Effects of a New Antimicrobial Dressing on Wound Healing and Incidence of Sternal Wound Infections

Stopped early · Not applicable

Conditions studied: Surgical Wound Infection

In brief

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 incidence rate(CI) of localized, superficial infections at the sternal incisional site as compared to the control group, regular, non-antimicrobial dressing.

Key facts

Study ID

NCT00203541

Run by

Tyco Healthcare Group

People needed

1100

Starts

2004-02-01

Expected to finish

2006-06-01

Last updated by the study team

2007-11-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Duke University — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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