Incisional Negative Pressure Wound Therapy: Metod to reduce the risk of wound infection in obese women following caesarean section

Background: Obese women undergoing caesarean section are at increased risk of surgical wound complications, which may lead to delayed recovery, pain, reduced quality of life, and increased health care cost. The aim of this study is to evaluate the effect of incisional Negative Pressure Wound Therapy (iNPWT) applied prophylactically following caesarean section compared with standard postoperative dressings in obese women undergoing caesarean section.
Method: This study is designed as an unblinded, pragmatic, parallel randomised multicenter trial, with a 1:1 allocation. A computer random number generator are used to allocate the participants into one of two groups (iNPWT vs. standard dressing), stratified by centre and type of CS. The study is conducted at five public hospitals located in three regions of Denmark. Interim analyses will be preformed along the trial using the group sequential method. The analyses will be performed when sample size reaches 179, 357, 535, 713, and 891, respectively.
Population: women with a pre-gestational BMI ≥ 30 undergoing planned or emergency caesarean section. The iNPWT or standard dressings is applied immediately following operation. In the intervention group the therapy will be left in situ for five days. In the control group the dressing will be left in situ for at least 24 hours as standard procedure. Follow-up is 30 days.
Results: The study is on going. The first 179 participants are about to be analysed. Overall we expect to find a 50% reduction of wound infection when using iNPWT compared to standard postoperative dressings in this high-risk subpopulation.