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

Tyco Healthcare Group

Status: Terminated

Conditions: Surgical Wound Infection

Treatments: Device: TELFA™ A.M.D. Island dressing

Study type: Interventional

Funder types: Industry

Identifiers

NCT00203541

301.18

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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).