Eliminate Risk of Cardiac Surgical Site Events

Not Applicable

Completed

• Conditions: Surgical Site Infections
• Interventions: Other: 2% Chlorhexidine Gluconate cloths; Other: Standard of Care preoperative preparation.

• Registration Number: NCT01425697
• Lead Sponsor: University of Rochester

Brief Summary

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

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2011-08-22
• Study First Submitted QC: 2011-08-28
• Study First Posted: 2011-08-30
• Primary Completion: 2012-07
• Study Completion: 2012-09
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-28
• Last Update Posted: 2013-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 739

Inclusion Criteria

• Elective cardiothoracic surgery patients > 18 years old.
• Informed consent obtained

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2% Chlorhexidine Gluconate cloths	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
2% Chlorhexidine Gluconate cloths	Standard of Care preoperative preparation.	2% Chlorhexidine Gluconate wipes will be used 12 hours prior to cardiac surgery and then again 3 hours prior to cardiac surgery
Standard of Care Preoperative Preparation	2% Chlorhexidine Gluconate cloths	Subject will receive standard of care preoperative preparation for the clinical site.
Standard of Care Preoperative Preparation	Standard of Care preoperative preparation.	Subject will receive standard of care preoperative preparation for the clinical site.

Primary Outcome Measures

Name	Time	Method
Surgical site infections	Through 90 days post procedure	Subjects will be assessed at 30 days and 90 days post operatively for any surgical site infection

Trial Locations

Locations (4)

The Valley Hospital; 🇺🇸 Ridgewood, New Jersey, United States

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States

Robert Packer Hospital; 🇺🇸 Sayre, Pennsylvania, United States