DECREASE SSI: Decolonization to Reduce After-Surgery Events of Surgical Site Infection

• Sponsor: University of California, Irvine (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05586776
• Collaborator: University of California, Davis (Other), University of California, San Francisco (Other), University of Massachusetts, Amherst (Other)
• Enrollment: 2,700
• Locations: 3
• Arms: 2
• Anticipated Duration (Months): 71
• Patients Per Site: 900
• Patients Per Site Per Month: 12.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Surgical Site Infection	Drug: 4% Chlorhexidine Gluconate; Drug: 2% Mupirocin; Drug: Soap Without Antiseptic Properties (Placebo); Drug: Placebo Nasal Ointment	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 2700 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Decolonization to Reduce After-Surgery Events of Surgical Site Infection
• Anticipated Study Start Date: Jan 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2027
• Anticipated Study Completion Date: Dec 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Decolonization Participants randomized into this arm will perform decolonization using topical antiseptic soap (chlorhexidine body wash) and an antibiotic ointment (nasal mupirocin).	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.
Placebo Comparator: Routine Care Participants randomized into this arm will perform routine care using soap without antiseptic properties (placebo) and placebo nasal ointment.	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.

Outcome Measures

Primary Outcome Measures

1. Time to First Post-Discharge Surgical Site Infection [Within 30 Days of Hospital Discharge]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 years of age or older

• Recent surgery that involves the colon or small bowel using an open (non-laparoscopic) approach within the past 14 days

• 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

• Surgical incision not closed at the end of surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Irvine Medical Center	Orange	California	United States	92868
2	University of California, Davis Medical Center	Sacramento	California	United States	95817
3	University of California, San Francisco Medical Center	San Francisco	California	United States	94143

Sponsors and Collaborators

• University of California, Irvine
• University of California, Davis
• University of California, San Francisco
• University of Massachusetts, Amherst

Investigators

• Principal Investigator: Susan Huang, MD, MPH, University of California, Irvine
• Study Director: Deborah Yokoe, MD, MPH, University of California, San Francisco
• Study Director: Stuart Cohen, MD, University of California, Davis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Susan Huang, Professor, Division of Infectious Diseases and Medical Director, Epidemiology and Infection Prevention, University of California, Irvine
• ClinicalTrials.gov Identifier: NCT05586776
• Other Study ID Numbers: 1304
• First Posted: Oct 19, 2022
• Last Update Posted: Dec 23, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Susan Huang, Professor, Division of Infectious Diseases and Medical Director, Epidemiology and Infection Prevention, University of California, Irvine: Surgical Site Infection; SSI
• Additional relevant MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection; Chlorhexidine; Chlorhexidine gluconate; Anti-Infective Agents, Local; Mupirocin

Study Results

No Results Posted as of Dec 23, 2022