Decolonization to Reduce After-Surgery Events of Surgical Site Infection

Part of paid clinical trials in Newport Beach, California.

Sponsor
University of California, Irvine
Study ID
NCT05586776
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Surgical Site Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 4% Chlorhexidine Gluconate — DRUG
    Used for daily showering/bathing for 30 days after hospital discharge.
  • 2% Mupirocin — DRUG
    Applied to each nostril twice daily for five days for the first two weeks after hospital discharge.
  • Soap Without Antiseptic Properties (Placebo) — DRUG
    Used for daily showering/bathing for 30 days after hospital discharge.
  • Placebo Nasal Ointment — DRUG
    Applied to each nostril twice daily for five days for the first two weeks after hospital discharge.

Study Details

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.

Key Dates

Start date
Jan 17, 2023
Status verified
Jul 2025
Primary completion
Jan 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
2,700 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

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

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Hoag Memorial Hospital PresbyterianNewport BeachCalifornia92663
Philip Robinson, MD
[email protected]
949-764-5752
Philip Robinson, MD (PRINCIPAL_INVESTIGATOR)
University of California, Irvine Medical CenterOrangeCalifornia92868
Susan Huang, MD, MPH
[email protected]
9498245073
Susan Huang, MD, MPH (PRINCIPAL_INVESTIGATOR)
University of California, Davis Medical CenterSacramentoCalifornia95817
Stuart Cohen, MD
[email protected]
916-734-3741
Stuart Cohen, MD (PRINCIPAL_INVESTIGATOR)
University of California, San Francisco Medical CenterSan FranciscoCalifornia94143
Deborah Yokoe, MD, MPH
[email protected]
415-502-4165
Deborah Yokoe, MD, MPH (PRINCIPAL_INVESTIGATOR)

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Hoag Memorial Hospital Presbyterian· Newport Beach, CAUniversity of California, Irvine Medical Center· Orange, CAUniversity of California, Davis Medical Center· Sacramento, CAUniversity of California, San Francisco Medical Center· San Francisco, CA

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