Clinical Trial: Rapid Sternal Closure System (TALON)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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.

Brief 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.


Detailed Summary:
Sponsor: Duke University

Current Primary Outcome: Percentage Change of Preoperative Incentive Spirometry (IS) Volume Achieved [ Time Frame: Baseline, Maximum value during postoperatively days 1 thru 7 ]

Maximum incentive spirometry volume was measured at baseline (prior to surgery) and daily from postoperative day 1 through postoperative day 7 (or discharge if earlier) using a Coach 2 incentive spirometer with one way valve (Coach 2 model # 22-4000, Smiths Medical, Keene, NH).


Original Primary Outcome: The primary objective is to establish if the Rapid Sternal Closure System improves early postoperative recovery as manifested by decreased pain and improved pulmonary function. [ Time Frame: Baseline, Postoperatively days 1 thru 7, 30 day, 60 day, 90 day, 180 day. ]

Current Secondary Outcome: Number of Participants With Sternal Wound Infection or Sternal Instability/Non-union [ Time Frame: Up to 180 days ]

The Data and Safety Monitoring Board reviewed source documents for all cases with possible sternal wound infection and sternal instability or non-union and made a determination as to the presence of these complications.


Original Secondary Outcome: Evaluation of Rapid Sternal Closure System with regard to sternal wound infection and sternal instability/non-union as outlined in the protocol. [ Time Frame: 30, 60, 90, 180 days ]

Information By: Duke University

Dates:
Date Received: March 12, 2008
Date Started: March 2008
Date Completion:
Last Updated: April 5, 2011
Last Verified: April 2011