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

Coronary Artery Bypass Grafting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03085017
• Other study ID #: 5160386
• Secondary ID: 16042
• Status: Completed
• Phase: N/A
• Start date: June 7, 2017
• Est. completion date: November 28, 2017

Study information

• Verified date: May 2021
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: November 28, 2017
• Est. primary completion date: October 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Bypass Grafting

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Loma Linda Medical Center	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View Citation

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

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

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. — View Citation

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. — View Citation

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. — View Citation

Overgaard S, Søballe K, Lind M, Bünger 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Vestergaard RF, Brüel A, Thomsen JS, Hauge EM, Søballe 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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	Hemoglobin	Postoperative hemoglobin as compared to baseline preoperative readings	Pre-operative (baseline) and Post-operative (3-6 hours after baseline)
Primary	Intra-operative Blood Units	Units of blood/blood products transfused during surgery	0-3 hours
Primary	Surgical Site Drainage	Post-operative chest tube output	6, 12, 18 and 24 hours
Primary	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
Primary	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
Primary	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)
Primary	Post-operative Blood Units	Units of blood/blood products transfused within 24 hours post surgery	3-24 hours
Primary	Number of Participants With Infection	The presence of an infection at the sternum at any time up to 30 days post surgery.	30 days