This leads to decreased trends in antibiotic use, ED visits, readmissions, and surgical revisions, which translates to decreased utilization of hospital resources and economic burden.

Incisional Negative Pressure Wound Therapy After Revascularisation Surgery in Patients with Peripheral Arterial Disease: A Randomised Trial (PICO-Vasc Study)

This study assessed the potential benefits of using incisional negative pressure wound therapy (iNPWT) for patients undergoing revascularisation due to peripheral arterial disease. A prospective randomised controlled trial was conducted to compare the inguinal application of iNPWT vs. standard surgical dressings. Patients were enrolled from February 2021 to November 2022. A total of 133 groin incisions were randomised (66 intervention group, 67 control group). Randomisation sequence was carried out by permuted blocks and allocation assigned by opening opaque envelopes once the revascularisation procedure had finished. Wound healing and complication rates were assessed at post-operative days 5, 14, and 30. Primary and secondary endpoints were: 30 day post-operative surgical site infection (SSI) and surgical site occurrence (SSO) rates, defined as a surgical wound complication other than an SSI. Post-operative SSI was defined according to the Centers for Disease Control and Prevention criteria. Surgical site occurrence included: wound dehiscence, seroma or lymphocoele, haematoma, and lymphorrhagia. The study was registered at ClinicalTrails.gov database (NCT04840576) and reported according to the CONSORT guidelines. Incisional negative pressure wound therapy did not modify the 30 day inguinal SSI and SSO rates (16.7% vs. 20.9% and 37.9% vs. 44.8%; p = .53, RR 0.999, 95% confidence interval [CI] 0.52 - 1.88 and p = .42, RR 1.29, 95% CI 0.89 - 1.86, respectively). It reduced the early SSO rate (19.7% vs. 35.8%; p = .044, RR 1.45, 95% CI 1.047 - 2.013) and post-operative seroma (4.6% vs. 19.4%; p = .014, RR 1.73, 95% IC 1.296 - 2.397). There were no differences in SSI and SSO rates, although statistically significant reductions in early SSO rates and seroma were found in the intervention group.

412 Incisional Negative Pressure Wound Therapy Following Posterior Instrumented Spinal Fusion: A Single Surgeon’s Experience and Cost-Benefit Analysis

INTRODUCTION: Surgical site infections (SSIs) following spine surgery are associated with significant morbidity and resource utilization. METHODS: We retrospectively reviewed all patients who received posterior instrumented spinal fusion by the senior author between July 2017 and December 2019 at a Level I trauma center. Statistical analysis was performed using Chi-square and Student’s t-tests. RESULTS: A total of 85 patients with standard surgical dressings and 144 patients with iNPWT were included for analysis. Patients in the iNPWT group were significantly older (61.8 vs. 58.5 years, p = 0.042) and more likely to be diabetic (36.8% vs. 23.5%, p = 0.037). Surgeries in the iNPWT group were associated with significantly greater blood loss (1298 mL vs. 998 mL, p = 0.036) and involved more instrumented levels (6.6 vs. 4.9, p &lt; 0.0001). Prophylactic iNPWT use was associated with significantly lower rates of wound dehiscence (21.5% vs. 34.1%, p = 0.036) and SSI requiring operative treatment (8.3% vs. 21.2%, p = 0.005). The incidence of wound dehiscence requiring operative wound revision was lower with iNPWT (14.6% vs. 24.7%, p = 0.056), though it did not reach statistical significance. Number needed to treat (NNT) with iNPWT to prevent one SSI was 7.79. The cost of preventing one operative SSI was $5,096. Cost-benefit analysis demonstrated a potential mean savings of $26,149 per operative SSI and $326,862 per 100 patients undergoing posterior instrumented spinal fusion with iNPWT. CONCLUSIONS: Prophylactic iNPWT use significantly reduced rates of wound dehiscence, SSI requiring operative treatment, and affords a potential SSI-related cost savings of $326,862 per 100 patients treated.

