Eliminate Risk of Cardiac Surgical Site Events

University of Rochester739 enrolled

Overview

The purpose of the study is to see if using 2% Chlorhexidine cloths will reduce surgical site infections in patients having elective cardiac surgery.

A randomized, prospective study utilizing 2% Chlorhexidine cloths to evaluate the product's effectiveness in reducing surgical site infections in elective cardiothoracic surgery patients. Sage 2% chlorhexidine cloths are approved by the Food and Drug Administration (FDA) for preparation of skin prior to surgery. The study hypothesis is that the preoperative surgical preparation with 2% chlorhexidine cloths, which leaves chlorhexidine on the skin, will reduce surgical site infections by 50% as compared to current standard procedure.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

739

Conditions

Surgical Site Infections

Interventions

2% Chlorhexidine Gluconate clothsOTHER

2% chlorhexidine Gluconate wipes will bw used 12 hours prior to cardiac surgery and then again 3 hours prior to cardiac surgery. Subjects will be randomized to either receive a preoperative phone call reminder or no phone call reminder.

Standard of Care preoperative preparation.OTHER

Preoperative standard of care preparation utilized at the clinical site will be used. Subjects will be randomized to either receive a preoperative phone call reminder or no phone call reminder.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Elective cardiothoracic surgery patients \> 18 years old. * Informed consent obtained Exclusion Criteria: * Any current known allergies to chlorhexidine gluconate * Currently taking any oral or topical antibiotics * Any active skin rashes or breaks in the skin on areas to be treated with chlorhexidine gluconate * A current active skin disease or inflammatory skin condition, known pre-existing skin infection, including contact dermatitis that is currently being treated with an antibiotic * Any medical condition or use of any medications that in the opinion of the Principal Investigator preclude participation. * Unwillingness or failure to fulfill requirements of the study

Locations (4)

University of Kentucky

Lexington, Kentucky, United States

The Valley Hospital

Ridgewood, New Jersey, United States

University of Rochester Medical Center

Rochester, New York, United States

Robert Packer Hospital

Sayre, Pennsylvania, United States

Outcomes

Primary Outcomes

Surgical site infections

Subjects will be assessed at 30 days and 90 days post operatively for any surgical site infection

Time frame: Through 90 days post procedure

Data from ClinicalTrials.gov

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