Montage-Enhanced Sternal Closure

U

University of Calgary

Status and phase

Unknown
Phase 2

Conditions

Sternal Closure

Treatments

Device: Montage bone putty
Other: Conventional Sternal Closure

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03365843
REB17-1399

Details and patient eligibility

About

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.

Full 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).

Enrollment

65 patients

Sex

All

Ages

19 to 79 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

65 participants in 2 patient groups

Montage bone putty
Experimental group
Description:
Sternal closure with conventional wire cerclage plus Montage bone putty
Treatment:
Other: Conventional Sternal Closure
Device: Montage bone putty
Conventional Sternal Closure
Active Comparator group
Description:
Conventional wire cerclage sternal closure only -- standard care.
Treatment:
Other: Conventional Sternal Closure

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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