RECRUITING

Decolonization to Reduce After-Surgery Events of Surgical Site Infection

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Decolonization to Reduce After-Surgery Events of Surgical Site Infection

Quick Facts

Study Start:2023-01-17
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05586776

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years of age or older
  2. * Recent open (not solely laparoscopic) surgery involving an abdominal incision within the past 14 days. For cesarean section, recruitment restricted to BMI ≥ 40.
  3. * Able to communicate regularly by phone
  4. * Able to bathe, shower or have this task performed by a caregiver
  1. * Transfer to an acute care hospital
  2. * Discharged to receive end-of-life hospice measures
  3. * Discharged more than 14 days after surgery
  4. * Allergic to mupirocin and/or chlorhexidine
  5. * Active infection at enrollment\*
  6. 1. Infections requiring systemic antibacterial agents, so viral illness (e.g., COVID, flu) is not an exclusion.
  7. 2. Topical antibacterial agents do not count toward exclusion (e.g., topical products for acne)
  8. 3. Prophylactic antibacterial agents do not count toward exclusion
  9. * Surgical incision not closed at discharge

Contacts and Locations

Study Contact

Susan Huang, MD, MPH
CONTACT
(949) 824-5073
sshuang@hs.uci.edu
Raveena Singh, MA
CONTACT
(949) 824-9285
ravsingh@hs.uci.edu

Principal Investigator

Susan Huang, MD, MPH
PRINCIPAL_INVESTIGATOR
University of California, Irvine
Deborah Yokoe, MD, MPH
STUDY_DIRECTOR
University of California, San Francisco
Stuart Cohen, MD
STUDY_DIRECTOR
University of California, Davis

Study Locations (Sites)

Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
United States
University of California, Irvine Medical Center
Orange, California, 92868
United States
University of California, Davis Medical Center
Sacramento, California, 95817
United States
University of California, San Francisco Medical Center
San Francisco, California, 94143
United States

Collaborators and Investigators

Sponsor: University of California, Irvine

  • Susan Huang, MD, MPH, PRINCIPAL_INVESTIGATOR, University of California, Irvine
  • Deborah Yokoe, MD, MPH, STUDY_DIRECTOR, University of California, San Francisco
  • Stuart Cohen, MD, STUDY_DIRECTOR, University of California, Davis

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-17
Study Completion Date2028-12

Study Record Updates

Study Start Date2023-01-17
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • Surgical Site Infection
  • SSI

Additional Relevant MeSH Terms

  • Surgical Site Infection