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Decolonization to Reduce After-Surgery Events of Surgical Site Infection (DECREASE SSI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05586776
Recruitment Status : Recruiting
First Posted : October 19, 2022
Last Update Posted : August 14, 2023
Sponsor:
Collaborators:
University of California, Davis
University of California, San Francisco
University of Massachusetts, Amherst
Information provided by (Responsible Party):
Susan Huang, University of California, Irvine

Study Description
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Brief 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 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.

Condition or disease Intervention/treatment Phase
Surgical Site Infection Drug: 4% Chlorhexidine Gluconate Drug: 2% Mupirocin Drug: Soap Without Antiseptic Properties (Placebo) Drug: Placebo Nasal Ointment Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Decolonization to Reduce After-Surgery Events of Surgical Site Infection
Actual Study Start Date : January 17, 2023
Estimated Primary Completion Date : December 2027
Estimated Study Completion Date : December 2028
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Decolonization
Participants randomized into this arm will perform decolonization using topical antiseptic soap (chlorhexidine body wash) and an antibiotic ointment (nasal mupirocin).
 Drug: 4% Chlorhexidine Gluconate
Used for daily showering/bathing for 30 days after hospital discharge.

Drug: 2% Mupirocin
Applied to each nostril twice daily for five days for the first two weeks after hospital discharge.
Placebo Comparator: Routine Care
Participants randomized into this arm will perform routine care using soap without antiseptic properties (placebo) and placebo nasal ointment.
 Drug: Soap Without Antiseptic Properties (Placebo)
Used for daily showering/bathing for 30 days after hospital discharge.

Drug: Placebo Nasal Ointment
Applied to each nostril twice daily for five days for the first two weeks after hospital discharge.


Outcome Measures
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Primary Outcome Measures :
  1. Time to First Post-Discharge Surgical Site Infection [ Time Frame: Within 30 Days of Hospital Discharge ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05586776


Contacts
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Contact: Susan Huang, MD, MPH (949) 824-5073 sshuang@hs.uci.edu
Contact: Raveena Singh, MA (949) 824-9285 ravsingh@hs.uci.edu

Locations
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United States, California
University of California, Irvine Medical Center Recruiting
Orange, California, United States, 92868
Contact: Susan Huang, MD, MPH    949-824-5073    sshuang@hs.uci.edu   
Principal Investigator: Susan Huang, MD, MPH         
University of California, Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Stuart Cohen, MD    916-734-3741    stcohen@ucdavis.edu   
Principal Investigator: Stuart Cohen, MD         
University of California, San Francisco Medical Center Recruiting
San Francisco, California, United States, 94143
Contact: Deborah Yokoe, MD, MPH    415-502-4165    deborah.yokoe@ucsf.edu   
Principal Investigator: Deborah Yokoe, MD, MPH         
Sponsors and Collaborators
University of California, Irvine
University of California, Davis
University of California, San Francisco
University of Massachusetts, Amherst
Investigators
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Principal Investigator: Susan Huang, MD, MPH University of California, Irvine
Study Director: Deborah Yokoe, MD, MPH University of California, San Francisco
Study Director: Stuart Cohen, MD University of California, Davis
More Information
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Responsible Party: Susan Huang, Professor, Division of Infectious Diseases and Medical Director, Epidemiology and Infection Prevention, University of California, Irvine
ClinicalTrials.gov Identifier: NCT05586776    
Other Study ID Numbers: 1304
First Posted: October 19, 2022    Key Record Dates
Last Update Posted: August 14, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: 3 years from publication
Access Criteria: Pending

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Susan Huang, University of California, Irvine:
Surgical Site Infection
SSI
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Surgical Wound Infection
Disease Attributes
Pathologic Processes
Wound Infection
Postoperative Complications
Chlorhexidine
Chlorhexidine gluconate
 Anti-Infective Agents, Local
Mupirocin
Anti-Infective Agents
Disinfectants
Dermatologic Agents
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action