Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-01-04 @ 5:06 PM
Study NCT ID:
NCT03709693
Status:
TERMINATED
Last Update Posted:
2021-07-23
First Post:
2018-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcomes in Patients Treated With SternaLock Blu
Sponsor:
Zimmer Biomet
Organization:
Study Overview
Official Title:
Sternal Rigid Fixation: Evaluation of Clinical Outcomes Using Real-World Evidence
Status:
TERMINATED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
COVID 19 Pandemic
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SECURE
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: