Eliminate Risk of Cardiac Surgical Site Events

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

739 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2012-09-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Surgical Site Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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2% Chlorhexidine Gluconate cloths

2% Chlorhexidine Gluconate wipes will be used 12 hours prior to cardiac surgery and then again 3 hours prior to cardiac surgery

Group Type ACTIVE_COMPARATOR

2% Chlorhexidine Gluconate cloths

Intervention Type OTHER

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.

Intervention Type 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.

Standard of Care Preoperative Preparation

Subject will receive standard of care preoperative preparation for the clinical site.

Group Type OTHER

2% Chlorhexidine Gluconate cloths

Intervention Type OTHER

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.

Intervention Type 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.

Interventions

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2% Chlorhexidine Gluconate cloths

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.

Intervention Type OTHER

Standard of Care preoperative preparation.

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes