Clinical Outcomes in Patients Treated With SternaLock Blu (SECURE)

Zimmer Biomet

Status: Terminated

Conditions: Heart Valve Diseases; Coronary Artery Disease; Cardiac Surgical Procedures

Treatments: Device: SternaLock Blu

Study type: Observational

Funder types: Industry

Identifiers

NCT03709693

0518

Details and patient eligibility

About

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.

Full 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.

Enrollment: 156 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. ≥ 18 years of age, no upper limit

2. 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

3. Willing and able to return for follow-up

   Exclusion Criteria:

   Preoperative

4. Emergent or salvage cardiac acuity i.e., patients undergoing cardiopulmonary resuscitation en-route to the operating room or prior to induction of anesthesia

5. 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

6. Delayed sternal closure required for any reason

7. 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

8. Use of bone wax between the sternal halves

9. Intraoperative death prior to device placement

Trial design

156 participants in 1 patient group

SternaLock Blu

Description:

All patients will receive SternaLock Blu for closure of full mid-line sternotomy.

Treatment:

Device: SternaLock Blu