Effectiveness of BoneSeal® on Bone Hemostats in Patients Undergoing Cardiothoracic Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Loma Linda University
- Enrollment
- 57
- Locations
- 2
- Primary Endpoint
- Ease of Use
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Ease of Use
Time Frame: 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.
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
Number of Participants Experiencing Re-bleed
Time Frame: 0-3 hours
Occurrence of re-bleeding during the operation will be noted. Reapplication of product will not occur.
Surgical Site Drainage
Time Frame: 6, 12, 18 and 24 hours
Post-operative chest tube output
Hemoglobin
Time Frame: Pre-operative (baseline) and Post-operative (3-6 hours after baseline)
Postoperative hemoglobin as compared to baseline preoperative readings
Number of Participants Requiring Use of Another Product During Surgery
Time Frame: During surgery, up to 3 hours
The surgeon's determination and need for the use of another product (FloSeal) during surgery to stop bleeding or re-bleed at the sternum.
Intra-operative Blood Units
Time Frame: 0-3 hours
Units of blood/blood products transfused during surgery
Post-operative Blood Units
Time Frame: 3-24 hours
Units of blood/blood products transfused within 24 hours post surgery
Number of Participants With Post Operative Complications Related to the Device
Time Frame: 30 days
Sternal wound infection or other complications related to the device or its use within 30 days post procedure
End of Surgery Bleeding
Time Frame: End of surgery (closure of the chest)
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
Number of Participants With Infection
Time Frame: 30 days
The presence of an infection at the sternum at any time up to 30 days post surgery.
Secondary Outcomes
No secondary outcomes reported