RecruitingPhase 4NCT05586776

Decolonization to Reduce After-Surgery Events of Surgical Site Infection

Sponsor

University of California, Irvine

Enrollment

2,700 participants

Start Date

Jan 17, 2023

Study Type

INTERVENTIONAL

Conditions

Surgical Site Infection

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

Min Age: 18 Years

Inclusion Criteria4

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 Criteria10

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