The routine use of prophylactic negative pressure wound therapy after cesarean delivery in women with obesity is not supported, as it did not significantly reduce the risk of surgical site infection (SSI) compared with standard wound dressing, according to data published in JAMA.
Study authors conducted a multicenter, randomized trial from February 2017 through November 2019 at 4 academic and 2 community hospitals across the United States (ClinicalTrials.gov Identifier: NCT03009110) to evaluate whether prophylactic negative pressure wound therapy reduces SSI following cesarean delivery in women with obesity.
In total, 1624 women (mean age, 30.4 years; mean BMI, 39.5) undergoing planned or unplanned cesarean deliveries were randomly assigned to either a standard wound dressing (n=808) or a negative pressure device applied immediately after repair of the surgical incision (n=816).
Superficial or deep SSI occurred in 29 (3.6%) and 27 (3.4%) participants in the negative pressure group and standard care groups, respectively (difference, 0.36%; 95% CI, -1.46% to 2.19%; P =.70). No statistically significant difference was noted between groups in 25 of 30 prespecified secondary end points, including other wound complications (2.6% vs 3.1%; difference, -0.53%; 95% CI, -1.93% to 0.88%; P =.46) and composite of SSIs and other wound complications (6.5% vs 6.7%; difference, -0.27%; 95% CI, -2.71% to 2.25%; P =.83). Adverse skin reactions occurred more frequently in the negative pressure group vs the standard care group (7.0% vs 0.6%; difference, 6.95%; 95% CI, 1.86%-12.03%; P <.001).
The study was terminated after a planned interim analysis revealed increased frequency of adverse events in the negative pressure group and futility for the primary outcome. Study limitations included a significantly lower baseline risk for the primary outcome (3.4% vs 10% seen in previous studies), lack of adjustments made for multiple comparisons, and lack of treatment blinding, although data collection and patient records pertaining to infection and wound complications were reviewed blindly. The investigators report that the potential exists for significant differences in secondary end points, such as patient satisfaction scores at discharge.
The investigators conclude that, “among [women with obesity] undergoing cesarean delivery, prophylactic negative pressure wound therapy, compared with standard wound dressing, did not significantly reduce the risk of [SSI].” The study results therefore do not support the routine use of negative pressure therapy in this patient population after cesarean section.
Disclosure: Some of the study authors reported relationships that could represent a potential conflict of interest. Please refer to the original study for full disclosures.
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):1180-1189. doi:10.1001/jama.2020.13361