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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
57
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.
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.
Loma Linda Medical Center
Loma Linda, California, United States
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
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.
Number of Participants Experiencing Re-bleed
Occurrence of re-bleeding during the operation will be noted. Reapplication of product will not occur.
Time frame: 0-3 hours
Hemoglobin
Postoperative hemoglobin as compared to baseline preoperative readings
Time frame: Pre-operative (baseline) and Post-operative (3-6 hours after baseline)
Intra-operative Blood Units
Units of blood/blood products transfused during surgery
Time frame: 0-3 hours
Surgical Site Drainage
Post-operative chest tube output
Time frame: 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
Time frame: 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.
Time frame: During surgery, up to 3 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Time frame: End of surgery (closure of the chest)
Post-operative Blood Units
Units of blood/blood products transfused within 24 hours post surgery
Time frame: 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.
Time frame: 30 days