NCT05586776 · University of California, Irvine
Decolonization to Reduce After-Surgery Events of Surgical Site Infection
(DECREASE SSI)
What this study is about
The DECREASE SSI Trial (Decolonization to Reduce After-Surgery Events of Surgical Site Infection) is a two-treatment group$1 multi-center individual compared against an inactive treatment randomly assigned (2,700 participants randomly assigned 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 enha
View original scientific description
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.
Interventions
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.
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.
Primary outcome measures
Time to First Post-Discharge Surgical Site Infection
Time frame: Within 30 Days of Hospital Discharge
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Newport Beach, California
- Orange, California
- Sacramento, California
- San Francisco, California
Collaborators
University of California, Davis, University of California, San Francisco, University of Massachusetts, Amherst, Hoag Memorial Hospital Presbyterian
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 28, 2025 · Source of record for eligibility and locations