Mediastinitis Clinical Trial
Official title:
A Randomized, Controlled, Phase 4 Study of Sternal Plating (Rapid Sternal Closure System, KLS Martin L.P.) in Cardiac Surgical Subjects at Higher Risk for Sternal Wound Complications.
The primary objective is to establish if the Rapid Sternal Closure System (RSCS) improves
early postoperative recovery as manifested by decreased pain and improved pulmonary
function.
Secondary objectives include evaluation of Rapid Sternal Closure System with regard to SWCs
(surgical wound complication defined as surgically treated sternal wound infection and
sternal instability/non-union) as outlined in the protocol.
For a given study endpoint, the null hypothesis will be no difference between the Rapid
Sternal Closure System group and the control group. The alternative hypothesis will be a
difference between 2 groups. The statistical objective of this study is to reject the null
hypothesis in favor of the alternative hypothesis.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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