Surgical Site Infection
Conditions
Keywords
Surgical Site Infection, SSI
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.
Interventions
Used for daily showering/bathing for 30 days after hospital discharge.
DRUG2% Mupirocin
Applied to each nostril twice daily for five days for the first two weeks after hospital discharge.
DRUGSoap Without Antiseptic Properties (Placebo)
Used for daily showering/bathing for 30 days after hospital discharge.
DRUGPlacebo Nasal Ointment
Applied to each nostril twice daily for five days for the first two weeks after hospital discharge.
Sponsors
University of California, Irvine
University of California, Davis
University of California, San Francisco
University of Massachusetts, Amherst
Hoag Memorial Hospital Presbyterian
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to First Post-Discharge Surgical Site Infection | Within 30 Days of Hospital Discharge |
Countries
United States
Contacts
CONTACTSusan Huang, MD, MPH
CONTACTRaveena Singh, MA
PRINCIPAL_INVESTIGATORSusan Huang, MD, MPH
University of California, Irvine
STUDY_DIRECTORDeborah Yokoe, MD, MPH
University of California, San Francisco
STUDY_DIRECTORStuart Cohen, MD
University of California, Davis
Outcome results
None listed