Clinical trial NCT03365843: Montage-Enhanced Sternal Closure
Official title: Montage- Enhanced Sternal Closure to Accelerate Post-Operative Recovery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Sternal Closure
Keywords: Cardiac surgery
Sternal closure
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Abyrx, Inc.
First posted: 2017-12-07
Enrollment: 65
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, single centre, double-blind clinical study
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: 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

Primary outcomes:
measure: Recovery of Respiratory Function
timeFrame: Intervention to 6 weeks post-operative
measure: Radiographic Sternal Integrity
timeFrame: Intervention to 12 months post-operative
measure: Sternal Revision
timeFrame: Intervention to 12 months post-operative
Secondary outcomes:
measure: Post-operative Pain Assessment
timeFrame: Baseline to 12 months post - operative.
measure: Rate of post-operative recovery
timeFrame: Baseline to 12 months post-operative
measure: Rate of post-operative recovery
timeFrame: Baseline to 12 months post-operative
measure: Sternal Wound Infections
timeFrame: Baseline to 12 months post-operative
measure: Pulmonary Complications
timeFrame: Baseline to 6 weeks post-operative
measure: Health Services resource usage
timeFrame: Baseline to 12 months post-operative
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Paul WM Fedak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: