Status:

COMPLETED

Eliminate Risk of Cardiac Surgical Site Events

Lead Sponsor:

University of Rochester

Collaborating Sponsors:

Sage Products, Inc.

Conditions:

Surgical Site Infections

Eligibility:

All Genders

18+ years

Phase:

NA

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% chlo...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

November 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2012

Estimated Enrollment :

739 Patients enrolled

Trial Details

Trial ID

NCT01425697

Start Date

November 1 2008

End Date

September 1 2012

Last Update

July 2 2013

Active Locations (4)

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Page 1 of 1 (4 locations)

1

University of Kentucky

Lexington, Kentucky, United States

2

The Valley Hospital

Ridgewood, New Jersey, United States

3

University of Rochester Medical Center

Rochester, New York, United States, 14642

4

Robert Packer Hospital

Sayre, Pennsylvania, United States

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