Effect of standard wound dressing versus prophylactic closed incision negative-pressure therapy on surgical-site infection after open incisional hernia repair: multicentre randomized clinical trial

Abstract Background The benefit of closed incision negative-pressure therapy (ciNPT) after open incisional hernia repair in reducing surgical-site infection (SSI) is uncertain. Methods The PROPRESS multicentre RCT was conducted from 1 March 2023 to 25 June 2024 at three Danish hospitals. Patients undergoing elective open incisional hernia repair were randomized to ciNPT or a standard wound dressing (SWD). The primary outcome was the incidence of SSI at 30 days. Secondary outcomes at 30 days included the pooled incidence of surgical-site occurrences (SSOs), patient-reported quality of life (QoL), and patient-reported scar assessment. The last follow-up date was 25 July 2024. Results A total of 110 patients were randomized (54 SWD patients and 56 ciNPT patients; median age of 63.9 (interquartile range 50.7–69.0) years; 45 (40.1%) were female) and 108 (98.2%) completed follow-up at 30 days. In total, 7 of the 110 patients (6.4%) were smokers, the mean(s.d.) BMI was 29.3(4.1) kg/m2, and the mean(s.d.) horizontal defect size was 8.7(4.7) cm. One death in each group was unrelated to the intervention, but surgery and anaesthesia may have been predisposing factors for mortality. There was no difference in SSI rates; 4 of 53 patients (8%) in the SWD group versus 7 of 55 patients (13%) in the ciNPT group (P = 0.673). With regard to SSOs, these affected 12 of 53 patients (23%) in the SWD group versus 14 of 55 patients (26%) in the ciNPT group (P = 0.907). There was no difference in scar scores (equal mean scores of 24; P = 0.892) and overall QoL improved significantly (mean score difference: −12.8 (95% c.i. −15.4 to −10.2); P < 0.001) without a difference between the groups (mean score change: SWD −12.6 versus ciNPT −13.0; P = 0.874). Conclusion ciNPT did not reduce SSI after open incisional hernia repair in this RCT, which was limited by the relatively small number of patients. Registration number NCT05050786 (http://www.clinicaltrials.gov).