Clinical Outcomes in Patients Treated With SternaLock Blu
Stopped early
Conditions studied: Cardiac Surgical Procedures, Coronary Artery Disease, Heart Valve Diseases
In brief
The primary objective of this study is to evaluate the rate of deep sternal wound infection at 30 days post-operative following a full median sternotomy in patients treated with SternaLock Blu for rigid sternal fixation. This study will also provide evidence of the clinical performance of SternaLock Blu for up to 90 days using real world evidence methodology. Sternal complications will be reported through 90 days follow up.
Key facts
- Study ID
- NCT03709693
- Run by
- Zimmer Biomet
- People needed
- 156
- Starts
- 2019-05-14
- Expected to finish
- 2020-05-13
- Last updated by the study team
- 2021-07-23
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- ≥ 18 years of age, no upper limit
- Undergoing a full standard midline sternotomy as part of an elective or urgent cardiac surgical procedure [i.e., coronary artery bypass graft (CABG) and/ or valve replacement along with other cardiac surgical procedures] and closed with the SternaLock Blu Sternal Closure System
- Willing and able to return for follow-up
You may not qualify if…
- Preoperative
- Emergent or salvage cardiac acuity i.e., patients undergoing cardiopulmonary resuscitation en-route to the operating room or prior to induction of anesthesia
- Any contraindication listed in the SternaLock Blu instructions for use (IFU/ Appendix 3) (active infection, foreign body sensitivity, or mental/ neurologic conditions who are unwilling or incapable of following post-operative care instructions) Operative
- Delayed sternal closure required for any reason
- Intra-operative conditions that, in the opinion of the operating surgeon, would preclude the use of rigid plate fixation, i.e.: insufficient quantity of sternal bone or compressible sternum indicating poor bone quality, as assessed by the operating surgeon using his or her professional judgment at the time of closure
- Use of bone wax between the sternal halves
- Intraoperative death prior to device placement
Where it is running
- St. Franciscan Health — Indianapolis, Indiana, United States
- Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States
- Cardiovascular Surgery Clinic, PLLC — Memphis, Tennessee, United States
- University of Virginia — Charlottesville, Virginia, United States
Full record on ClinicalTrials.gov
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