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Completed

NCT Number: NCT02385708

Use of 2% Chlorhexidine Cloths Reduce Surgical Site Infections

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).

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Key information

Conditions

Surgical Site Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University

Nashville, Tennessee, 37212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

2% Chlorohexidine Gluconate Standard of Care

Drug

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

2% Chlorohexidine Gluconate Chin to Toe

Drug

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 11, 2015
Registry last updated
Apr 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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