Use of 2% Chlorhexidine Cloths Reduce Surgical Site Infections

April 23, 2019 updated by: Steven Klintworth, Vanderbilt University

A Randomized Controlled Trial of 2% Chlorhexidine Gluconate Skin Preparation Cloths for the Prevention of Post-Operative Surgical Site Infections in Colorectal Patients

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

163

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Drug: 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.
Other Names:
  • 2% Chlorhexidine Gluconate
Active Comparator: Treatment Arm
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
Drug: 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
Other Names:
  • 2% Chlorohexidine Gluconate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Surgical Site Infections
Time Frame: 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.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Investigators

  • Principal Investigator: Steven R Klintworth, RN, Vanderbilt Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

June 21, 2018

Study Completion (Actual)

June 21, 2018

Study Registration Dates

First Submitted

March 5, 2015

First Submitted That Met QC Criteria

March 10, 2015

First Posted (Estimate)

March 11, 2015

Study Record Updates

Last Update Posted (Actual)

April 30, 2019

Last Update Submitted That Met QC Criteria

April 23, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 150309

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Surgical Site Infection

Clinical Trials on 2% Chlorohexidine Gluconate Standard of Care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe