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NCT03709693 · ClinicalTrials.gov registry record
Clinical Outcomes in Patients Treated With SternaLock Blu
A clinical trial, sponsored by Zimmer Biomet.
- Terminated
- Registry status
- 156
- Enrollment target
NCT03709693: Clinical Trial study, sponsored by Zimmer Biomet.
NCT03709693 is a clinical trial that was terminated before completion, run by Zimmer Biomet. The registered enrollment target is 156 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03709693 was terminated before completion, sponsored by Zimmer Biomet.
- TERMINATED
- Registry status
- 156 participants
- Enrollment target
Study Summary
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.
Primary Outcome
DSWI is defined as deep infection involving muscle, bone, and/ or mediastinum requiring operative intervention and has all of the following conditions: 1. Wound opened with excision of tissue (I\&D) or re-exploration of mediastinum 2. Positive culture unless patient on antibiotics at the time of culture or no culture obtained 3. Treatment with antibiotics beyond perioperative prophylaxis
Interventions
- DEVICE SternaLock Blu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2019-05-14 |
| Est. Completion | 2020-05-13 |
Why NCT03709693 stopped before completion
NCT03709693 is an observational study that tracks outcomes without assigning an intervention. The registered 156 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which SternaLock Blu is the first listed.
NCT03709693 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03709693 about?
NCT03709693 is a clinical study titled "Clinical Outcomes in Patients Treated With SternaLock Blu". 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...
What is the current status of trial NCT03709693?
This trial is currently terminated. The enrollment target is 156 participants. The study started on 2019-05-14. Estimated completion is 2020-05-13.
What interventions are being tested in trial NCT03709693?
The interventions under investigation include: SternaLock Blu (DEVICE).
Who is sponsoring clinical trial NCT03709693?
This trial is sponsored by Zimmer Biomet, which has 115 total clinical trials registered on ClinicalTrials.gov.
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