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Decolonization to Reduce After-Surgery Events of Surgical Site Infection

Decolonization to Reduce After-Surgery Events of Surgical Site Infection

Recruiting
18 years and older
All
Phase 4

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Overview

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.

Eligibility

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 details
    Surgical Site Infection

NCT05586776

University of California, Irvine

27 January 2024

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FAQs

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What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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