Reducing surgical site infections after colon or small bowel surgery
Decolonization to Reduce After-Surgery Events of Surgical Site Infection
This study is testing whether using special washes and ointments can help prevent infections after colon or small bowel surgery for patients who have just been discharged from the hospital.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 2700 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Irvine Academic / other |
| Locations | 4 sites (Newport Beach, California and 3 other locations) |
| Trial ID | NCT05586776 on ClinicalTrials.gov |
What this trial studies
The DECREASE SSI Trial aims to reduce post-discharge surgical site infections (SSIs) in patients who have undergone open colon or small bowel surgery. This multi-center, randomized clinical trial will compare the effectiveness of chlorhexidine bathing and nasal mupirocin against a placebo treatment over a 30-day period following discharge. With 2,700 participants, the study seeks to identify simple and effective interventions to enhance patient care and outcomes for the 675,000 patients who undergo these surgeries annually.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have had recent open abdominal surgery within the past 14 days.
Not a fit: Patients who are allergic to mupirocin or chlorhexidine, or those with active infections at enrollment, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly lower the incidence of surgical site infections, improving recovery and reducing healthcare costs for patients.
How similar studies have performed: Previous studies have shown promising results with similar decolonization approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years of age or older * Recent open (not solely laparoscopic) surgery involving an abdominal incision within the past 14 days. For cesarean section, recruitment restricted to BMI ≥ 40. * 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\* \*Refers to 1. Infections requiring systemic antibacterial agents, so viral illness (e.g., COVID, flu) is not an exclusion. 2. Topical antibacterial agents do not count toward exclusion (e.g., topical products for acne) 3. Prophylactic antibacterial agents do not count toward exclusion * Surgical incision not closed at discharge
Where this trial is running
Newport Beach, California and 3 other locations
- Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States (Recruiting)
- University of California, Irvine Medical Center — Orange, California, United States (Recruiting)
- University of California, Davis Medical Center — Sacramento, California, United States (Recruiting)
- University of California, San Francisco Medical Center — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Susan Huang, MD, MPH — University of California, Irvine
- Study coordinator: Susan Huang, MD, MPH
- Email: sshuang@hs.uci.edu
- Phone: (949) 824-5073
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.