NCT03365843

Montage-Enhanced Sternal Closure

Montage- Enhanced Sternal Closure to Accelerate Post-Operative Recovery

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 19 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Sternal Closure

Interventions

Type	Name	Description
DEVICE	Montage bone putty	Application of bone putty on cut sternal surfaces prior to application of conventional wires for closure of sternum during cardiac surgery.
OTHER	Conventional Sternal Closure	Closure of sternum with standard wire cerclage.

Timeline

• Start date: 2018-10-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2017-12-07
• Last updated: 2021-09-28

Locations

1 site across 1 country: Canada