Use of 2% Chlorhexidine Cloths Reduce Surgical Site Infections
- Conditions
- Surgical Site Infection
- Interventions
- Drug: 2% Chlorohexidine Gluconate Standard of CareDrug: 2% Chlorohexidine Gluconate Chin to Toe
- Registration Number
- NCT02385708
- Lead Sponsor
- Vanderbilt University
- Brief Summary
Use of 2% chlorhexidine gluconate cloths pre-operatively and daily post-operatively jaw line to toes will decrease surgical site infections (SSI) by 30% when compared to patients who receive routine standard of care (use of chlorhexidine cloths night before surgery and morning of surgery).
- Detailed Description
Patients undergoing colorectal surgery will be randomized in a 1:1 fashion into two groups. One will be standard of care using 2% Chlorhexidine Gluconate wipes night before surgery and morning if surgery. The second group will be randomized into the study arm using 2% Chlorhexidine Gluconate clothes from jaw line to toes night before surgery, morning of surgery and daily post operative. Skin cultures will be obtained at time of consent, prior to surgical procedure before surgical scrub and draping, post operative day 4 and at 30 day follow up visit. Incision lines will be assessed daily by study staff for signs of surgical site infection utilizing the CDC's 3 definitions of surgical site infections, superficial incisional SSI, deep incisional SSI, and organ space SSI.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 163
-
- Patients > 18 years old scheduled for a colorectal surgical procedure ASA>2 OR pre-operatively hospitalized
- Unable to consent
- Known allergy to any of the ingredients contained in SAGE chlorhexidine gluconate cloths
- Current infection or history of abdominal infections.
- Patients on chronic steroids or immunosuppressive medications.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of Care 2% Chlorohexidine Gluconate Standard of Care Patients will perform the current standard of care treatment using 2% Chlorohexidine Gluconate Cloths on the abdomen and buttocks prior to colorectal surgery night before surgery and morning of surgery Treatment Arm 2% Chlorohexidine Gluconate Chin to Toe Patients will perform treatment with 2% Chlorohexidine Gluconate cloths chin to toe night before and morning of surgery then daily post operative until post op day 4 or discharge
- Primary Outcome Measures
Name Time Method Incidence of Surgical Site Infections 30 days Number of participants who had surgical site infection development at 30 day post operative visit based on Center for Disease Control Criteria for Defining A Surgical Site Infection (SSI), 2011.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Vanderbilt University
🇺🇸Nashville, Tennessee, United States