Reviewed by S. Shaefer Spires, MD, Duke University School of Medicine
There is an increased risk of surgical site infections after cesarean delivery in obese women. The addition of negative pressure wound therapy to a wound after being closed with sutures has been proposed to reduce the risk of SSIs in this population. Tuuli et al. performed a randomized clinical trial evaluating this intervention in over 1600 patients in 4 academic medical centers and 2 community medical centers. The outcome of superficial or deep surgical site infection was diagnosed in 29 (3.6%) in negative pressure group and 27 (3.4%) in the standard group (difference, 0.36%, 95% CI, -1.46% to 2.19%, p=0.70). However, adverse skin reactions were significantly more frequent in the negative pressure group (7.0% vs 0.6%; difference, 6.96%; 95% CI, 1.86% to 12.03%; p<0.001). Therefore, the study was terminated early, after 1624 of the anticipated 2850 participants were recruited when a planned interim analysis showed these increased adverse events and futility in the primary outcome. The severe skin reactions included blisters (48%), bleeding (16%), erythema (18%), and other manifestations (25%). These findings do not support the routine use of negative pressure wound therapy in this cohort and highlight the importance of rigorous study of medical interventions even when they have sound scientific plausibility.
Tuuli MG, Liu J, Tita ATN, et al. Effect of Prophylactic Negative Pressure Wound Therapy vs Standard Wound Dressing on Surgical-Site Infection in Obese Women After Cesarean Delivery: A Randomized Clinical Trial. JAMA. 2020;324(12):1180