Post-operative recovery after cardiac surgery is influenced by early sternal bone stability. Traditional sternal closure of median sternotomy usually entails the use of 6-10 stainless steel wires. Augmenting sternal closure with techniques to enhance early bone stability should accelerate functional recovery from cardiac surgery thereby reducing post-operative pain, decreasing the need for narcotics, improving breathing and chest wall mechanics, stimulating early mobility and expediting hospital discharge. This study is a randomized, single-centre, double-blind clinical study comparing the effects of Montage bone putty plus conventional wire closure vs conventional wire closure only on the post-operative recovery of cardiac surgery patients with full medial sternotomy.
Patients undergoing cardiac surgery who are participating in the study will be randomized to either conventional wire cerclage or conventional wire closure plus the use of Montage bone putty. Patients will be followed post-operatively Day 3, 5 and at discharge as well as weeks 2, 4, 6 and months 3, 6 and 12. Each visit will include: Pain assessment, wound assessment, sternal assessment, analgesic/antibiotic use, spirometry testing, quality of life questionaries (EQ-5D/HAQ) and determination of any adverse events. Chest x-rays will done at discharge and 3, 6, and 12 months to look at sternal healing. This pilot study will include a total of 65 patient (40 conventional + putty / 20 conventional/ 5 initial open label with putty).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
65
Application of bone putty on cut sternal surfaces prior to application of conventional wires for closure of sternum during cardiac surgery.
Closure of sternum with standard wire cerclage.
University of Calgary
Calgary, Alberta, Canada
Recovery of Respiratory Function
The recovery of pulmonary functional capacity as measured by the return of forced vital capacity (FVC) to 80% or greater of the pre-operative baseline FVC measurement.
Time frame: Intervention to 6 weeks post-operative
Radiographic Sternal Integrity
No radiographic evidence of bony instability as assessed through serial chest x-rays
Time frame: Intervention to 12 months post-operative
Sternal Revision
Absence of device (wire or Montage bone putty) removal, revision or reoperation occurring over first 12 months post-operative.
Time frame: Intervention to 12 months post-operative
Post-operative Pain Assessment
Severity of post-operative pain (survey score and analgesic use) comparing treatment vs control groups
Time frame: Baseline to 12 months post - operative.
Rate of post-operative recovery
Rate of post-operative recovery as measured by health related quality of life (EQ5D) standardized assessment tool
Time frame: Baseline to 12 months post-operative
Rate of post-operative recovery
Rate of post-operative recovery as measured by physical functioning (HAQ) standardized assessment tool
Time frame: Baseline to 12 months post-operative
Sternal Wound Infections
Frequency of sternal wound infections (superficial and deep) between groups
Time frame: Baseline to 12 months post-operative
Pulmonary Complications
Post-operative pulmonary complications between groups
Time frame: Baseline to 6 weeks post-operative
Health Services resource usage
To compare the burden of health services resource usage between groups (total cost estimate)
Time frame: Baseline to 12 months post-operative
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