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Recruiting NCT05586776

Decolonization to Reduce After-Surgery Events of Surgical Site Infection

Conditions: Surgical Site Infection

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 2700
Sponsor: University of California, Irvine

Location: Hoag Memorial Hospital Presbyterian Newport Beach California

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.

Eligibility 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05586776). StuddyBuddy aggregates publicly available trial information.