Decolonization to Reduce After-Surgery Events of Surgical Site Infection

Phase 4

Recruiting

• Conditions: Surgical Site Infection
• Interventions: Drug: Soap Without Antiseptic Properties (Placebo); Drug: 4% Chlorhexidine Gluconate; Drug: 2% Mupirocin; Drug: Placebo Nasal Ointment

• Registration Number: NCT05586776
• Lead Sponsor: University of California, Irvine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-15
• Study First Submitted QC: 2022-10-15
• Study First Posted: 2022-10-19
• Study Start: 2023-01-17
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-26
• Primary Completion: 2027-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2700

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Decolonization	2% Mupirocin	Participants randomized into this arm will perform decolonization using topical antiseptic soap (chlorhexidine body wash) and an antibiotic ointment (nasal mupirocin).
Routine Care	Soap Without Antiseptic Properties (Placebo)	Participants randomized into this arm will perform routine care using soap without antiseptic properties (placebo) and placebo nasal ointment.
Routine Care	Placebo Nasal Ointment	Participants randomized into this arm will perform routine care using soap without antiseptic properties (placebo) and placebo nasal ointment.
Decolonization	4% Chlorhexidine Gluconate	Participants randomized into this arm will perform decolonization using topical antiseptic soap (chlorhexidine body wash) and an antibiotic ointment (nasal mupirocin).

Primary Outcome Measures

Name	Time	Method
Time to First Post-Discharge Surgical Site Infection	Within 30 Days of Hospital Discharge

Trial Locations

Locations (4)

Hoag Memorial Hospital Presbyterian; 🇺🇸 Newport Beach, California, United States

University of California, San Francisco Medical Center; 🇺🇸 San Francisco, California, United States

University of California, Irvine Medical Center; 🇺🇸 Orange, California, United States

University of California, Davis Medical Center; 🇺🇸 Sacramento, California, United States