Negative Pressure Dressings to Prevent Surgical Site Infection After Emergency Laparotomy: The SUNRRISE Randomized Clinical Trial

Abstract

Importance: Patients undergoing unplanned abdominal surgical procedures are at increased risk of surgical site infection (SSI). It is not known if incisional negative pressure wound therapy (iNPWT) can reduce SSI rates in this setting.

Objective: To evaluate the effectiveness of iNPWT in reducing the rate of SSI in adults undergoing emergency laparotomy with primary skin closure.

Design, setting, and participants: SUNRRISE was an assessor-masked, pragmatic, phase 3, individual-participant, randomized clinical trial. Adult patients undergoing emergency laparotomy in 22 hospitals in the UK and 12 hospitals in Australia between December 18, 2018, and May 25, 2021, were recruited. Patients were followed up for 30 days postprocedure; database closure was on August 25, 2021.

Interventions: Participants were randomized 1:1 to receive iNPWT (n = 411), which involved a specialized dressing used to create negative pressure over the closed wound vs the surgeon's choice of wound dressing (n = 410). Randomization and dressing application occurred in the operating room at the end of the surgical procedure.

Main outcomes and measures: The primary outcome measure was SSI up to 30 days postprocedure, evaluated by an assessor masked to the randomized allocation and using criteria from the US Centers for Disease Control and Prevention. There were 7 secondary outcomes, including length of hospital stay, postoperative complications up to 30 days, hospital readmission for wound-related complications within 30 days, wound pain, and quality of life.

Results: A total of 840 patients were randomized (536 from the UK; 304 from Australia). Overall, 52% were female; the mean age was 63.8 (range, 18.8 to 95.3) years. After postrandomization exclusions (N = 52), 394 participants per group were included in the primary analysis. The number of participants who had an SSI in the iNPWT group was 112 of 394 (28.4%), compared with 108 of 394 (27.4%) in the surgeon's preference group (relative risk, 1.03 [95% CI, 0.83-1.28]; P = .78). This finding was consistent across the preplanned subgroup analyses, including degree of contamination, presence of a stoma, participant body mass index, and skin preparation used, and across all preplanned sensitivity analyses. Of 7 secondary outcomes, 6 showed no significant difference, including hospital readmission, quality of life, and hospital stay (median [IQR], 8 [6-14] days in the iNPWT group and 9 [6-14.5] days in the surgeon's preference group [ratio of geometric means, 0.96 (95% CI, 0.88-1.06); P = .21]).

Conclusions and relevance: Routine application of iNPWT to the closed surgical wound after emergency laparotomy did not prevent SSI more than other dressings.

Trial registration: isrctn.com Identifier: ISRCTN17599457; anzctr.org.au Identifier: ACTRN12619000496112.

Figure 1.. Recruitment, Randomization, and Follow-Up in the SUNRRISE Trial

iNPWT indicates incisional negative pressure wound therapy. ^aReasons for ineligibility were abdominal operation within the preceding 3 months of randomization (286), long-term incapacity or unable to provide informed consent (114), procedure not an emergency laparotomy (100), expected to return for reopening of the laparotomy wound within 30 days (56), unwilling or unable to attend follow-up at 30 days (49), incision of less than 5 cm (47), skin not primarily closed (26), personal consultee or legal representative unavailable (22), and younger than 16 years (9). ^bA total of 25 deaths were reported (10 in the iNPWT group and 15 in the surgeon’s preference group), of which 12 participants (5 in the iNPWT group and 7 in the surgeon’s preference group) provided primary outcome data prior to death and therefore were included in the primary analysis. ^cDespite completing the day 30 follow-up, patients were missing data for US Centers for Disease Control and Prevention criteria, which resulted in the primary outcome not being computed.

Figure 2.. Subgroup Analysis

BMI indicates body mass index (calculated as weight in kilograms divided by height in meters squared); iNPWT, incisional negative pressure wound therapy; and SSI, surgical site infection. ^aUK-based patients only.