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

N/ATerminatedNCT00203541

Tyco Healthcare Group1,100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

1,100

Conditions

Surgical Wound Infection

Interventions

TELFA™ A.M.D. Island dressingDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Duke University

Durham, North Carolina, United States

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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