Efficacy of two widely used negative pressure wound therapy devices in preventing obstetric surgical site infections in obese patients: A comparison of randomized controlled trials

One of the main complications of cesarean sections is surgical site infections (SSIs), which can lead to increased healthcare costs, maternal morbidity and mortality, particularly in obese patients. Prophylactic incisional negative pressure wound therapy (iNPWT) has emerged as a successful intervention in patients at high risk for SSIs. This systematic literature review compares two systems (incision management system [IMS]* and a single-use NPWT [sNPWT]†) widely used to treat primarily closed cesarean wounds.

In June 2020, the PubMed and EMBASE databases were searched for randomized controlled trials comparing the use of either of the two iNPWT systems (intervention) with standard dressings (control) for cesarean delivery wounds. Two separate meta-analyses were performed to compare SSI rates between the systems and standard dressing.

Seven studies with comparable patient populations and similar risk of bias were identified. The meta-analysis of four published articles1-4 with IMS (402 and 401 patients in the intervention and control groups, respectively) revealed a trend for lower SSI rates as compared with standard dressing, which did not reach statistical significance (risk ratio [RR], 0.81; 95% confidence interval [CI], 0.51-1.30; p=0.3888). Meta-analysis of two published articles5,6 and one abstract7 pertaining to sNPWT (536 and 547 patients in the intervention and control groups, respectively) showed a statistically significant 43% reduction in the risk of SSI (RR, 0.57; 95% CI, 0.36-0.91; p=0.0183) as compared with standard dressing.

As the two meta-analyses are comparable in overall risk of bias assessments, patient numbers, and surgical procedure, this study provides an accurate and generalizable comparative evidence of the efficacy of using IMS and sNPWT in treating cesarean delivery incisions in obese women.

Trademarked Items (if applicable): * PREVENA‚Ñ¢ Incision Management System (KCI Inc., San Antonio, Texas)
† PICO™ Single-Use Negative Pressure Wound Therapy System (Smith+Nephew, Hull, United Kingdom)

References (if applicable): 1. Ruhstaller K, Downes KL, Chandrasekaran S, Srinivas S, Durnwald C. Prophylactic Wound Vacuum Therapy after Cesarean Section to Prevent Wound Complications in the Obese Population: A Randomized Controlled Trial (the ProVac Study). American Journal of Perinatology. 2017;34(11):1125-1130.

2. Gunatilake RP, Swamy GK, Brancazio LR, et al. Closed-Incision Negative-Pressure Therapy in Obese Patients Undergoing Cesarean Delivery: A Randomized Controlled Trial. AJP reports. 2017;7(3):e151-e157.

3. Wihbey KA, Joyce EM, Spalding ZT, et al. Prophylactic Negative Pressure Wound Therapy and Wound Complication After Cesarean Delivery in Women With Class II or III Obesity: A Randomized Controlled Trial. Obstetrics and Gynecology. 2018;132(2):377-384.

4. Hussamy DJ, Wortman AC, McIntire DD, et al. Closed Incision Negative Pressure Therapy in Morbidly Obese Women Undergoing Cesarean Delivery: A Randomized Controlled Trial. Obstetrics and Gynecology. 2019;134(4):781-789.

5. Hyldig N, Vinter C, Kruse M, et al. Prophylactic incisional negative pressure wound therapy reduces the risk of surgical site infection after caesarean section in obese women: a pragmatic randomised clinical trial. BJOG: an international journal of obstetrics and gynaecology. 2018; 126(5):628-635.

6. Chaboyer W, Anderson V, Webster J, et al. Negative Pressure Wound Therapy on Surgical Site Infections in Women Undergoing Elective Caesarean Sections: A Pilot RCT. Healthcare (Basel, Switzerland). 2014;2(4):417-428.

7. Tuuli M, Martin S, Stout M, et al. Pilot randomized trial of prophylactic negative pressure wound therapy in obese women after cesarean delivery. 37th Annual Meeting of the Society for Maternal-Fetal Medicine: The Pregnancy Meeting. 2017; Las Vegas, NV, United States.