Effectiveness of BoneSeal® on Bone Hemostats in Patients Undergoing Cardiothoracic Surgery
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|ClinicalTrials.gov Identifier: NCT03085017|
Recruitment Status : Unknown
Verified June 2017 by Nahidh Hasaniya, Loma Linda University.
Recruitment status was: Recruiting
First Posted : March 21, 2017
Last Update Posted : June 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Bypass Grafting||Device: BoneSeal Device: Ostene||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effectiveness of BoneSeal® on Bone Hemostats in Patients Undergoing Cardiothoracic Surgery|
|Actual Study Start Date :||June 7, 2017|
|Estimated Primary Completion Date :||June 7, 2018|
|Estimated Study Completion Date :||August 7, 2018|
|Active Comparator: Ostene||
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.
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.
- Hemostatic Action [ Time Frame: 3-6 hours ]Qualitative determination of bleeding and hemostatic action during application graded by the surgeon using the mild, moderate, and severe for bleeding and complete, moderate, minimal, and failure for hemostatic action.
- Occurrence of Re-bleed [ Time Frame: 3-6 hours ]Occurrence of re-bleeding during the operation will be noted. Reapplication of product will not occur.
- Postoperative hemoglobin [ Time Frame: 3-6 hours ]Postoperative hemoglobin as compared to baseline preoperative readings
- Blood product transfusion quantities [ Time Frame: 3-6 hours ]Intra-operative and post-operative blood product transfusion quantities in total
- Surgical Site Drainage [ Time Frame: 24 hours ]Post-operative chest tube output
- Post Operative Complications [ Time Frame: 30 days ]Sternal wound infection or other complications within 30 days post procedure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03085017
|Contact: Nahidh W Hasaniya, MD, PhDemail@example.com|
|Contact: Vanessa L Ayer Miller, MSfirstname.lastname@example.org|
|Principal Investigator:||Nahidh W Hasaniya, MD, PhD||Loma Linda University|