NCT05586776

Decolonization to Reduce After-Surgery Events of Surgical Site Infection

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,700 (estimated)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The DECREASE SSI Trial (Decolonization to Reduce After-Surgery Events of Surgical Site Infection) is a two-arm multi-center individual placebo-controlled randomized (2,700 participants randomized 1:1) clinical trial to reduce post-discharge surgical site infection following open colon or small bowel surgery by comparing chlorhexidine bathing plus nasal mupirocin in the 30 days following discharge to soap without antiseptic properties (placebo) and placebo nasal ointment. This trial seeks to enhance the care of the 675,000 patients annually who undergo colon and small bowel surgery by finding simple and efficacious interventions to reduce SSI.

Conditions

• Surgical Site Infection

Interventions

Type	Name	Description
DRUG	4% Chlorhexidine Gluconate	Used for daily showering/bathing for 30 days after hospital discharge.
DRUG	2% Mupirocin	Applied to each nostril twice daily for five days for the first two weeks after hospital discharge.
DRUG	Soap Without Antiseptic Properties (Placebo)	Used for daily showering/bathing for 30 days after hospital discharge.
DRUG	Placebo Nasal Ointment	Applied to each nostril twice daily for five days for the first two weeks after hospital discharge.

Timeline

• Start date: 2023-01-17
• Primary completion: 2027-01-01
• Completion: 2028-12-01
• First posted: 2022-10-19
• Last updated: 2025-07-28

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study