Coronary Artery Bypass GraftingNCT03085017

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

A study testing BoneSeal and Ostene in people with Coronary Artery Bypass Grafting, run by Loma Linda University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 45 years and older
Conditions the study is for: Coronary Artery Bypass Grafting
What is being tested?: BoneSeal and Ostene
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 57 participants
Where: 1 siteUnited States
Study dates: 7 Jun 2017to 28 Nov 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

An immune system disorder
Known hypersensitivity to components in BoneSeal® or Ostene®
Patients undergoing emergency surgery
Patients undergoing aortic dissection
No consent given

Trial locations and contacts

1 site in 1 country.

United States1 site

Loma Linda Medical Center
Loma Linda, California, 92354

Other trials in United States

About this study

Read the 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.

Conditions: Coronary Artery Bypass Grafting
Being tested: BoneSeal, Ostene

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT03085017
Study group	Role	What they receive
Ostene	Active comparator	Application of Ostene onto cut sternal site for hemostasis. Receives: Device: Ostene
BoneSeal	Experimental	Application of BoneSeal onto cut sternal site for hemostasis. Receives: Device: BoneSeal

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
Measured: 0-3 hours
Hemoglobin
Postoperative hemoglobin as compared to baseline preoperative readings
Measured: Pre-operative (baseline) and Post-operative (3-6 hours after baseline)
Intra-operative Blood Units
Units of blood/blood products transfused during surgery
Measured: 0-3 hours
Surgical Site Drainage
Post-operative chest tube output
Measured: 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
Measured: 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.
Measured: During surgery, up to 3 hours
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
Measured: End of surgery (closure of the chest)
Post-operative Blood Units
Units of blood/blood products transfused within 24 hours post surgery
Measured: 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.
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jun 201728 Nov 2017

First posted21 Mar 2017
Study start7 Jun 2017
Primary completion26 Oct 2017
Study completion28 Nov 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Coronary Artery Bypass GraftingStudies of the same condition, open and under way.
More trials run by Loma Linda UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03085017
Sponsor's protocol ID: 5160386
Other IDs: 16042
Status last verified: May 2021
First submitted: 15 Mar 2017
Last updated: 8 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Light R. Hemostasis in neurosurgery. Journal of neurosurgery. 1945; 2(5): p. 414-34.
Nelson DR, Buxton TB, Luu QN, Rissing JP. The promotional effect of bone wax on experimental Staphylococcus aureus osteomyelitis. J Thorac Cardiovasc Surg. 1990 Jun;99(6):977-80.
PubMed 2359338
Sudmann B, Bang G, Sudmann E. Histologically verified bone wax (beeswax) granuloma after median sternotomy in 17 of 18 autopsy cases. Pathology. 2006 Apr;38(2):138-41. doi: 10.1080/00313020600561732.
PubMed 16581654
Johnson P, Fromm D. Effects of bone wax on bacterial clearance. Surgery. 1981 Feb;89(2):206-9.
PubMed 7006134
Orgill DP, Ehret FW, Regan JF, Glowacki J, Mulliken JB. Polyethylene glycol/microfibrillar collagen composite as a new resorbable hemostatic bone wax. J Biomed Mater Res. 1998 Mar 5;39(3):358-63. doi: 10.1002/(sici)1097-4636(19980305)39:33.0.co;2-i.
PubMed 9468043
Solheim E, Pinholt EM, Andersen R, Bang G, Sudmann E. The effect of a composite of polyorthoester and demineralized bone on the healing of large segmental defects of the radius in rats. J Bone Joint Surg Am. 1992 Dec;74(10):1456-63.
PubMed 1469005
Solheim E, Pinholt EM, Bang G, Sudmann E. Effect of local hemostatics on bone induction in rats: a comparative study of bone wax, fibrin-collagen paste, and bioerodible polyorthoester with and without gentamicin. J Biomed Mater Res. 1992 Jun;26(6):791-800. doi: 10.1002/jbm.820260608.
PubMed 1527101
Sugamori T, Iwase H, Maeda M, Inoue Y, Kurosawa H. Local hemostatic effects of microcrystalline partially deacetylated chitin hydrochloride. J Biomed Mater Res. 2000 Feb;49(2):225-32. doi: 10.1002/(sici)1097-4636(200002)49:23.0.co;2-v.
PubMed 10571909
Wilkinson HA, Baker S, Rosenfeld S. Gelfoam paste in experimental laminectomy and cranial trephination: hemostasis and bone healing. J Neurosurg. 1981 May;54(5):664-7. doi: 10.3171/jns.1981.54.5.0664.
PubMed 7229706
Magyar CE, Aghaloo TL, Atti E, Tetradis S. Ostene, a new alkylene oxide copolymer bone hemostatic material, does not inhibit bone healing. Neurosurgery. 2008 Oct;63(4 Suppl 2):373-8; discussion 378. doi: 10.1227/01.NEU.0000316859.03788.44.
PubMed 18981846
Vestergaard RF, Bruel A, Thomsen JS, Hauge EM, Soballe K, Hasenkam JM. The influence of hemostatic agents on bone healing after sternotomy in a porcine model. Ann Thorac Surg. 2015 Mar;99(3):1005-11. doi: 10.1016/j.athoracsur.2014.10.016. Epub 2015 Jan 16.
PubMed 25601654
Higashi S, Yamamuro T, Nakamura T, Ikada Y, Hyon SH, Jamshidi K. Polymer-hydroxyapatite composites for biodegradable bone fillers. Biomaterials. 1986 May;7(3):183-7. doi: 10.1016/0142-9612(86)90099-2.
PubMed 3013326
Overgaard S, Soballe K, Lind M, Bunger C. Resorption of hydroxyapatite and fluorapatite coatings in man. An experimental study in trabecular bone. J Bone Joint Surg Br. 1997 Jul;79(4):654-9. doi: 10.1302/0301-620x.79b4.7670.
PubMed 9250760

