Decolonization to Reduce After-Surgery Events of Surgical Site Infection

NCT ID: NCT05586776

Last Updated: 2025-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

2700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-17

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Surgical Site Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Decolonization

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

Group Type ACTIVE_COMPARATOR

4% Chlorhexidine Gluconate

Intervention Type DRUG

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

2% Mupirocin

Intervention Type DRUG

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

Routine Care

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

Group Type PLACEBO_COMPARATOR

Soap Without Antiseptic Properties (Placebo)

Intervention Type DRUG

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

Placebo Nasal Ointment

Intervention Type DRUG

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

Interventions

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4% Chlorhexidine Gluconate

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

Intervention Type DRUG

2% Mupirocin

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

Intervention Type DRUG

Soap Without Antiseptic Properties (Placebo)

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

Intervention Type DRUG

Placebo Nasal Ointment

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Davis

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role collaborator

University of Massachusetts, Amherst

OTHER

Sponsor Role collaborator

Hoag Memorial Hospital Presbyterian

OTHER

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Susan Huang

Professor, Division of Infectious Diseases and Medical Director, Epidemiology and Infection Prevention

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susan Huang, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Deborah Yokoe, MD, MPH

Role: STUDY_DIRECTOR

University of California, San Francisco

Stuart Cohen, MD

Role: STUDY_DIRECTOR

University of California, Davis

Locations

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Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Site Status RECRUITING

University of California, Irvine Medical Center

Orange, California, United States

Site Status RECRUITING

University of California, Davis Medical Center

Sacramento, California, United States

Site Status RECRUITING

University of California, San Francisco Medical Center

San Francisco, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Susan Huang, MD, MPH

Role: CONTACT

(949) 824-5073

Raveena Singh, MA

Role: CONTACT

(949) 824-9285

Facility Contacts

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Philip Robinson, MD

Role: primary

949-764-5752

Susan Huang, MD, MPH

Role: primary

9498245073

Stuart Cohen, MD

Role: primary

916-734-3741

Deborah Yokoe, MD, MPH

Role: primary

415-502-4165

Other Identifiers

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1304

Identifier Type: -

Identifier Source: org_study_id

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