Clinical trial NCT03709693: Clinical Outcomes in Patients Treated With SternaLock Blu
Official title: Sternal Rigid Fixation: Evaluation of Clinical Outcomes Using Real-World Evidence
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cardiac Surgical Procedures
Coronary Artery Disease
Heart Valve Diseases
Keywords: sternotomy
rigid fixation
sternal fixation
sternal plating
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2018-10-17
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 2000 subjects total (+/- 20) from up to 20 sites

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.

Eligibility 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

Primary outcomes:
measure: Deep Sternal Wound Infection Rate
timeFrame: at 30 days post operatively up to 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: St. Franciscan Health
state: Indiana
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
city: Memphis
country: United States
facility: Cardiovascular Surgery Clinic, PLLC
state: Tennessee
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: St. Luke's Hospital
name: Keith Allen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St Franciscan Health
name: Marc Gerdisch, MD
role: PRINCIPAL_INVESTIGATOR
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