Rapid Sternal Closure System (TALON) (TALON)
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.
|Sternal Wound Infection Mediastinitis||Device: Rapid Sternal Closure System Device: Conventional wire closure||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Prevention
|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.|
- 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.
|Study Start Date:||March 2008|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00638014
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Elliott Bennett-Guerrero, M. D.||Duke University|