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| Name | Class |
|---|---|
| Abyrx, Inc. | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Montage bone putty | Experimental | Sternal closure with conventional wire cerclage plus Montage bone putty |
|
| Conventional Sternal Closure | Active Comparator | Conventional wire cerclage sternal closure only -- standard care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Montage bone putty | Device | Application of bone putty on cut sternal surfaces prior to application of conventional wires for closure of sternum during cardiac surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Radiographic Sternal Integrity | No radiographic evidence of bony instability as assessed through serial chest x-rays | Intervention to 12 months post-operative |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Rate of post-operative recovery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul WM Fedak, MD, PhD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | T2N 2T9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36272766 | Derived | Vasanthan V, Fatehi Hassanabad A, Kang S, Dundas J, Ramadan D, Holloway D, Adams C, Ahsan M, Fedak PWM. Novel hardening bone putty enhances sternal closure and accelerates postoperative recovery. J Thorac Cardiovasc Surg. 2023 Nov;166(5):e430-e443. doi: 10.1016/j.jtcvs.2022.09.016. Epub 2022 Sep 17. |
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Randomized, single centre, double-blind clinical study
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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.
| Conventional Sternal Closure | Other | Closure of sternum with standard wire cerclage. |
|
Rate of post-operative recovery as measured by health related quality of life (EQ5D) standardized assessment tool
| Baseline to 12 months post-operative |
| 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 |
| Sternal Wound Infections | Frequency of sternal wound infections (superficial and deep) between groups | Baseline to 12 months post-operative |
| Pulmonary Complications | Post-operative pulmonary complications between groups | Baseline to 6 weeks post-operative |
| Health Services resource usage | To compare the burden of health services resource usage between groups (total cost estimate) | Baseline to 12 months post-operative |