Decolonization to Reduce After-Surgery Events of Surgical Site Infection

RECRUITING

I'm interested ...!!

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

🗓️ Study Start (Actual) 17 January 2023

🗓️ Primary Completion (Estimated) December 2027

✅ Study Completion (Estimated) December 2028

👥 Enrollment (Estimated) 2700

🔬 Study Type INTERVENTIONAL

📊 Phase PHASE4

Locations:

📍 Orange, California, United States

📍 Sacramento, California, United States

📍 San Francisco, California, United States

📋 Eligibility Criteria

Description

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

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ 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

First Submitted 15 October 2022
First Submitted that Met QC Criteria 15 October 2022
First Posted 19 October 2022

Study Record Updates

Last Update Submitted that Met QC Criteria 9 August 2023
Last Update Posted 14 August 2023
Last Verified August 2023