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

Not Applicable

Terminated

• Conditions: Surgical Wound Infection

• Registration Number: NCT00203541
• Lead Sponsor: Tyco Healthcare Group

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-20
• Study Completion: 2006-06
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-16
• Last Update Posted: 2007-11-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States