At a glance
ClinicalIndex Comparison Record- ✓Patients undergoing full standard midline sternotomy for cardiac surgery (CABG and/or valve replacement with other cardiac procedures)
- ✓Age ≥18 years
- ✓BMI <40
- ✓Hospital admission on day of or day before scheduled surgery
- ✕End-stage renal failure on dialysis
- ✕Severe COPD (FEV1 <50% or home oxygen requirement)
- ✕Pre-operative narcotic use
- ✕Chronic steroids, biologic immunosuppressants, or chemotherapy (exception: steroid inhalers for asthma permitted)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Evaluation of Rigid Sternal Fixation in Supporting Bone Healing and Improving Postoperative Recovery: A Prospective, Randomized Trial
In Brief
A clinical study evaluating SternaLock Blue closure system and Suture Wire for Coronary Artery Disease and 2 related conditions. Completed, enrolled 236 participants across 12 sites.
Detailed Summary
The primary objective of this study is to evaluate sternal bone healing following a full median sternotomy versus standard of care for sternal closure with wire cerclage. Additional outcomes on post-operative pain and analgesic usage, patient function and quality of life, and complications will also be collected. A health economics study will also be conducted, in which cost and billing data will be collected from sites participating in this clinical study.
Study Details
Timeline
Interventions
SternaLock Blue closure system is a primary closure system plate-based
Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy.