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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2006-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Surgical Wound Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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TELFA™ A.M.D. Island dressing

Intervention Type DEVICE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Katie Kavounis, MPH

Role: STUDY_DIRECTOR

Tyco Healthcare/Kendall

Locations

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Duke University

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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301.18

Identifier Type: -

Identifier Source: org_study_id