Durham, North Carolina 27705

  • Surgical Wound Infection

Purpose:

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.


Criteria:

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).


NCT ID:

NCT00203541


Primary Contact:

Study Director
Katie Kavounis, MPH
Tyco Healthcare/Kendall


Backup Contact:

N/A


Location Contact:

Durham, North Carolina 27705
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: April 07, 2020

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