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

NCT03085017 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2021-06-08

Study results available
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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.

Conditions

  • Coronary Artery Bypass Grafting

Interventions

DEVICE

BoneSeal

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.

DEVICE

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.

Sponsors & Collaborators

  • Loma Linda University

    lead OTHER

Principal Investigators

  • David G Rabkin, MD, FACS · Loma Linda University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-07
Primary Completion
2017-10-26
Completion
2017-11-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03085017 on ClinicalTrials.gov