Decolonization to Reduce After-Surgery Events of Surgical Site Infection

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.

Conditions

Surgical Site Infection

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Study Overview

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Study Details

Study 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.

Decolonization to Reduce After-Surgery Events of Surgical Site Infection

Decolonization to Reduce After-Surgery Events of Surgical Site Infection

Condition
Surgical Site Infection
Intervention / Treatment

-

Contacts and Locations

Newport Beach

Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States, 92663

Orange

University of California, Irvine Medical Center, Orange, California, United States, 92868

Sacramento

University of California, Davis Medical Center, Sacramento, California, United States, 95817

San Francisco

University of California, San Francisco Medical Center, San Francisco, California, United States, 94143

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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\*
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2028-12