Surgical Wound Infection
Conditions
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.
Interventions
DEVICETELFA™ A.M.D. Island dressing
Sponsors
Tyco Healthcare Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United States
Outcome results
None listed