Use of 2% Chlorhexidine Cloths Reduce Surgical Site Infections

Vanderbilt University

Status: Completed

Conditions: Surgical Site Infection

Treatments: Drug: 2% Chlorohexidine Gluconate Chin to Toe; Drug: 2% Chlorohexidine Gluconate Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT02385708

150309

Details and patient eligibility

About

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).

Full 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.

Enrollment: 163 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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163 participants in 2 patient groups

Standard of Care

Active Comparator group

Description:

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:

Drug: 2% Chlorohexidine Gluconate Standard of Care

Treatment Arm

Active Comparator group

Description:

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

Treatment:

Drug: 2% Chlorohexidine Gluconate Chin to Toe