Surgical Site InfectionPhase 4DECREASE SSINCT05586776
Decolonization to Reduce After-Surgery Events of Surgical Site Infection
A Phase 4 study testing 4% Chlorhexidine Gluconate and 2% Mupirocin in people with Surgical Site Infection, run by University of California, Irvine at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- 4% Chlorhexidine Gluconate and 2% Mupirocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,700 participants
- Where
- 4 sitesUnited States
- Study dates
- 17 Jan 2023to Dec 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Infections requiring systemic antibacterial agents, so viral illness (e.g., COVID, flu) is not an exclusion.
- Topical antibacterial agents do not count toward exclusion (e.g., topical products for acne)
- Prophylactic antibacterial agents do not count toward exclusion
- Surgical incision not closed at discharge
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Philip Robinson, MD, 949-764-5752, philip.robinson@hoag.org
Philip Robinson, MD
- Recruiting
University of California, Irvine Medical Center
Orange, California, 92868
Susan Huang, MD, MPH, 9498245073, sshuang@hs.uci.edu
Susan Huang, MD, MPH
- Recruiting
University of California, Davis Medical Center
Sacramento, California, 95817
Stuart Cohen, MD, 916-734-3741, stcohen@ucdavis.edu
Stuart Cohen, MD
- Recruiting
University of California, San Francisco Medical Center
San Francisco, California, 94143
Deborah Yokoe, MD, MPH, 415-502-4165, deborah.yokoe@ucsf.edu
Deborah Yokoe, MD, MPH
About this study
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
- Being tested
- 4% Chlorhexidine Gluconate, 2% Mupirocin, Soap Without Antiseptic Properties (Placebo), Placebo Nasal Ointment
- Keywords
- Surgical Site Infection, SSI
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4% Chlorhexidine GluconateDrug
Used for daily showering/bathing for 30 days after hospital discharge.
2% MupirocinDrug
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 OintmentDrug
Applied to each nostril twice daily for five days for the first two weeks after hospital discharge.
| Study group | Role | What they receive |
|---|---|---|
| Decolonization | Active comparator | Participants randomized into this arm will perform decolonization using topical antiseptic soap (chlorhexidine body wash) and an antibiotic ointment (nasal mupirocin). Receives: 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. Receives: Drug: Soap Without Antiseptic Properties (Placebo); Drug: Placebo Nasal Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Post-Discharge Surgical Site Infection
Measured: Within 30 Days of Hospital Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start17 Jan 2023
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis, University of California, San Francisco, University of Massachusetts, Amherst, Hoag Memorial Hospital Presbyterian
- Responsible party
- Principal investigator, Susan Huang, University of California, Irvine
- Investigators
- Susan Huang, MD, MPH, Principal investigator, University of California, IrvineDeborah Yokoe, MD, MPH, Study director, University of California, San FranciscoStuart Cohen, MD, Study director, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586776
- Sponsor's protocol ID
- 1304
- Acronym
- DECREASE SSI
- Status last verified
- Jul 2026
- First submitted
- 15 Oct 2022
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.