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

May 13, 2021 updated by: Loma Linda University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Consent given by patient prior to surgery
  2. Adult patients over 45 years
  3. Subjects requiring elective, prescheduled or urgent open heart surgery requiring a sternotomy including, but not limited to CABG, valve repair, valve replacement

Exclusion Criteria:

  1. An immune system disorder
  2. Known hypersensitivity to components in BoneSeal® or Ostene®
  3. Patients undergoing emergency surgery
  4. Patients undergoing aortic dissection
  5. No consent given

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ostene
Application of Ostene onto cut sternal site for hemostasis.
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.
Experimental: BoneSeal
Application of BoneSeal onto cut sternal site for hemostasis.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: 0-3 hours
Occurrence of re-bleeding during the operation will be noted. Reapplication of product will not occur.
0-3 hours
Hemoglobin
Time Frame: Pre-operative (baseline) and Post-operative (3-6 hours after baseline)
Postoperative hemoglobin as compared to baseline preoperative readings
Pre-operative (baseline) and Post-operative (3-6 hours after baseline)
Intra-operative Blood Units
Time Frame: 0-3 hours
Units of blood/blood products transfused during surgery
0-3 hours
Surgical Site Drainage
Time Frame: 6, 12, 18 and 24 hours
Post-operative chest tube output
6, 12, 18 and 24 hours
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
30 days
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.
During surgery, up to 3 hours
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
End of surgery (closure of the chest)
Post-operative Blood Units
Time Frame: 3-24 hours
Units of blood/blood products transfused within 24 hours post surgery
3-24 hours
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.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Investigators

  • Principal Investigator: David G Rabkin, MD, FACS, Loma Linda University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2017

Primary Completion (Actual)

October 26, 2017

Study Completion (Actual)

November 28, 2017

Study Registration Dates

First Submitted

March 15, 2017

First Submitted That Met QC Criteria

March 15, 2017

First Posted (Actual)

March 21, 2017

Study Record Updates

Last Update Posted (Actual)

June 8, 2021

Last Update Submitted That Met QC Criteria

May 13, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 5160386
  • 16042 (Other Identifier: Loma Linda Clinial Trials Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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