Decolonization to Reduce After-Surgery Events of Surgical Site Infection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 4% Chlorhexidine Gluconate, 2% Mupirocin, Soap Without Antiseptic Properties (Placebo), Placebo Nasal Ointment.
- Who it may be relevant to
- Registry conditions: Surgical Site Infection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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]
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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
United States · 4 centers
- Hoag Memorial Hospital Presbyterian — Newport Beach
- University of California, Irvine Medical Center — Orange
- University of California, Davis Medical Center — Sacramento
- University of California, San Francisco Medical Center — San Francisco
Identifiers
NCT: NCT05586776 · 1304