Clinical trial NCT05586776: Decolonization to Reduce After-Surgery Events of Surgical Site Infection
Official title: Decolonization to Reduce After-Surgery Events of Surgical Site Infection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Surgical Site Infection
Keywords: Surgical Site Infection
SSI
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: University of California, Davis
name: University of California, San Francisco
name: University of Massachusetts, Amherst
name: Hoag Memorial Hospital Presbyterian
First posted: 2022-10-19
Enrollment: 2700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Primary outcomes:
measure: Time to First Post-Discharge Surgical Site Infection
timeFrame: Within 30 Days of Hospital Discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco Medical Center
state: California
Study officials:
affiliation: University of California, Irvine
name: Susan Huang, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Deborah Yokoe, MD, MPH
role: STUDY_DIRECTOR
affiliation: University of California, Davis
name: Stuart Cohen, MD
role: STUDY_DIRECTOR
References: