Decolonization to Reduce After-Surgery Events of Surgical Site Infection

Surgical Site Infection Clinical Trial

— DECREASE SSI  

Official title:

Decolonization to Reduce After-Surgery Events of Surgical Site Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05586776
• Other study ID #: 1304
• Status: Recruiting
• Phase: Phase 4
• Start date: January 17, 2023
• Est. completion date: December 2028

Study information

• Verified date: August 2023
• Source: University of California, Irvine
• Contact: Susan Huang, MD, MPH
• Phone: (949) 824-5073
• Email: sshuang[@]hs.uci.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2700
• Est. completion date: December 2028
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Drug:
• 4% Chlorhexidine Gluconate
Used for daily showering/bathing for 30 days after hospital discharge.
• 2% Mupirocin
Applied to each nostril twice daily for five days for the first two weeks after hospital discharge.
• Soap Without Antiseptic Properties (Placebo)
Used for daily showering/bathing for 30 days after hospital discharge.
• Placebo Nasal Ointment
Applied to each nostril twice daily for five days for the first two weeks after hospital discharge.

Locations

Country	Name	City	State
United States	University of California, Irvine Medical Center	Orange	California
United States	University of California, Davis Medical Center	Sacramento	California
United States	University of California, San Francisco Medical Center	San Francisco	California

Sponsors (4)

Lead Sponsor	Collaborator
University of California, Irvine	University of California, Davis, University of California, San Francisco, University of Massachusetts, Amherst

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to First Post-Discharge Surgical Site Infection		Within 30 Days of Hospital Discharge