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

This study has been terminated.

( Reallocation of funding. )

First Received: September 12, 2005 Last Updated: November 16, 2007 History of Changes

Sponsored by:	Tyco Healthcare Group
Information provided by:	Tyco Healthcare Group
ClinicalTrials.gov Identifier:	NCT00203541

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.

Condition	Intervention
Surgical Wound Infection	Device: TELFA™ A.M.D. Island dressing

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Active Control, Parallel Assignment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Surgery

U.S. FDA Resources

Further study details as provided by Tyco Healthcare Group:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	1100
Study Start Date:	February 2004
Estimated Study Completion Date:	June 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00203541

Locations

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

Sponsors and Collaborators

Tyco Healthcare Group

Investigators

Study Director:

Katie Kavounis, MPH

Tyco Healthcare/Kendall

More Information

No publications provided

Study ID Numbers:	301.18
Study First Received:	September 12, 2005
Last Updated:	November 16, 2007
ClinicalTrials.gov Identifier:	NCT00203541 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anti-Infective Agents
Postoperative Complications
Wounds and Injuries

Disorders of Environmental Origin
Surgical Wound Infection
Wound Infection

Additional relevant MeSH terms:

Anti-Infective Agents
Communicable Diseases
Pathologic Processes
Postoperative Complications
Therapeutic Uses
Wounds and Injuries

Disorders of Environmental Origin
Surgical Wound Infection
Infection
Pharmacologic Actions
Wound Infection

ClinicalTrials.gov processed this record on September 11, 2009