Health TrialsbyHealthPanel

Decolonization to Reduce After-Surgery Events of Surgical Site Infection

ConditionSurgical Site Infection
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Irvine

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

2,700 Participants
are divided into 2 treatment groups
Group A: DecolonizationActive comparator 2 interventions
Group B: Routine CarePlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Time to First Post-Discharge Surgical Site Infection

Time frame
Within 30 Days of Hospital Discharge

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Irvine

Lead sponsor

University of California, Davis

Collaborator

University of California, San Francisco

Collaborator

University of Massachusetts, Amherst

Collaborator

Hoag Memorial Hospital Presbyterian

Collaborator

Source ClinicalTrials.gov
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