Rapid Sternal Closure System (TALON) (TALON)
|ClinicalTrials.gov Identifier: NCT00638014|
Recruitment Status : Completed
First Posted : March 18, 2008
Results First Posted : May 2, 2011
Last Update Posted : May 2, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Sternal Wound Infection Mediastinitis||Device: Rapid Sternal Closure System Device: Conventional wire closure||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
Active Comparator: 1
Conventional wires only
Device: Conventional wire closure
Conventional wire closure of sternum
Rapid Sternal Closure System supplemented with wires
Device: Rapid Sternal Closure System
Sternal talons will be used and supplemented with wires
- 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).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00638014
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Elliott Bennett-Guerrero, M. D.||Duke University|