SUNRRISE
Trial question
What is the role of incisional negative pressure wound therapy for closed surgical wounds in patients undergoing emergency laparotomy?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
52.0% female
48.0% male
N = 821
821 patients (431 female, 390 male).
Inclusion criteria: adult patients undergoing emergency laparotomy.
Key exclusion criteria: abdominal surgical procedure within the previous months; plan to return for reopening of laparotomy wound within 30 days of surgical procedure; imminent death within 30 days.
Interventions
N=411 incisional negative pressure wound therapy (topical negative pressure dressing [PICO™ 7] providing -80 mmHg negative pressure across the wound).
N=410 surgeon's dressing preference (conventional occlusive dressings, skin glue, or no dressing).
Primary outcome
Rate of surgical site infection up to 30 days post-procedure
28.4%
27.4%
28.4 %
21.3 %
14.2 %
7.1 %
0.0 %
Incisional negative pressure wound
therapy
Surgeon's dressing
preference
No significant
difference ↔
No significant difference in the rate of surgical site infection up to 30 days post-procedure (28.4% vs. 27.4%; RR 1.03, 95% CI 0.83 to 1.28).
Secondary outcomes
No significant difference in mean 12-Item Short-Form health survey-physical component score at 30 days (9.8% vs. 10.2%; MD -0.86, 95% CI -2.83 to 1.11).
No significant difference in mean 12-Item Short-Form health survey-mental component score at 30 days (11.8% vs. 12%; MD -1.9, 95% CI -4.28 to 0.47).
No significant difference in mean pain at site of primary laparotomy at day 30 (1.5% vs. 1.6%; MD -0.06, 95% CI -0.28 to 0.16).
Safety outcomes
No significant differences in serious adverse events, death within 30 days.
Conclusion
In adult patients undergoing emergency laparotomy, incisional negative pressure wound therapy was not superior to surgeon's dressing preference with respect to the rate of surgical site infection up to 30 days post-procedure.
Reference
SUNRRISE Trial Study Group, Kristy Atherton, James Brown et al. Negative Pressure Dressings to Prevent Surgical Site Infection After Emergency Laparotomy: The SUNRRISE Randomized Clinical Trial. JAMA. 2025 Mar 11;333(10):853-863.
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