Closed-incision negative-pressure wound therapy reduces superficial surgical site infections after open colon surgery: an NSQIP Colectomy Study

The use of closed incision negative pressure wound therapy (iNPWT) has increased in the last decade across surgical fields, including colectomy. Compare postoperative outcomes associated with use of (iNPWT) following open colectomy from a large national database. A retrospective review of patients who underwent operations from 2015-2020 was performed using National Surgical Quality Improvement Program (NSQIP) Targeted Colectomy Database. Intraoperative placement of iNPWT was identified using Current Procedural Terminology (CPT) codes in patients undergoing open abdominal operations with closure of all wound layers including skin. Propensity score matching was performed to define a control group who underwent closure of all wound layers without iNPWT. Patients were matched in a 1:4 (iNPWT vs. control) ratio and postoperative rates of superficial, deep and organ-space SSI, wound disruption, and readmission. Between 2015-2020, iNPWT was used in 483 (0.6%) undergoing open colectomies. A matched cohort of 1884 was selected. Patients with iNPWT had longer median operative time (170 [IQR 129-232] vs. 161[IQR:114-226] minutes, p<0.05) (Table 2). Compared to patients without iNPWT, Patients with iNPWT experienced a lower rate of 30-day superficial incisional SSI (3% vs. 7%, p<0.05) and readmissions (10% vs 14%; p < 0.05). iNPWT did not decrease risk of deep SSI, organ-space SSI, or wound disruption. Although there is a slightly increased operative time, utilization of iNPWT in open colectomy is associated with lower odds of superficial SSI and 30-day readmission. This suggests that iNPWT should be routinely utilized in open colon surgery to improve patient outcomes.

Combining Skin Adhesive Tape with Incisional Negative Pressure Wound Therapy for Gaping Spinal Wound Dehiscence: A Case Report

The authors present a case report of spinal wound dehiscence successfully treated with a combination of incisional negative pressure wound therapy and skin adhesive tapes. This article discusses the technique, benefits and limitations, and finally provides a proposed mechanism of action.

Effectiveness of Specific Single-Use Incisional Negative Pressure Wound Therapy (PICO System) After Major Lower Extremity Amputation

Lower extremity amputation (LEA), particularly in patients with diabetes or peripheral vascular disease, often results in complications such as surgical site infections (SSIs) and wound dehiscence. This study examined whether utilizing the portable and user-friendly PICO system (Smith and Nephew Medical Ltd, Hull, UK) as incisional negative-pressure wound therapy can reduce post-LEA complications. This study was conducted at a Japanese tertiary medical center and involved a retrospective analysis of LEA cases (n = 32) between January 2021 and December 2022. The PICO dressing group (n = 16) was compared to the conventional dressing group (n = 16) for post-LEA wound management. The primary outcome was the incidence of postoperative wound complications, including SSI and wound dehiscence, within 15 days of LEA. Superficial/deep SSI and wound dehiscence occurred less frequently in the PICO dressing group than in the conventional dressing group (12.5% vs 43.8%; p = .054). There were no cases of deep SSIs in the PICO dressing group. Although this study has limitations owing to its retrospective design and small sample size, the results suggest the potential of the PICO system for improving outcomes in post-LEA wound management.

Multicenter parallel randomized trial evaluating incisional negative pressure wound therapy for the prevention of surgical site infection after lower extremity bypass

ObjectiveIncisional negative pressure wound therapy (iNPWT) applied over all incisions after lower extremity bypass in the prevention of surgical site infections (SSIs) is unclear. The primary and secondary aims of this study were to investigate if prophylactic iNPWT after the elective lower extremity bypass prevents SSI and other surgical wound complications. MethodsThis was a multicenter, parallel, randomized controlled trial. Patients undergoing elective lower extremity bypass in 3 hospitals were randomized to either iNPWT or standard dressings. SSIs or other wound complications were assessed within the first 90 days by wound care professionals blinded to the randomized result. The validated Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissues, Isolation of bacteria, and Stay (ASEPSIS) score was used to objectively assess the wounds. ASEPSIS score ≥21 is defined as an SSI. Unilateral and bilateral groups were analyzed with the Fisher exact test and the McNemar test, respectively. ResultsIn the unilateral group (n = 100), the incidence of SSI in the iNPWT group was 34.9% (15/43), compared with 40.3% (23/57) in the control group, according to the ASEPSIS score (P = .678). In the bilateral group (n = 7), the SSI rate was 14.3% (1/7) in the iNPWT group compared with 14.3% (1/7) in the control group (P = 1.00). In the unilateral group, there was a higher wound dehiscence rate in the control group (43.9%) compared with the iNPWT group (23.3%) (P = .0366). No serious iNPWT-related adverse events were recorded. ConclusionsThere was no reduction of SSI rates in leg incisions with iNPWT compared with standard dressings in patients undergoing elective lower extremity bypass, whereas iNPWT reduced the incidence of wound dehiscence.

