Evaluating a Single use Closed Incision Negative Pressure Therapy System over Closed Groin Incisions Following Vascular Surgery: Meta-analysis of Comparative Trials

Abstract

Introduction: Surgical site complications pose a significant risk for patients. With groin incisions, surgical site complications may result in limb loss and increased risk of death, with rates as high as 44%. Closed incision negative pressure therapy (ciNPT) has been associated with decreased SSI rates in published literature A number of recent publications have compared SSI rates between ciNPT and traditional dressings following vascular surgery with groin incisions. This meta-analysis examines the effect of a the PREVENA™ Incision Management System (KCI, an ACELITY Company, San Antonio, TX) in reducing SSIs versus traditional dressings over closed groin incisions following vascular surgery. Methods: A systematic literature search using PubMed, OVID, EMBASE, and QUOSA was performed, focused for publications between January 1, 2005 and December 31, 2018. The literature search was limited to PREVENA™ Therapy use over closed groin incisions in randomized controlled trials (RCTs). Inclusion criteria included abstract or manuscript written in English, published or unpublished studies, RCTs, ciNPT usage over closed groin incisions in vascular surgery, comparison of ciNPT use and traditional dressings, study endpoint/outcome of SSI, and study population of >10. Characteristics of study participants, surgical procedure, type of dressing used, duration of treatment, incidence of SSI, and length of follow-up were extracted. Weighted risk 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. Results: A total of 615 articles were identified from the literature search. After removal of excluded studies and duplicates, 6 RCT studies were available for analysis. Four of the 6 RCTs restricted their inclusion criteria to patient deemed at high risk for SSI development. In these studies, a total of 362 patients received ciNPT, and 371 patients received traditional dressings (control group). SSI events occurred in 41 ciNPT patients and 107 control patients. The heterogeneity test was non-significant (p>0.05). The meta-analysis showed a highly significant effect in favor of ciNPT (RR= 0.41, 95% CI 0.29 to 0.57, p< 0.00001). One limitation of this study is the varying RCT inclusion/exclusion criteria, such as differences in procedure types, and patient populations (some RCTs restricted to patients at high risk for complications). Conclusion: For this meta-analysis, ciNPT usage demonstrated a statistically significant reduction in the incidence of SSI relative to traditional dressings in patients undergoing vascular surgery with groin incisions. Disclosure: Alexander Gombert received travel grants from Acelity. All further authors have nothing to disclose.