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
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RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
Preoperative Fasting, Pulmonary Aspiration During Anesthetic Induction
Active, not recruiting
Investigation of the Effects of Respiratory Muscle Training Combined With Otago Exercises in Elderly Patients Undergoing Coronary Artery Bypass Graft Surgery
Coronary Artery Bypass Graft (CABG)

All Coronary Artery Bypass Grafting trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of BoneSeal® on Bone Hemostats in Patients Undergoing Cardiothoracic Surgery
ClinicalTrials.gov ID: NCT03085017
Acronym / sponsor ID: 5160386
Conditions: Coronary Artery Bypass Grafting
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: Loma Linda UniversityUniversity, hospital or other
Study start: 7 Jun 2017 (actual)
Primary completion: 26 Oct 2017 (actual)
Study completion: 28 Nov 2017 (actual)
First posted: 21 Mar 2017 (actual)
Results: Posted 22 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Ostene	Active comparator	Device: OsteneApplication of Ostene onto cut sternal site for hemostasis.
BoneSeal	Experimental	Device: BoneSealApplication of BoneSeal onto cut sternal site for hemostasis.

Who may qualify

Ages: 45 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

An immune system disorder
Known hypersensitivity to components in BoneSeal® or Ostene®
Patients undergoing emergency surgery
Patients undergoing aortic dissection
No consent given

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BoneSealBoneSeal® 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	BoneSeal
OsteneOSTENE 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.	Device	Ostene

Primary outcome

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
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.
Hemoglobin
Time frame: Pre-operative (baseline) and Post-operative (3-6 hours after baseline)
Postoperative hemoglobin as compared to baseline preoperative readings
Intra-operative Blood Units
Time frame: 0-3 hours
Units of blood/blood products transfused during surgery
Surgical Site Drainage
Time frame: 6, 12, 18 and 24 hours
Post-operative chest tube output
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
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.
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
Post-operative Blood Units
Time frame: 3-24 hours
Units of blood/blood products transfused within 24 hours post surgery
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.

Results and safety

Results posted to the registry on 22 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ostene	30	30
BoneSeal	27	24

Primary outcome: 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.. Median (Full Range). Unit: units on a scale

Measure	Ostene n = 30	BoneSeal n = 27
Value	4 (1 to 5)	1 (1 to 3)

Population analysed: Subjects undergoing Coronary Artery Bypass Grafting with or without valve replacement repair requiring hemostatic product for cut sternal bone site.

Primary outcome: Number of Participants Experiencing Re-bleed

Time frame: 0-3 hours. Count of participants. Unit: Participants

Measure	Ostene n = 30	BoneSeal n = 27
Value	25	3

Primary outcome: Hemoglobin

Time frame: Pre-operative (baseline) and Post-operative (3-6 hours after baseline). Mean (Standard Deviation). Unit: g/dL

Measure	Ostene n = 30	BoneSeal n = 27
Pre-operative Hemoglobin	12.7 (2.1)	12.7 (2.1)
Post-operative hemoglobin	9.9 (2.0)	10.9 (2.1)

Population analysed: Subjects undergoing Coronary Artery Bypass Grafting, with or without valve replacement or repair and needing hemostatic products be used on cut sternal bone site.

