Montage-Enhanced Sternal Closure

Sternal Closure Clinical Trial

Official title:

Montage- Enhanced Sternal Closure to Accelerate Post-Operative Recovery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03365843
• Other study ID #: REB17-1399
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 1, 2018
• Est. completion date: December 1, 2022

Study information

• Verified date: September 2021
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 79 Years

Eligibility

Inclusion Criteria:

• undergoing non-emergent cardiac surgery ( cabg only or one valve procedure)

• full median sternotomy approach, with or without cardiopulmonary bypass

• English speaking

• geographically accessible

• written consent

Exclusion Criteria:

• Recent CPR

• previous cardiac surgery

• emergency surgery ( within 24 hrs of assessment)

• chronic lung disease

• history of bleeding disorder

• currently taking Vitamin E supplements

• recent antiplatelet therapy

• excessively poor baseline health-related quality of life or physical functioning

• previous radiotherapy to chest, or on immunosuppressive drugs or current immunosuppressive condition

• active significant systemic infection, history of recurrent infections,

• cognitive impairment ( confusion, dementia, Alzheimer's, current substance abuse)

• history of malignancy within the past year

• recent history of significant alcohol or drug abuse

• females who are pregnant, nursing, or child bearing potential who are not practicing a highly reliable birth control method

• postsurgical life expectancy of less than 90 days

• moderate to severe pectus deformity

• participation in another study

Related Conditions & MeSH terms

• Sternal Closure

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Abyrx, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Intervention to 6 weeks post-operative
Primary	Radiographic Sternal Integrity	No radiographic evidence of bony instability as assessed through serial chest x-rays	Intervention to 12 months post-operative
Primary	Sternal Revision	Absence of device (wire or Montage bone putty) removal, revision or reoperation occurring over first 12 months post-operative.	Intervention to 12 months post-operative
Secondary	Post-operative Pain Assessment	Severity of post-operative pain (survey score and analgesic use) comparing treatment vs control groups	Baseline to 12 months post - operative.
Secondary	Rate of post-operative recovery	Rate of post-operative recovery as measured by health related quality of life (EQ5D) standardized assessment tool	Baseline to 12 months post-operative
Secondary	Rate of post-operative recovery	Rate of post-operative recovery as measured by physical functioning (HAQ) standardized assessment tool	Baseline to 12 months post-operative
Secondary	Sternal Wound Infections	Frequency of sternal wound infections (superficial and deep) between groups	Baseline to 12 months post-operative
Secondary	Pulmonary Complications	Post-operative pulmonary complications between groups	Baseline to 6 weeks post-operative
Secondary	Health Services resource usage	To compare the burden of health services resource usage between groups (total cost estimate)	Baseline to 12 months post-operative