TerminatedNot Applicable

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

Stopped: Reallocation of funding.

United States1,100 participantsStarted 2004-02

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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

What they're measuring

Decreased cumulative incidence rate of superficial surgical site infections localized at the sternal incision in the treatment group as compared to the control group.

Trial details

NCT IDNCT00203541

SponsorTyco Healthcare Group

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Surgical Wound Infection trials