Primary outcome: Intra-operative Blood Units

Time frame: 0-3 hours. Mean (Standard Deviation). Unit: Blood Units

Measure	Ostene n = 30	BoneSeal n = 27
Value	0.50 (0.96)	0.26 (.81)

Adverse events

Time frame: 30 days. Other adverse events reported at 3.33% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ostene	1 of 30 (3.3%)	1 of 30 (3.3%)	0 of 30
BoneSeal	0 of 27 (0%)	0 of 27 (0%)	0 of 27

Limitations and caveats (from the sponsor): This is a small study and a multi-center study is recommended. In spite of randomization the BoneSeal®, group was younger than the Ostene® group.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundLight R. Hemostasis in neurosurgery. Journal of neurosurgery. 1945; 2(5): p. 414-34.
Background: PubMed 2359338Nelson DR, Buxton TB, Luu QN, Rissing JP. The promotional effect of bone wax on experimental Staphylococcus aureus osteomyelitis. J Thorac Cardiovasc Surg. 1990 Jun;99(6):977-80.
Background: PubMed 16581654Sudmann B, Bang G, Sudmann E. Histologically verified bone wax (beeswax) granuloma after median sternotomy in 17 of 18 autopsy cases. Pathology. 2006 Apr;38(2):138-41. doi: 10.1080/00313020600561732.
Background: PubMed 7006134Johnson P, Fromm D. Effects of bone wax on bacterial clearance. Surgery. 1981 Feb;89(2):206-9.
Background: PubMed 9468043Orgill DP, Ehret FW, Regan JF, Glowacki J, Mulliken JB. Polyethylene glycol/microfibrillar collagen composite as a new resorbable hemostatic bone wax. J Biomed Mater Res. 1998 Mar 5;39(3):358-63. doi: 10.1002/(sici)1097-4636(19980305)39:33.0.co;2-i.
Background: PubMed 1469005Solheim E, Pinholt EM, Andersen R, Bang G, Sudmann E. The effect of a composite of polyorthoester and demineralized bone on the healing of large segmental defects of the radius in rats. J Bone Joint Surg Am. 1992 Dec;74(10):1456-63.
Background: PubMed 1527101Solheim E, Pinholt EM, Bang G, Sudmann E. Effect of local hemostatics on bone induction in rats: a comparative study of bone wax, fibrin-collagen paste, and bioerodible polyorthoester with and without gentamicin. J Biomed Mater Res. 1992 Jun;26(6):791-800. doi: 10.1002/jbm.820260608.
Background: PubMed 10571909Sugamori T, Iwase H, Maeda M, Inoue Y, Kurosawa H. Local hemostatic effects of microcrystalline partially deacetylated chitin hydrochloride. J Biomed Mater Res. 2000 Feb;49(2):225-32. doi: 10.1002/(sici)1097-4636(200002)49:23.0.co;2-v.
Background: PubMed 7229706Wilkinson HA, Baker S, Rosenfeld S. Gelfoam paste in experimental laminectomy and cranial trephination: hemostasis and bone healing. J Neurosurg. 1981 May;54(5):664-7. doi: 10.3171/jns.1981.54.5.0664.
Background: PubMed 18981846Magyar CE, Aghaloo TL, Atti E, Tetradis S. Ostene, a new alkylene oxide copolymer bone hemostatic material, does not inhibit bone healing. Neurosurgery. 2008 Oct;63(4 Suppl 2):373-8; discussion 378. doi: 10.1227/01.NEU.0000316859.03788.44.
Background: PubMed 25601654Vestergaard RF, Bruel A, Thomsen JS, Hauge EM, Soballe K, Hasenkam JM. The influence of hemostatic agents on bone healing after sternotomy in a porcine model. Ann Thorac Surg. 2015 Mar;99(3):1005-11. doi: 10.1016/j.athoracsur.2014.10.016. Epub 2015 Jan 16.
Background: PubMed 3013326Higashi S, Yamamuro T, Nakamura T, Ikada Y, Hyon SH, Jamshidi K. Polymer-hydroxyapatite composites for biodegradable bone fillers. Biomaterials. 1986 May;7(3):183-7. doi: 10.1016/0142-9612(86)90099-2.
Individual participant dataSharing planned: No

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Coronary Artery Bypass Graft (CABG)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David G Rabkin, MD, FACS principal investigator

Loma Linda University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing BoneSeal and Ostene in people with Coronary Artery Bypass Grafting, run by Loma Linda University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03085017, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.