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
- Are there results?
- Not yet: the study is under way
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
Show all 10Show fewer
- 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.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decolonization to Reduce After-Surgery Events of Surgical Site Infection
- ClinicalTrials.gov ID
- NCT05586776
- Acronym / sponsor ID
- DECREASE SSI / 1304
- Conditions
- Surgical Site Infection
- Keywords
- Surgical Site Infection, SSI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,700 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- University of California, Davis, University of California, San Francisco, University of Massachusetts, Amherst, Hoag Memorial Hospital Presbyterian
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decolonization | Active comparator | Drug: 4% Chlorhexidine Gluconate, Drug: 2% MupirocinParticipants randomized into this arm will perform decolonization using topical antiseptic soap (chlorhexidine body wash) and an antibiotic ointment (nasal mupirocin). |
| Routine Care | Placebo comparator | Drug: Soap Without Antiseptic Properties (Placebo), Drug: Placebo Nasal OintmentParticipants randomized into this arm will perform routine care using soap without antiseptic properties (placebo) and placebo nasal ointment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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*
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4% Chlorhexidine GluconateUsed for daily showering/bathing for 30 days after hospital discharge. | Drug | Decolonization |
| 2% MupirocinApplied to each nostril twice daily for five days for the first two weeks after hospital discharge. | Drug | Decolonization |
| Soap Without Antiseptic Properties (Placebo)Used for daily showering/bathing for 30 days after hospital discharge. | Drug | Routine Care |
| Placebo Nasal OintmentApplied to each nostril twice daily for five days for the first two weeks after hospital discharge. | Drug | Routine Care |
Primary outcome
Time to First Post-Discharge Surgical Site Infection
Time frame: Within 30 Days of Hospital Discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susan Huang, MD, MPH principal investigator
University of California, Irvine
Deborah Yokoe, MD, MPH study director
University of California, San Francisco
Stuart Cohen, MD study director
University of California, Davis
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susan Huang, MD, MPH ((949) 824-5073, sshuang@hs.uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Post-Discharge Surgical Site Infection (time frame: Within 30 Days of Hospital Discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.