Status:
TERMINATED
Effects of a New Antimicrobial Dressing on Wound Healing and Incidence of Sternal Wound Infections
Lead Sponsor:
Tyco Healthcare Group
Conditions:
Surgical Wound Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary objective of this pivotal study is to determine if a new antimicrobial dressing, applied to the sternal incisions of cardiac surgical subjects, will demonstrate a decreased cumulative inci...
Eligibility Criteria
Inclusion
- Sign an informed consent form that has been approved by the Institutional Review Board.
- Adults at least 18 years of age.
- Be undergoing cardiopulmonary bypass surgery with a median sternotomy.
- Be able to return to the study site, if needed, to have the sternal surgical incision site inspected.
Exclusion
- Be participating concurrently in another clinical trial that involves an investigational drug or device that would interfere with this study.
- Be in need of a left ventricular assist device.
- Have an active pre-operative infectious process.
- Subject is to receive another topical antimicrobial agent (i.e., Dermabond® Topical Skin Adhesive) other than the study dressing (as assigned by the randomization schedule).
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
1100 Patients enrolled
Trial Details
Trial ID
NCT00203541
Start Date
February 1 2004
End Date
June 1 2006
Last Update
November 19 2007
Active Locations (1)
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1
Duke University
Durham, North Carolina, United States, 27705