Recruiting

Decolonization

Sponsor:

UCLA

Code:

NCT05586776

Conditions

Surgical Site Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

4% Chlorhexidine Gluconate

2% Mupirocin

Soap Without Antiseptic Properties (Placebo)

Placebo Nasal Ointment

Study Details

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.

Conditions

Surgical Site Infection

Study ID

NCT05586776

Start date

Jan 17, 2023

Status verified date

Jul, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

2700 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Decolonization

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

placebo comparator: Routine Care

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

Interventions

4% Chlorhexidine Gluconate

Used for daily showering/bathing for 30 days after hospital discharge.

2% Mupirocin

Applied to each nostril twice daily for five days for the first two weeks after hospital discharge.

Soap Without Antiseptic Properties (Placebo)

Used for daily showering/bathing for 30 days after hospital discharge.

Placebo Nasal Ointment

Applied to each nostril twice daily for five days for the first two weeks after hospital discharge.

Primary outcome measure

  • Time to First Post-Discharge Surgical Site Infection [ Time Frame: Within 30 Days of Hospital Discharge ]

Central Contacts and Locations

Central contacts

Susan Huang, MD, MPH

(949) 824-5073sshuang@hs.uci.edu

Raveena Singh, MA

(949) 824-9285ravsingh@hs.uci.edu

Locations

Hoag Memorial Hospital Presbyterian

Recruiting

Newport Beach, California, United States, 92663

Contacts

Philip Robinson, MD

949-764-5752philip.robinson@hoag.org

Principal Investigator:

Philip Robinson, MD

University of California, Irvine Medical Center

Recruiting

Orange, California, United States, 92868

Contacts

Susan Huang, MD, MPH

9498245073sshuang@hs.uci.edu

Principal Investigator:

Susan Huang, MD, MPH

University of California, Davis Medical Center

Recruiting

Sacramento, California, United States, 95817

Contacts

Stuart Cohen, MD

916-734-3741stcohen@ucdavis.edu

Principal Investigator:

Stuart Cohen, MD

University of California, San Francisco Medical Center

Recruiting

San Francisco, California, United States, 94143

Contacts

Deborah Yokoe, MD, MPH

415-502-4165deborah.yokoe@ucsf.edu

Principal Investigator:

Deborah Yokoe, MD, MPH

More Information

Sponsor

University of California, Irvine

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Keywords

  • Surgical Site Infection
  • SSI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2026-07-21.