Decolonization to Reduce After-Surgery Events of Surgical Site Infection

NCT05586776 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 1304
• Study Type: interventional
• Target: 2,700
• Locations: 1 country
• Sites: 4

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

Keywords

Surgical Site Infection; SSI

Outcome Measures

Primary Outcomes (1)

• Time to First Post-Discharge Surgical Site Infection

  Within 30 Days of Hospital Discharge

Study Arms (2)

Decolonization

ACTIVE COMPARATOR

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; Drug: 2% Mupirocin

Routine Care

PLACEBO COMPARATOR

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); Drug: Placebo Nasal Ointment

Interventions

4% Chlorhexidine Gluconate DRUG

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

Decolonization

2% Mupirocin DRUG

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

Decolonization

Soap Without Antiseptic Properties (Placebo) DRUG

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

Routine Care

Placebo Nasal Ointment DRUG

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

Routine Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Surgical incision not closed at discharge

Sponsors & Collaborators

• University of California, Irvine: lead
• University of California, Davis: collaborator
• University of California, San Francisco: collaborator
• University of Massachusetts, Amherst: collaborator
• Hoag Memorial Hospital Presbyterian: collaborator

Study Sites (4)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

RECRUITING

University of California, Irvine Medical Center

Orange, California, 92868, United States

RECRUITING

University of California, Davis Medical Center

Sacramento, California, 95817, United States

RECRUITING

University of California, San Francisco Medical Center

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

chlorhexidine gluconate; Mupirocin; Soaps

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epoxy Compounds; Ethers, Cyclic; Ethers; Organic Chemicals; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids; Detergents; Surface-Active Agents; Specialty Uses of Chemicals; Chemical Actions and Uses; Household Products; Technology, Industry, and Agriculture

Study Officials

• Susan Huang, MD, MPH

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

• Deborah Yokoe, MD, MPH

  University of California, San Francisco

  STUDY DIRECTOR

• Stuart Cohen, MD

  University of California, Davis

  STUDY DIRECTOR

Central Study Contacts

Susan Huang, MD, MPH

CONTACT

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

Raveena Singh, MA

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Division of Infectious Diseases and Medical Director, Epidemiology and Infection Prevention

Study Record Dates

• First Submitted: October 15, 2022
• First Posted: October 19, 2022
• Study Start: January 17, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 3 years from publication
• Access Criteria: Pending

Locations

US (4)