Infectious Disease
Decolonization to Reduce After-Surgery Events of Surgical Site Infection (DECREASE SSI).
Infectious Diseases, including COVID TrialsWhat is the purpose of 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.
Eligibility
- 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
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Transfer to an acute care hospital
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Discharged to receive end-of-life hospice measures
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Discharged more than 14 days after surgery
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Allergic to mupirocin and/or chlorhexidine
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Active infection at enrollment*
*Refers to
- 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
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Surgical incision not closed at discharge
What is the full name of this Clinical Trial?
Decolonization to Reduce After-Surgery Events of Surgical Site Infection
- Principal InvestigatorPhilip Robinson, MD
- Age GroupAdult, Older Adult
- PhaseIV
- IRB NumberSTUDY05586776
- ClinicalTrials.gov IDNCT05586776
- Key Eligibilityclinicaltrials.gov
- How do I learn more about this study?Jake Doe
philip.robinson@hoag.org