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

Surgical Wound Infection Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00203541
• Other study ID #: 301.18
• Status: Terminated
• Phase: N/A
• First received: September 12, 2005
• Last updated: November 16, 2007
• Start date: February 2004
• Est. completion date: June 2006

Study information

• Verified date: November 2007
• Source: Tyco Healthcare Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1100
• Est. completion date: June 2006
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Infection
• Surgical Wound Infection
• Wound Infection

Intervention

Device:
• TELFA™ A.M.D. Island dressing

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Tyco Healthcare Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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