For a study, researchers wanted to determine the efficacy of preventive negative pressure wound treatment in patients having laparotomy for gynecologic surgery. Researchers carried out a randomized controlled experiment. Eligible, consenting patients, regardless of BMI, having laparotomy for probable gynecologic cancer were randomly assigned to conventional gauze or negative pressure wound care. Patients with BMIs of 40 or higher who had the benign disease were also eligible. Following skin closure, participants were randomly assigned to groups based on their BMI. The main result was wound complication within 30 days following surgery. A sample size of 343 (N=686) was intended for each group.
They identified 663 prospective patients between March 1, 2016, and August 20, 2019; 289 were randomized to negative pressure wound care (254 evaluable participants) and 294 to conventional gauze (251 evaluable participants), for a total of 505 evaluable patients. The overall cohort’s median age was 61 years (range 20–87). Four hundred ninety-five patients (98%) had laparotomies for cancer. After an interim review of 444 patients, the experiment was finally halted for futility. The rate of wound complications was 17.3% in the NPWT group and 16.3% in the gauze group, with an absolute risk difference of 1% (90% CI 4.5 to 6.5%; P=.77). The adjusted odds ratio (90% CI 0.62–1.60) after adjusting for expected blood loss and diabetes was 0.99. In the NPWT group, skin blistering occurred in 33 patients (13%), while it happened in three patients (1.2%) in the gauze group (P<.001).
After a laparotomy for gynecologic surgery, negative pressure wound care did not reduce wound complications, although it did increase skin blistering.