Decolonization to Reduce After-Surgery Events of Surgical Site Infection (DECREASE SSI)

University of California, Davis, University of California, San Francisco, University of Massachusetts, Amherst

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.

Participants randomized into this arm will perform decolonization using topical antiseptic soap (chlorhexidine body wash) and an antibiotic ointment (nasal mupirocin).

Participants randomized into this arm will perform routine care using soap without antiseptic properties (placebo) and placebo nasal ointment.

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 Infections requiring systemic antibacterial agents, so viral illness (e.g., COVID, flu) is not an exclusion. Topical antibacterial agents do not count toward exclusion (e.g., topical products for acne) Prophylactic antibacterial agents do not count toward exclusion Surgical incision not closed at discharge

A data request form will be provided to any researcher requesting data from the DECREASE SSI trial This data request form will request the hypothesis/goal of the research, the planned use of the data, and the requested data elements (deidentified only). Any data provided will include the stipulation that use is limited to research purposes only. Requests will not be granted for pursuits directly specified in the grant. If the data request overlaps with additional ongoing post-grant pursuits either by this team or another investigative team that requested the data for a given purpose, a discussion will be pursued toward the potential for joint collaboration.