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NCT Number: NCT05586776

Decolonization to Reduce After-Surgery Events of Surgical Site Infection

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.

Recruiting

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Key information

Conditions

Surgical Site Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4% Chlorhexidine Gluconate

Drug

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

2% Mupirocin

Drug

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

Soap Without Antiseptic Properties (Placebo)

Drug

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

Placebo Nasal Ointment

Drug

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

Primary outcomes

  1. Time to First Post-Discharge Surgical Site Infection

    Time frame: Within 30 Days of Hospital Discharge

Study contacts

Contact information is provided by the study sponsor or research team.

Raveena Singh, MA

CONTACT

[email protected]

(949) 824-9285

Susan Huang, MD, MPH

CONTACT

[email protected]

(949) 824-5073

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

  • Hoag Memorial Hospital Presbyterian
  • University of California, Davis
  • University of California, San Francisco
  • University of Massachusetts, Amherst

Registry information

Acronym: DECREASE SSI

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 19, 2022
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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