CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 57 enrolled
Drug / intervention
BoneSeal +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03085017
NCT03085017N/ACompleted
CompareCT.gov

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

Loma Linda University·interventional·Posted Mar 21, 2017·Updated Jun 8, 2021

In Brief

A clinical study evaluating BoneSeal and Ostene for Coronary Artery Bypass Grafting. Completed, enrolled 57 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Bypass Grafting
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMar 21, 2017
Enrollment StartJun 7, 2017
Primary CompletionOct 26, 2017
Study CompletionNov 28, 2017
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 9.3 years ago

Interventions

BoneSealdevice

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.

Ostenedevice

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.