Effectiveness of BoneSeal® on Bone Hemostats in Patients Undergoing Cardiothoracic Surgery

Study Overview
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Brief Summary
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A prospective randomized open-label study that will evaluate the effectiveness of the pliable and absorbable bone hemostats (BoneSeal®) on the reduction of bleeding from the sternal bone marrow in patients undergoing cardiothoracic surgery.

Detailed Description
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A prospective randomized open-label study that will evaluate the effectiveness of the pliable and absorbable bone hemostats (BoneSeal®) composed of synthetic materials and hydroxyapatite on the reduction of bleeding from the sternal bone marrow in patients undergoing Coronary Artery Bypass Grafting, with or without valve replacement or repair. This product will be compared to the similar, currently used product, Ostene®. Bleeding will be evaluated qualitatively by the surgeon as well as quantitatively by comparing pre- and post-operative hemoglobin levels, intra-operative and post-operative blood product usage, and post-operative chest tube output. A 30 day follow-up will be conducted to evaluate the patient's tolerance of the product, possible complications, or infection. Additionally, surgeons will be asked to comment on the ease of use of the product.

Official Title
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Effectiveness of BoneSeal® on Bone Hemostats in Patients Undergoing Cardiothoracic Surgery

Conditions
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Coronary Artery Bypass Grafting

Intervention / Treatment
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* Device: BoneSeal
* Device: Ostene


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consent given by patient prior to surgery Adult patients over 45 years Subjects requiring elective, prescheduled or urgent open heart surgery requiring a sternotomy including, but not limited to CABG, valve repair, valve replacement Exclusion Criteria: An immune system disorder Known hypersensitivity to components in BoneSeal® or Ostene® Patients undergoing emergency surgery Patients undergoing aortic dissection No consent given

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ostene<br>Application of Ostene onto cut sternal site for hemostasis. | Device: Ostene<br>* OSTENE is a synthetic, biodissolvable implant material that, provides immediate bone hemostasis, can be used on all bleeding bone surfaces, is completely biocompatible and water-soluble polymer, is a mechanical barrier that does not act biochemically.<br>|
| Experimental: BoneSeal<br>Application of BoneSeal onto cut sternal site for hemostasis. | Device: BoneSeal<br>* BoneSeal® is an absorbable synthetic bone hemostats that also contains of PLA, PEG and hydroxyapatite which supports bone re-growth. Product code MTJ. FDA number K142348.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of Use | Qualitative determination of product application and hemostatic qualities graded by the surgeon using a scale from 1-5 with 1 being very easy and 5 being very difficult | The time frame for assessing the ease of product application is the short interval a the conclusion of the operation when we are applying the topical hemostatic agent to the sternal bone marrow. In other words at the end of the case, this takes <10 min. | 
| Number of Participants Experiencing Re-bleed | Occurrence of re-bleeding during the operation will be noted. Reapplication of product will not occur. | 0-3 hours | 
| Hemoglobin | Postoperative hemoglobin as compared to baseline preoperative readings | Pre-operative (baseline) and Post-operative (3-6 hours after baseline) | 
| Intra-operative Blood Units | Units of blood/blood products transfused during surgery | 0-3 hours | 
| Surgical Site Drainage | Post-operative chest tube output | 6, 12, 18 and 24 hours | 
| Number of Participants With Post Operative Complications Related to the Device | Sternal wound infection or other complications related to the device or its use within 30 days post procedure | 30 days | 
| Number of Participants Requiring Use of Another Product During Surgery | The surgeon's determination and need for the use of another product (FloSeal) during surgery to stop bleeding or re-bleed at the sternum. | During surgery, up to 3 hours | 
| End of Surgery Bleeding | Qualitative determination of of the amount of bleeding at the sternum at the end of surgery by the surgeon using a scale from 1-5 with 1 none and 5 being perfuse | End of surgery (closure of the chest) | 
| Post-operative Blood Units | Units of blood/blood products transfused within 24 hours post surgery | 3-24 hours | 
| Number of Participants With Infection | The presence of an infection at the sternum at any time up to 30 days post surgery. | 30 days |