Incisional negative pressure wound therapy may not protect against post-operative surgical site complications in bicondylar tibial plateau fractures.

To determine if incisional negative pressure wound therapy is protective against post-operative surgical site complications following definitive fixation of bicondylar tibial plateau fractures. A retrospective analysis of patients diagnosed with an acute bicondylar tibial plateau fracture (AO/OTA 41-C) undergoing ORIF from 2010 to 2020 was performed. Patients received either a standard sterile dressing (SD) or incisional negative pressure wound therapy (iNPWT). Primary outcomes included surgical site infection, osteomyelitis, and wound dehiscence. Secondary outcomes included non-union and return to the operating room. Multivariate logistic regression analyses were performed. 180 patients were included and 22% received iNPWT (n = 40) and 78% received standard dressings (n = 140). iNPWT was more common in active smokers (24.7% vs. 19.3%, p = 0.002) and the SD group was more likely to be lost to follow up (3.6% vs. 0%, p = 0.025). iNPWT was not protective against infection or surgical site complications, and in fact, was associated with higher odds of post-operative infection (OR: 8.96, p = 0.005) and surgical site complications (OR:4.874, p = 0.009) overall. Alcohol abuse (OR: 19, p = 0.005), tobacco use (OR: 4.67, p = 0.009), and time to definitive surgery (OR = 1.21, p = 0.033) were all independent risk factors for post-operative infection. In this series of operatively treated bicondylar tibial plateau fractures, iNPWT did not protect against post-operative surgical site complications compared to conventional dressings. Tobacco use, alcohol abuse, and time to definitive surgery, were independent risk factors for post-operative infection. Further studies are needed to determine if iNPWT offers a protective benefit in exclusively high-risk patients with relevant medical and social history.

Closed incision negative pressure wound therapy following pancreaticoduodenectomy for prevention of surgical site infections in high-risk patients.

Surgical site infection (SSI) is one of the most common sources of morbidity after pancreaticoduodenectomy. Surgical site infections are associated with readmissions, prolonged length of stay, delayed initiation of adjuvant chemotherapy and negative effects on quality of life. Incisional vacuum-assisted closure (iVAC) devices applied on closed incisions may reduce SSI rates. The objective of this retrospective review is to evaluate the impact of iVAC on SSI rate after pancreaticoduodenectomy. A cohort of patients undergoing pancreaticoduodenectomy at a single institution who had at least 1 risk factor for SSI and who received an iVAC were compared with a historical cohort of high-risk patients who received conventional dressings after pancreaticoduodenectomy. The primary outcome was incidence of SSI within 30 days, abstracted from chart review. Secondary outcomes were 30-day readmission, 90-day mortality, rate of postoperative pancreatic fistula and rate of delayed gastric emptying. In total, 175 patients were included, of whom 61 received an iVAC. The incidence of SSI was 13% (8 of 61 patients) and 16% (18 of 114 patients) in the iVAC and conventional dressing groups, respectively (odds ratio 0.81, 95% confidence interval 0.33-1.98). Preoperative biliary drainage was the most frequent SSI risk factor. Binary logistic regression using SSI as the outcome demonstrated no significant association with iVAC use when adjusted for SSI risk factors. There were no differences in rates of postoperative pancreatic fistula, delayed gastric emptying or 90-day mortality. This report describes the outcomes of the integration of iVAC devices into routine clinical practice at a high-volume institution. Application of this device after pancreaticoduodenectomy for patients at elevated risk of SSI was not associated with a reduction in the rate of SSIs.

Incisional Negative Pressure Wound Therapy Impacts on Wound Healing and Quality of Life Following Lower Extremity Amputation: A Prospective Randomized Control Trial

Incisional Negative Pressure Wound Therapy Impacts on Wound Healing and Quality of Life Following Lower Extremity Amputation: A Prospective Randomized Control Trial

