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Use of 2% Chlorhexidine Cloths Reduce Surgical Site Infections

Not Applicable
Completed
Conditions
Surgical Site Infection
Interventions
Drug: 2% Chlorohexidine Gluconate Standard of Care
Drug: 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
Inclusion Criteria
    1. Patients > 18 years old scheduled for a colorectal surgical procedure ASA>2 OR pre-operatively hospitalized
Exclusion Criteria
  • 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
GroupInterventionDescription
Standard of Care2% Chlorohexidine Gluconate Standard of CarePatients 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 Arm2% Chlorohexidine Gluconate Chin to ToePatients 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
NameTimeMethod
Incidence of Surgical Site Infections30 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
NameTimeMethod

Trial Locations

Locations (1)

Vanderbilt University

🇺🇸

Nashville, Tennessee, United States

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