Sternal Closure With SternaLock 360: First in Man Study (NCT02686099) | Clinical Trial Compass
CompletedNot Applicable
Sternal Closure With SternaLock 360: First in Man Study
South Africa50 participantsStarted 2015-07-04
Plain-language summary
The SternaLock 360 Sternal Closure Device combines the techniques of rigid fixation with a cerclage material into a single sternal closure system. The cerclage material serves to facilitate sternal approximation, and the plates and screws serve to provide rigid fixation and prevent sternal movement and separation. The combination of a cerclage material in combination with plate and screw fixation may also lead to increased stability compared to either method used as a standalone means of closure.
Who can participate
Age range30 Years
SexALL
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Inclusion Criteria:
* Patients undergoing a standard midline sternotomy as a result of a cardiac surgical procedure (i.e. coronary artery bypass graft (CABG) and/or valve replacement along with other cardiac surgical procedures)
* Patients ≥ 30 years of age
* Patients who sign the Informed Consent
Exclusion Criteria: Pre-Operative
* Patients with endstage renal failure who are on dialysis or post transplant patients
* Patients taking chronic (\>30 days) pre-operative narcotics
* Patients taking chronic (\>30 days) steroids, immunosuppressant (including biologic immunosuppressants such as Enbrel), or chemotherapeutics (e.g. methotrexate). Patients using a steroid inhaler for asthma should not be excluded.
* Patients with confirmed HIV with a viral load of \>10,000 copies
* Patients with an active infection that is currently being treated
* Patients with history or confirmed metal allergy or foreign body sensitivity
* Patients with a previous partial or full midline sternotomy
* Patients with previous radiation treatment of the chest
* Patients defined within the New York Heart Association (NYHA) or Canadian Cardiovascular Society (CCS) functional Class IV for congestive heart failure: i.e., patients with cardiac disease resulting in inability to carry on any physical activity without discomfort (CCS ; NYHA)
* Patients presenting emergent/salvage cardiac acuity as defined per the Society of Thoracic Surgeons (STS) guidelines: i.e., patients undergoing cardiopulmonary resusci…