Sternal Closure
Conditions
Keywords
Cardiac surgery, Sternal closure
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).
Interventions
DEVICEMontage bone putty
Application of bone putty on cut sternal surfaces prior to application of conventional wires for closure of sternum during cardiac surgery.
OTHERConventional Sternal Closure
Closure of sternum with standard wire cerclage.
Sponsors
Abyrx, Inc.
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
The participants, study coordinator and care-givers are blinded to the assigned treatment arm. Participants may be able to guess which treatment group they have been assigned. This will be assessed at the end of the study by asking participants to identify the group to which they think they have been assigned.
Intervention model description
Randomized, single centre, double-blind clinical study
Eligibility
Sex/Gender
ALL
Age
19 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recovery of Respiratory Function | Intervention to 6 weeks post-operative | 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. |
| Radiographic Sternal Integrity | Intervention to 12 months post-operative | No radiographic evidence of bony instability as assessed through serial chest x-rays |
| Sternal Revision | Intervention to 12 months post-operative | Absence of device (wire or Montage bone putty) removal, revision or reoperation occurring over first 12 months post-operative. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Pain Assessment | Baseline to 12 months post - operative. | Severity of post-operative pain (survey score and analgesic use) comparing treatment vs control groups |
| Rate of post-operative recovery | Baseline to 12 months post-operative | Rate of post-operative recovery as measured by health related quality of life (EQ5D) standardized assessment tool |
| Sternal Wound Infections | Baseline to 12 months post-operative | Frequency of sternal wound infections (superficial and deep) between groups |
| Pulmonary Complications | Baseline to 6 weeks post-operative | Post-operative pulmonary complications between groups |
| Health Services resource usage | Baseline to 12 months post-operative | To compare the burden of health services resource usage between groups (total cost estimate) |
Countries
Canada
Outcome results
None listed