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

November 16, 2007 updated by: Tyco Healthcare Group

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

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 Overview

Status

Terminated

Study Type

Interventional

Enrollment

1100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Katie Kavounis, MPH, Tyco Healthcare/Kendall

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Study Completion

June 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

November 19, 2007

Last Update Submitted That Met QC Criteria

November 16, 2007

Last Verified

November 1, 2007

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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