Systematic Review and Meta-analysis of Prophylactic Negative Pressure Wound Therapy Devices for Major Lower Extremity Amputations.

Abstract

Major lower extremity amputations are commonly performed for limb threatening ischaemia and uncontrollable infection. The dysvascular and diabetic cohort have multiple risk factors for post-operative wound complications. Prophylactic incisional negative pressure wound therapy (NPWT) has been associated with significantly lower rates of surgical site infection (SSI). The aim of this updated systematic review was to examine the impact of NPWT on outcomes after major amputations. PubMed, Scopus, Embase, conference abstracts, and trial registries were searched. Studies of all methodologies comparing NPWT applied to closed incisions with dry dressings after major amputations were eligible. The meta-analyses compared the relative risk (RR) of overall wound complications and SSIs between NPWT and standard care. Risk of bias was assessed using the Methodological Index for Non-Randomised Studies (MINORS) criteria and Cochrane Risk of Bias 2 tool. Outcome certainty was assessed using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) criteria. Nine studies were identified, including three randomised controlled trials (RCTs) and six cohort studies. Overall study quality was moderate to poor, with very low outcome certainty on GRADE analyses. Seven hundred and forty-nine patients were included, with 336 receiving NPWT and 413 standard care. The pooled rate of wound complications was 16.0% (95% confidence interval [CI] 9.5 - 24.0%) for NPWT and 44.6% (95% CI 29.0 - 60.9%) for standard care. Prophylactic NPWT was associated with a statistically significantly lower composite complication rate (RR 0.42, 95% CI 0.29 - 0.60; p < .001; I² = 0%) and SSI rate (RR 0.51, 95% CI 0.31 - 0.83; p = .007; I² = 0%) compared with standard care. Although the quality of the included studies was variable, prophylactic NPWT may reduce wound complications after major amputation. Further adequately powered RCTs are needed to clarify the benefits and cost effectiveness of NPWT in this cohort, including whether it should be used routinely or selectively.