Decolonization to Reduce After-Surgery Events of Surgical Site Infection

• Status: Not yet recruiting
• Trial end date: 2028-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Irvine
• Collaborators: University of California, Davis; University of California, San Francisco; University of Massachusetts, Amherst
• Treatments: Anti-Infective Agents, Local; Chlorhexidine; Chlorhexidine gluconate; Mupirocin

Criteria

Inclusion Criteria:

• 18 years of age or older

• Recent surgery that involves the colon or small bowel using an open (non-laparoscopic) approach within the past 14 days

• Able to communicate regularly by phone

• Able to bathe, shower or have this task performed by a caregiver

Exclusion Criteria:

• Transfer to an acute care hospital

• Discharged to receive end-of-life hospice measures

• Discharged more than 14 days after surgery

• Allergic to mupirocin and/or chlorhexidine

• Active infection at enrollment