A Novel Treatment Protocol to Improve Outcomes with Transtibial Amputations

Category: Diabetes; Other Introduction/Purpose: A retrospective case series study was performed to evaluate the outcomes and risk factors of transtibial amputations (TTA) using a novel post operative treatment protocol. The study hypothesis is that a novel post operative treatment protocol could improve outcomes for TTAs. All patients who underwent a TTA from July 2019 through December 2022 were treated with this protocol. Outcomes identified included time to prosthetic fitting after surgery and complications including wound dehiscence and mortality at 30 days. Risk factors were also identified for the patients in this case series study. Methods: The novel post operative protocol includes a circumferential incisional negative pressure wound therapy (CiNPWT) dressing that covered with a novel residual limb shrinker (nRLS) and a limb protector (LP) applied after incision closure. The CiNPWT and nRLS were removed at the first follow up visit. Then the nRLS was applied as the primary dressing directly against the incision covering the residual limb. The nRLS was changed for wound cleansing and was sequentially decreased in size to facilitate consolidation of the residual limb. Results: There were 433 surgeries performed on 304 patients. This included 222 (73%) men and 81 (27%) women with an average age of 67 years (41-90 years). There were 129 revision surgeries including 25 above-the-knee amputations (AKA). The average time to prosthetic fitting for TTA was 8 weeks. The average study group BMI was 32 kg/m2, A1c 8.7%, albumin 2.6 g/dL and neutrophil to lymphocyte ratio (NLR) 4.9. Traumatic wound dehiscence from falls represented 26% of revision surgeries. Mortality at 30 days was 3.2% for all study participants. The early death average age was 70 years (41-90 years), 73% with end stage renal disease (ESRD) and 82% with diabetes mellitus (DM). Conclusion: The novel protocol for transtibial amputations decreased the 30 day mortality to 3.2% from a national average of 13.5%. The average time to prosthetic fitting was 8 weeks for the study group compared to 16 weeks for US Department of Veterans Affairs amputations. The early death group’s average albumin of 2.15 g/dL with a NLR of 8.9. The study demonstrated that a novel postoperative protocol may improve outcomes in transtibial amputations and that a few simple blood values may provide an indication of the diminished overall physiologic health of this patient population.

Incisional negative pressure wound therapy for the prevention of surgical site infection: an up-to-date meta-analysis and trial sequential analysis

The evidence on prophylactic use of negative pressure wound therapy on primary closed incisional wounds (iNPWT) for the prevention of surgical site infections (SSI) is confusing and ambiguous. Implementation in daily practice is impaired by inconsistent recommendations in current international guidelines and published meta-analyses. More recently, multiple new randomised controlled trials (RCTs) have been published. We aimed to provide an overview of all meta-analyses and their characteristics; to conduct a new and up-to-date systematic review and meta-analysis and Grading of Recommendations Assessment, Development and Evaluation (GRADE) assessment; and to explore the additive value of new RCTs with a trial sequential analysis (TSA). PubMed, Embase and Cochrane CENTRAL databases were searched from database inception to October 24, 2022. We identified existing meta-analyses covering all surgical specialties and RCTs studying the effect of iNPWT compared with standard dressings in all types of surgery on the incidence of SSI, wound dehiscence, reoperation, seroma, hematoma, mortality, readmission rate, skin blistering, skin necrosis, pain, and adverse effects of the intervention. We calculated relative risks (RR) with corresponding 95% confidence intervals (CI) using a Mantel-Haenszel random-effects model. We assessed publication bias with a comparison-adjusted funnel plot. TSA was used to assess the risk of random error. The certainty of evidence was evaluated using the Cochrane Risk of Bias-2 (RoB2) tool and GRADE approach. This study is registered with PROSPERO, CRD42022312995. We identified eight previously published general meta-analyses investigating iNPWT and compared their results to present meta-analysis. For the updated systematic review, 57 RCTs with 13,744 patients were included in the quantitative analysis for SSI, yielding a RR of 0.67 (95% CI: 0.59-0.76, I2=21%) for iNPWT compared with standard dressing. Certainty of evidence was high. Compared with previous meta-analyses, the RR stabilised, and the confidence interval narrowed. In the TSA, the cumulative Z-curve crossed the trial sequential monitoring boundary for benefit, confirming the robustness of the summary effect estimate from the meta-analysis. In this up-to-date meta-analysis, GRADE assessment shows high-certainty evidence that iNPWT is effective in reducing SSI, and uncertainty is less than in previous meta-analyses. TSA indicated that further trials are unlikely to change the effect estimate for the outcome SSI; therefore, if future research is to be conducted on iNPWT, it is crucial to consider what the findings will contribute to the existing robust evidence. Dutch Association for Quality Funds Medical Specialists.

