NCT00203541TerminatedNot Applicable
Effects of a New Antimicrobial Dressing on Wound Healing and Incidence of Sternal Wound Infections in Subjects Who Have Undergone Cardiac Surgical Procedures Requiring Median Sternotomy
Tyco Healthcare Group1 site in 1 country1,100 target enrollmentStarted: February 1, 2004Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Tyco Healthcare Group
- Enrollment
- 1,100
- Locations
- 1
- Primary Endpoint
- Decreased cumulative incidence rate of superficial surgical site infections localized at the sternal incision in the treatment group as compared to the control group.
Study Overview
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 incidence rate(CI) of localized, superficial infections at the sternal incisional site as compared to the control group, regular, non-antimicrobial dressing.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Outcomes
Primary Outcomes
Decreased cumulative incidence rate of superficial surgical site infections localized at the sternal incision in the treatment group as compared to the control group.
Secondary Outcomes
- Reduction of microbial log counts at the incisional site in the treatment group compared to the control group; Decreased cumulative incidence of mediastinitis in the treatment group as compared to the control group
Investigators
Study Sites (1)
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