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

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 Overview

• Status: Recruiting
• Conditions: Surgical Site Infection
• Intervention / Treatment: Drug: 4% Chlorhexidine Gluconate; Drug: 2% Mupirocin; Drug: Soap Without Antiseptic Properties (Placebo); Drug: Placebo Nasal Ointment

• Study Type: Interventional
• Enrollment (Estimated): 2700
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Susan Huang, MD, MPH; Phone Number: (949) 824-5073; Email: sshuang@hs.uci.edu
• Study Contact Backup: Name: Raveena Singh, MA; Phone Number: (949) 824-9285; Email: ravsingh@hs.uci.edu

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92663
      • Recruiting
      • Hoag Memorial Hospital Presbyterian
      • Principal Investigator: Philip Robinson, MD
      • Contact: Philip Robinson, MD; Phone Number: 949-764-5752; Email: philip.robinson@hoag.org
    • Orange, California, United States, 92868
      • Recruiting
      • University of California, Irvine Medical Center
      • Principal Investigator: Susan Huang, MD, MPH
      • Contact: Susan Huang, MD, MPH; Phone Number: 9498245073; Email: sshuang@hs.uci.edu
    • Sacramento, California, United States, 95817
      • Recruiting
      • University of California, Davis Medical Center
      • Principal Investigator: Stuart Cohen, MD
      • Contact: Stuart Cohen, MD; Phone Number: 916-734-3741; Email: stcohen@ucdavis.edu
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California, San Francisco Medical Center
      • Contact: Deborah Yokoe, MD, MPH; Phone Number: 415-502-4165; Email: deborah.yokoe@ucsf.edu
      • Principal Investigator: Deborah Yokoe, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Decolonization; Participants randomized into this arm will perform decolonization using topical antiseptic soap (chlorhexidine body wash) and an antibiotic ointment (nasal mupirocin).	Drug: 4% Chlorhexidine Gluconate; Used for daily showering/bathing for 30 days after hospital discharge.; Drug: 2% Mupirocin; Applied to each nostril twice daily for five days for the first two weeks after hospital discharge.
Placebo Comparator: Routine Care; Participants randomized into this arm will perform routine care using soap without antiseptic properties (placebo) and placebo nasal ointment.	Drug: Soap Without Antiseptic Properties (Placebo); Used for daily showering/bathing for 30 days after hospital discharge.; Drug: Placebo Nasal Ointment; Applied to each nostril twice daily for five days for the first two weeks after hospital discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to First Post-Discharge Surgical Site Infection	Within 30 Days of Hospital Discharge

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Collaborators: University of California, Davis; University of California, San Francisco; Hoag Memorial Hospital Presbyterian; University of Massachusetts, Amherst
• Investigators: Study Director: Deborah Yokoe, MD, MPH, University of California, San Francisco; Study Director: Stuart Cohen, MD, University of California, Davis; Principal Investigator: Susan Huang, MD, MPH, University of California, Irvine

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: October 15, 2022
• First Submitted That Met QC Criteria: October 15, 2022
• First Posted (Actual): October 19, 2022

Study Record Updates

• Last Update Posted (Actual): July 28, 2025
• Last Update Submitted That Met QC Criteria: July 23, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Surgical Site Infection; SSI
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Disease Attributes; Wound Infection; Infections; Communicable Diseases; Surgical Wound Infection; Anti-Bacterial Agents; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Dermatologic Agents; Protein Synthesis Inhibitors; Disinfectants; Chlorhexidine; Anti-Infective Agents, Local; Chlorhexidine gluconate; Mupirocin
• Other Study ID Numbers: 1304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 3 years from publication
• IPD Sharing Access Criteria: Pending
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes