Decolonization to Reduce After-Surgery Events of Surgical Site Infection

Study Overview
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Brief Summary
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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
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Decolonization to Reduce After-Surgery Events of Surgical Site Infection

Conditions
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Surgical Site Infection

Intervention / Treatment
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* Drug: 4% Chlorhexidine Gluconate
* Drug: 2% Mupirocin
* Drug: Soap Without Antiseptic Properties (Placebo)
* Drug: Placebo Nasal Ointment


Participation Criteria
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Eligibility Criteria
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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 Infections requiring systemic antibacterial agents, so viral illness (e.g., COVID, flu) is not an exclusion. Topical antibacterial agents do not count toward exclusion (e.g., topical products for acne) Prophylactic antibacterial agents do not count toward exclusion Surgical incision not closed at discharge

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Decolonization<br>Participants randomized into this arm will perform decolonization using topical antiseptic soap (chlorhexidine body wash) and an antibiotic ointment (nasal mupirocin). | Drug: 4% Chlorhexidine Gluconate<br>* Used for daily showering/bathing for 30 days after hospital discharge.<br>Drug: 2% Mupirocin<br>* Applied to each nostril twice daily for five days for the first two weeks after hospital discharge.<br>|
| Placebo Comparator: Routine Care<br>Participants randomized into this arm will perform routine care using soap without antiseptic properties (placebo) and placebo nasal ointment. | Drug: Soap Without Antiseptic Properties (Placebo)<br>* Used for daily showering/bathing for 30 days after hospital discharge.<br>Drug: Placebo Nasal Ointment<br>* Applied to each nostril twice daily for five days for the first two weeks after hospital discharge.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Post-Discharge Surgical Site Infection |  | Within 30 Days of Hospital Discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SSI, Surgical Site Infection