NCT05586776 Decolonization to Reduce After-Surgery Events of Surgical Site Infection
| NCT ID | NCT05586776 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of California, Irvine |
| Condition | Surgical Site Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,700 participants |
| Start Date | 2023-01-17 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 2,700 participants in total. It began in 2023-01-17 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Susan Huang, MD, MPH
PRINCIPAL INVESTIGATOR
University of California, Irvine
Frequently Asked Questions
Who can join the NCT05586776 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Surgical Site Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05586776 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05586776 currently recruiting?
Yes, NCT05586776 is actively recruiting participants. Contact the research team at sshuang@hs.uci.edu for enrollment information.
Where is the NCT05586776 trial being conducted?
This trial is being conducted at Newport Beach, United States, Orange, United States, Sacramento, United States, San Francisco, United States.
Who is sponsoring the NCT05586776 clinical trial?
NCT05586776 is sponsored by University of California, Irvine. The principal investigator is Susan Huang, MD, MPH at University of California, Irvine. The trial plans to enroll 2,700 participants.