NCT00638014

Rapid Sternal Closure System (TALON)

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Sternal Wound Infection
• Mediastinitis

Interventions

Type	Name	Description
DEVICE	Rapid Sternal Closure System	Sternal talons will be used and supplemented with wires
DEVICE	Conventional wire closure	Conventional wire closure of sternum

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2008-03-18
• Last updated: 2011-05-02
• Results posted: 2011-05-02

Locations

1 site across 1 country: United States