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Decolonization to Reduce After-Surgery Events of Surgical Site Infection

NCT05586776 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2700

Last updated 2025-07-28

No results posted yet for this study

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.

Conditions

  • Surgical Site Infection

Interventions

DRUG

4% Chlorhexidine Gluconate

Used for daily showering/bathing for 30 days after hospital discharge.

DRUG

2% Mupirocin

Applied to each nostril twice daily for five days for the first two weeks after hospital discharge.

DRUG

Soap Without Antiseptic Properties (Placebo)

Used for daily showering/bathing for 30 days after hospital discharge.

DRUG

Placebo Nasal Ointment

Applied to each nostril twice daily for five days for the first two weeks after hospital discharge.

Sponsors & Collaborators

  • University of California, Davis

    collaborator OTHER

  • University of California, San Francisco

    collaborator OTHER

  • University of Massachusetts, Amherst

    collaborator OTHER

  • Hoag Memorial Hospital Presbyterian

    collaborator OTHER

  • University of California, Irvine

    lead OTHER

Principal Investigators

  • Susan Huang, MD, MPH · University of California, Irvine

  • Deborah Yokoe, MD, MPH · University of California, San Francisco

  • Stuart Cohen, MD · University of California, Davis

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-17
Primary Completion
2027-01-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05586776 on ClinicalTrials.gov