Clinical Outcomes in Patients Treated With SternaLock Blu — SECURE  

Coronary Artery Disease Clinical Trial

Official title: Sternal Rigid Fixation: Evaluation of Clinical Outcomes Using Real-World Evidence

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cardiac Surgical Procedures
• Coronary Artery Disease
• Heart Valve Diseases

• NCT number: NCT03709693
• Study type: Observational [Patient Registry]
• Source: Zimmer Biomet
• Status: Terminated
• Start date: May 14, 2019
• Completion date: May 13, 2020