Trials / Terminated
TerminatedNCT03709693
Clinical Outcomes in Patients Treated With SternaLock Blu
Sternal Rigid Fixation: Evaluation of Clinical Outcomes Using Real-World Evidence
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 156 (actual)
- Sponsor
- Zimmer Biomet · Industry
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Accepted
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.
Detailed description
The primary endpoint for this study is the rate of deep sternal wound infection (DSWI) at 30 days post-operative, following a midline sternotomy closed with SternaLock Blu. 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 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 Post-operative sternal wound complications occurring within 90 days post-operative. Outcomes will be reported up to 90 days after surgery, including data on adverse events associated with the use of SternaLock Blu Sternal Closure System from the moment of implantation to the end-of-study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SternaLock Blu | Sternal closure will be accomplished using SternaLock Blu plates and screws in combination with single-wire method of sternal reduction. |
Timeline
- Start date
- 2019-05-14
- Primary completion
- 2020-05-13
- Completion
- 2020-05-13
- First posted
- 2018-10-17
- Last updated
- 2021-07-23
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03709693. Inclusion in this directory is not an endorsement.