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Montage-Enhanced Sternal Closure

NCT03365843 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2021-09-28

No results posted yet for this study

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.

Conditions

  • Sternal Closure

Interventions

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.

Sponsors & Collaborators

  • Abyrx, Inc.

    collaborator INDUSTRY

  • University of Calgary

    lead OTHER

Principal Investigators

  • Paul WM Fedak, MD, PhD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2022-12-01
Completion
2022-12-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03365843 on ClinicalTrials.gov