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
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
Treatments tested in this trial
- 4% Chlorhexidine Gluconate
- 2% Mupirocin
- Soap Without Antiseptic Properties (Placebo)
- Placebo Nasal Ointment
Treatment groups
2,700 Participants
are divided into 2 treatment groupsSponsors and collaborators
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