Decolonization to Reduce After-Surgery Events of Surgical Site Infection
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Enrollment
- 2,700
- Locations
- 8
- Primary Endpoint
- Time to First Post-Discharge Surgical Site Infection
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 ≥
- •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
Arms & Interventions
Decolonization
Participants randomized into this arm will perform decolonization using topical antiseptic soap (chlorhexidine body wash) and an antibiotic ointment (nasal mupirocin).
Intervention: 2% Mupirocin (Drug)
Routine Care
Participants randomized into this arm will perform routine care using soap without antiseptic properties (placebo) and placebo nasal ointment.
Intervention: Soap Without Antiseptic Properties (Placebo) (Drug)
Routine Care
Participants randomized into this arm will perform routine care using soap without antiseptic properties (placebo) and placebo nasal ointment.
Intervention: Placebo Nasal Ointment (Drug)
Decolonization
Participants randomized into this arm will perform decolonization using topical antiseptic soap (chlorhexidine body wash) and an antibiotic ointment (nasal mupirocin).
Intervention: 4% Chlorhexidine Gluconate (Drug)
Outcomes
Primary Outcomes
Time to First Post-Discharge Surgical Site Infection
Time Frame: Within 30 Days of Hospital Discharge
Secondary Outcomes
No secondary outcomes reported
Investigators
Susan Huang
Professor, Division of Infectious Diseases and Medical Director, Epidemiology and Infection Prevention
University of California, Irvine