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NCT05586776PHASE4Recruiting

Decolonization to Reduce After-Surgery Events of Surgical Site Infection

University of California, Irvine

Start Date

1/17/2023

Completion Date

12/1/2027

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

Age Range: 18 years to No maximum

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

Interventions

DRUG

4% Chlorhexidine Gluconate

DRUG

2% Mupirocin

DRUG

Soap Without Antiseptic Properties (Placebo)

DRUG

Placebo Nasal Ointment

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Conditions

Surgical Site Infection

Locations

Hoag Memorial Hospital Presbyterian

Newport Beach, California 92663

United States

University of California, Irvine Medical Center

Orange, California 92868

United States

University of California, Davis Medical Center

Sacramento, California 95817

United States

University of California, San Francisco Medical Center

San Francisco, California 94143

United States