Prophylactic Negative Pressure Wound Therapy After Laparotomy for Gynecologic Surgery: A Randomized Controlled Trial
Mario M Leitao Jr, Qin C Zhou, Maria B Schiavone, Renee A Cowan, Evan S Smith, Alexia Iasonos, Mitchell Veith, Michael Rafizadeh, Katherine Curran, Bhavani Ramesh, Kaity Chang, Dennis S Chi, Yukio Sonoda, Amy K Brown, Jonathan A Cosin, Nadeem R Abu-Rustum, Martin A Martino, Jennifer J Mueller, Kara Long Roche, Elizabeth L Jewell, Vance Broach, Nicholas C Lambrou, John P Diaz, Oliver Zivanovic, Mario M Leitao Jr, Qin C Zhou, Maria B Schiavone, Renee A Cowan, Evan S Smith, Alexia Iasonos, Mitchell Veith, Michael Rafizadeh, Katherine Curran, Bhavani Ramesh, Kaity Chang, Dennis S Chi, Yukio Sonoda, Amy K Brown, Jonathan A Cosin, Nadeem R Abu-Rustum, Martin A Martino, Jennifer J Mueller, Kara Long Roche, Elizabeth L Jewell, Vance Broach, Nicholas C Lambrou, John P Diaz, Oliver Zivanovic
Abstract
Objective: To estimate the effectiveness of prophylactic negative pressure wound therapy in patients undergoing laparotomy for gynecologic surgery.
Methods: We conducted a randomized controlled trial. Eligible, consenting patients, regardless of body mass index (BMI), who were undergoing laparotomy for presumed gynecologic malignancy were randomly allocated to standard gauze or negative pressure wound therapy. Patients with BMIs of 40 or greater and benign disease also were eligible. Randomization, stratified by BMI, occurred after skin closure. The primary outcome was wound complication within 30 (±5) days of surgery. A sample size of 343 per group (N=686) was planned.
Results: From March 1, 2016, to August 20, 2019, we identified 663 potential patients; 289 were randomized to negative pressure wound therapy (254 evaluable participants) and 294 to standard gauze (251 evaluable participants), for a total of 505 evaluable patients. The median age of the entire cohort was 61 years (range 20-87). Four hundred ninety-five patients (98%) underwent laparotomy for malignancy. The trial was eventually stopped for futility after an interim analysis of 444 patients. The rate of wound complications was 17.3% in the negative pressure wound therapy (NPWT) group and 16.3% in the gauze group, absolute risk difference 1% (90% CI -4.5 to 6.5%; P=.77). Adjusted odds ratio controlling for estimated blood loss and diabetes was 0.99 (90% CI 0.62-1.60). Skin blistering occurred in 33 patients (13%) in the NPWT group and in three patients (1.2%) in the gauze group (P<.001).
Conclusion: Negative pressure wound therapy after laparotomy for gynecologic surgery did not lower the wound complication rate but did increase skin blistering.
Clinical trial registration: ClinicalTrials.gov, NCT02682316.
Funding source: The protocol was supported in part by KCI/Acelity.
Conflict of interest statement
Financial Disclosure Dr. Leitao reports personal fees from Intuitive Surgical, Inc. and JNJ/Ethicon; Dr. Jewell reports personal fees from Covidien/Medtronic; Dr. Chi reports personal fees from Bovie Medical Co., Verthermia Inc. (now Apyx Medical Corp.), C Surgeries, and Biom ‘Up, as well as previous stock ownership in Intuitive Surgical, Inc. and TransEnterix, Inc. Dr. Abu-Rustum reports grants from Stryker/Novadaq, Olympus, and GRAIL. Dr. Iasonos reports personal fees from Mylan. Dr. Martino is a patient safety consultant for Intuitive, Surgical, Inc., JNJ, Medtronic, and CMR, as well as an education speaker for GlaxoSmithKline and a peer reviewer for UpToDate. Dr. Lambrou is a consultant for Ethicon and Intuitive Surgical, Inc. Dr. Diaz is a speaker and has research grant support from Merck and AstraZeneca, and he is a consultant for ConMed. Dr. Cosin is a consultant for Medtronic. The other authors did not report any potential conflicts of interest.
Copyright © 2021 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.
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Source: PubMed