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

NCT03085017 | Completed Results FDA Device

• 2 other identifiers: 516038616042
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (10)

• 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

  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.

  0-3 hours

• Hemoglobin

  Postoperative hemoglobin as compared to baseline preoperative readings

  Pre-operative (baseline) and Post-operative (3-6 hours after baseline)

• Intra-operative Blood Units

  Units of blood/blood products transfused during surgery

  0-3 hours

• Surgical Site Drainage

  Post-operative chest tube output

  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

  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.

  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

  End of surgery (closure of the chest)

• Post-operative Blood Units

  Units of blood/blood products transfused within 24 hours post surgery

  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.

  30 days

Study Arms (2)

Ostene

ACTIVE COMPARATOR

Application of Ostene onto cut sternal site for hemostasis.

Device: Ostene

BoneSeal

EXPERIMENTAL

Application of BoneSeal onto cut sternal site for hemostasis.

Device: BoneSeal

Interventions

BoneSeal DEVICE

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.

BoneSeal

Ostene DEVICE

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.

Ostene

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda Medical Center

Loma Linda, California, 92354, United States

Location

Related Publications (13)

• Light R. Hemostasis in neurosurgery. Journal of neurosurgery. 1945; 2(5): p. 414-34.

  BACKGROUND

• 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.

  PMID: 2359338 BACKGROUND

• 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.

  PMID: 16581654 BACKGROUND

• Johnson P, Fromm D. Effects of bone wax on bacterial clearance. Surgery. 1981 Feb;89(2):206-9.

  PMID: 7006134 BACKGROUND

• 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.

  PMID: 9468043 BACKGROUND

• 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.

  PMID: 1469005 BACKGROUND

• 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.

  PMID: 1527101 BACKGROUND

• 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.

  PMID: 10571909 BACKGROUND

• 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.

  PMID: 7229706 BACKGROUND

• 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.

  PMID: 18981846 BACKGROUND

• 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.

  PMID: 25601654 BACKGROUND

• 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.

  PMID: 3013326 BACKGROUND

• 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.

  PMID: 9250760 BACKGROUND

Limitations and Caveats

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.

Results Point of Contact

• Title: David G. Rabkin, MD FACS
• Organization: Loma Linda University Health Care

drabkin@llu.edu

909-558-4354

Study Officials

• David G Rabkin, MD, FACS

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: March 21, 2017
• Study Start: June 7, 2017
• Primary Completion: October 26, 2017
• Study Completion: November 28, 2017
• Last Updated: June 8, 2021
• Results First Posted: September 22, 2020

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)