Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID05586776

Decolonization to Reduce After-Surgery Events of Surgical Site Infection

Led by University of California, Irvine · Updated on 2025-07-28

2700

Participants Needed

4

Research Sites

100 weeks

Total Duration

On this page

Sponsors

U

University of California, Irvine

Lead Sponsor

U

University of California, Davis

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a method to reduce infections at the site of surgery after discharge in patients who have undergone open colon or small bowel surgery. This study, called the DECREASE SSI Trial, is a Phase 4 randomized clinical trial involving 2,700 participants. It compares the effects of using chlorhexidine body wash plus nasal mupirocin ointment versus regular soap and placebo nasal ointment to lower surgical site infections (SSI) occurring within 30 days after hospital discharge. Participants are randomly assigned to one of two groups. One group uses 4% chlorhexidine gluconate for daily bathing for 30 days after leaving the hospital and applies 2% mupirocin ointment to each nostril twice daily for five days during the first two weeks after discharge. The other group follows routine care using soap without antiseptic properties for bathing and placebo nasal ointment with the same schedule. This comparison aims to find simple, effective ways to reduce SSI in the large population undergoing these surgeries each year. During the study, participants will be monitored for the time until they experience a surgical site infection after discharge, within a 30-day period. Researchers will track adherence to the bathing and ointment application protocols and collect data on any infections that develop. Safety and outcomes will be followed closely throughout the 30 days post-discharge to evaluate the effectiveness of the interventions in preventing infections and improving post-surgical recovery.

CONDITIONS

Brief Title

Decolonization to Reduce After-Surgery Events of Surgical Site Infection

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Recent open (not solely laparoscopic) abdominal surgery within the past 14 days
  • For cesarean section, body mass index (BMI) of 40 or higher
  • Able to communicate regularly by phone
  • Able to bathe, shower, or have this done by a caregiver
Not Eligible

You will not qualify if you...

  • Transfer to an acute care hospital
  • Discharged to receive end-of-life hospice care
  • Surgery discharge more than 14 days ago
  • Allergy to mupirocin or chlorhexidine
  • Active infection requiring systemic antibacterial agents at enrollment
  • Surgical incision not closed at discharge

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - Up to 14 days after surgery

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 30 days after hospital discharge

Participants use topical antiseptic soap or placebo and apply nasal ointment or placebo for decolonization to reduce surgical site infections after hospital discharge.

Daily showering/bathing and nasal ointment applied twice daily for 5 days during the first two weeks

Trial Site Locations

Total: 4 locations

1

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States, 92663

Actively Recruiting

2

University of California, Irvine Medical Center

Orange, California, United States, 92868

Actively Recruiting

3

University of California, Davis Medical Center

Sacramento, California, United States, 95817

Actively Recruiting

4

University of California, San Francisco Medical Center

San Francisco, California, United States, 94143

Actively Recruiting

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Research Team

S

Susan Huang, MD, MPH

R

Raveena Singh, MA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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