Decolonization to Reduce After-Surgery Events of Surgical Site Infection
NCT ID: NCT05586776
Last Updated: 2025-07-28
Study Results
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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RECRUITING
PHASE4
2700 participants
INTERVENTIONAL
2023-01-17
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
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).
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.
Routine Care
Participants randomized into this arm will perform routine care using soap without antiseptic properties (placebo) and placebo nasal ointment.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of California, Davis
OTHER
University of California, San Francisco
OTHER
University of Massachusetts, Amherst
OTHER
Hoag Memorial Hospital Presbyterian
OTHER
University of California, Irvine
OTHER
Responsible Party
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Susan Huang
Professor, Division of Infectious Diseases and Medical Director, Epidemiology and Infection Prevention
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
University of California, Irvine Medical Center
Orange, California, United States
University of California, Davis Medical Center
Sacramento, California, United States
University of California, San Francisco Medical Center
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1304
Identifier Type: -
Identifier Source: org_study_id
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