Effectiveness of incisional negative pressure wound therapy after major lower extremity amputation: a randomised controlled trial.

The aim was to study the effect of incisional negative pressure wound therapy (iNPWT) in wound healing compared with standard sterile gauze dressings after major lower extremity amputation in patients with peripheral arterial disease (PAD). This prospective, randomised controlled trial included 50 patients undergoing major lower extremity amputations for PAD. Patients were randomised into iNPWT and standard dressing groups. The patency of blood vessels at the level of the stump was ensured with or without revascularisation. The primary outcome was wound-related complications such as surgical site infection (SSI), wound dehiscence, seroma/haematoma formation or the need for revision amputation. The secondary outcome was the time taken for the eligibility of prosthesis placement. It was found that only 12% of the patients in the iNPWT group had SSI compared with 36% in the standard dressing group (p = 0.047). Rates of wound dehiscence, seroma/haematoma formation and revision amputation were decreased in the iNPWT group but this was not statistically significant (p > 0.05). There was a significant reduction in the time taken for eligibility of prosthesis placement in the iNPWT group (5.12 ± 1.53 vs 6.8 ± 1.95 weeks, p = 0.002). iNPWT is effective in reducing the incidence of SSI and the time taken for rehabilitation in patients undergoing major lower limb amputation due to PAD.

Efficacy of incisional negative pressure therapy in preventing post-sternotomy wound complications

BackgroundSternal wound infections represent a source of significant morbidity and mortality following median sternotomy. The use of incisional negative pressure wound therapy in prevention has yet to be elucidated. MethodsA retrospective study was conducted before and after a universal wound care protocol was implemented including the prophylactic use of negative pressure wound therapy (NPWT). The primary endpoint was sternal infections within 90 days of the index operation. ResultsIn the control period, there was a 3.0% rate of sternal infection within 90 days compared to 0.8% in the intervention period (p < 0.001). An odds ratio of 0.25 (95% confidence interval 0.11, 0.57; p < 0.001) in the intervention period as compared to the control period was demonstrated. ConclusionsThe use of a standardized wound care protocol including the universal application of NPWT for patients undergoing cardiac surgery with median sternotomy was an independent predictor of decreased rates of sternal infection.

Closed Incision Negative Pressure Wound Therapy Assisted Full Thickness Graft Aite Wound Dressing to Prevent Surgical Site Infection

Closed incision Negative Pressure Wound Therapy (CiNPWT) which is a topical application of negative pressure over the wound plays a key role in healing and prevention of surgical site infections. We have used full thickness graft following post burn contracture release. We then applied negative pressure wound therapy over to this flap to assess its efficacy and safety in aiding healing.

Cost-effectiveness of closed incision negative pressure wound therapy in preventing surgical site infection among obese women giving birth by caesarean section: An economic evaluation (DRESSING trial).

There is growing evidence regarding the potential of closed incision negative pressure wound therapy (ci-NPWT) to prevent surgical site infections (SSIs) in healing wounds by primary closure following a caesarean section (CS). To assess the cost-effectiveness of ci-NPWT compared to standard dressings for prevention of SSI in obese women giving birth by CS. Cost-effectiveness and cost-utility analyses from a health service perspective were undertaken alongside a multicentre pragmatic randomised controlled trial, which recruited women with a pre-pregnancy body mass index ≥30 kg/m2 giving birth by elective/semi-urgent CS who received ci-NPWT (n=1017) or standard dressings (n=1018). Resource use and health-related quality of life (SF-12v2) collected during admission and for four weeks post-discharge were used to derive costs and quality-adjusted life years (QALYs). ci-NPWT was associated with AUD$162 (95%CI -$170 to $494) higher cost per person and an additional $12 849 (95%CI -$62 138 to $133 378) per SSI avoided. There was no detectable difference in QALYs between groups; however, there are high levels of uncertainty around both cost and QALY estimates. There is a 20% likelihood that ci-NPWT would be considered cost-effective at a willingness-to-pay threshold of $50 000 per QALY. Per protocol and complete case analyses gave similar results, suggesting that findings are robust to protocol deviators and adjustments for missing data. ci-NPWT for the prevention of SSI in obese women undergoing CS is unlikely to be cost-effective in terms of health service resources and is currently unjustified for routine use for this purpose.