BoneSeal
BonesSeal

Absorbable Bone Hemostat

BoneSeal® represents a new generation of absorbable bone hemostats. BoneSeal® has been designed with the surgeon in mind as well as the safety of patients.

 

STOPS BLEEDING AND PROMOTES BONE GROWTH

BoneSeal® handles much like bees wax and works immediately to achieve bone hemostasis and will not dissolve. The advanced proprietary formulation of BoneSeal® is based on materials that have a long history of absorbable use and combine a special hydroxyapatite particle intended to help promote bone growth and bone replacement of the traumatized bone.

BoneSeal® absorbable hemostat has the following technical benefits:

• Provides immediate hemostasis
• Best handling when compared to beeswax without the need to warm
• May be used on all bleeding bone surfaces
• Does not crumble like putty


BONESEAL® VS. BEESWAX

Compared to beeswax, BoneSeal® shows substantial absorption and product clearance at 6 weeks and statistically significant formation of new bone (trabecular) as well as new osteoblast formation.*



There are approximately 600,000 to 800,000 sternotomies performed annually. Sternal bleeding is the source of frustration of every cardiac surgeon performing delicate open heart surgeries. For years, beeswax has been the gold standard of hemostatic care for many surgeons in dealing with sternal bleeding. However, it has come to light in the past decade that beeswax can present a host of problems for the patient and healthcare institution. These are the problems that have been identified with beeswax:

• Sternal dehiscence1, 2
• Signficantly impaired healing3
• Granulomas4
• Foreign body reactions5

ATTEMPTS USING ABSORBABLE HEMOSTATIC AGENTS AS STERNAL HEMOSTATS

In recent years, there have been a number of advancements in absorbable, biocompatible materials in the use of hemostatic agents and sealants. The goal of cardiac surgeons has been to attempt to use some of these materials as sternal sealants or hemostatic agents. Many surgeons have tried existing collagen/fibrillar pads or flakes, starch powders or sealants such as bovine thrombin impregnated collagen. None of these has been particularly successful at dealing with sternal bleeding nor have they provided the surgeons with an easy way to apply a hemostat. The surgeons just seem to use them because these are what is available on the shelf.

ATTEMPTS AT ABSORBABLE STERNAL HEMOSATS

There have been several absorbable sternal hemostats introduced to the market place including a hydrophilic PEG hemostat wax and also putty-like sternal hemostat product. Based on our conversations with many cardiac surgeons, the hydrophilic PEG product dissolves quickly which can lead to re-bleeding and re-application, increasing costs. The putty-like compound can tend to crumble and fall off into the surgical field which can lead to risks associated with foreign body intrusion into valve procedures. Needless to say, these products have not gained much traction in the market.

THE GOAL - THE IDEAL STERNAL SEALANT/HEMOSTAT

The primary goal of any sternal hemostat is to number one; apply like beeswax and have the consistency and handling characteristics of beeswax. Second, sternal bleeding should cease immediately upon application (without having to make special preparations or having to wait for a hemostat to set up), saving the cardiac or thoracic surgeon and staff, valuable time. Third, the ideal property of such a product would be able that it is absorbable and aids in the healing of the sternum.

THE SOLUTION

BoneSeal® has been developed to be the world’s first absorbable sternal hemostat sealant with the application properties and effectiveness of beeswax. BoneSeal® contains two proprietary absorbable polymers (PEG and PLA) and is fully absorbable. At the same time, BoneSeal® also contains hydroxyapatite intended to act as a scaffold to help aid in the natural healing process. Hydroxyapatite is well known for its properties as a bone growth scaffold and how it helps in new bone formation, marrow and osteoblasts6,7. In a recently published Abstract from a biomaterials journal Poster Presentation, BoneSeal® demonstrated better healing, bone re-growth, osteoblast formation, less fibrous material and better absorption than beeswax8.

FOOTNOTES
1. Kardiochir Torakochirurgia Pol. 2014 Dec; 11(4): 385–390. Published online 2014 Nov 30.
2. https://www.researchgate.net/publication/276304243...
3. https://cardiothoracicsurgery.biomedcentral.com/articles/10.1186/1749-8090-5-117
4. https://www.ncbi.nlm.nih.gov/pubmed/16581654 Histologically verified bone wax (beeswax) granuloma after median sternotomy in 17 of 18 autopsy cases. Pathology Volume 38, Issue 2, April 2006, Pages 138-141. Bone wax as a cause of a foreign body granuloma in a resternotomy : a case report. Journal of Cardiothoracic Surgery20138(Suppl 1):P121. DOI: 10.1186/1749-8090-8-S1-P121.  Ozerdem
5. Bone wax as a cause of a foreign body granuloma in a resternotomy : a case report. Journal of Cardiothoracic Surgery20138(Suppl 1):P121. DOI: 10.1186/1749-8090-8-S1-P121.  Ozerdem
6. Bone Regeneration in Osseous Defects Using Hydroxyapatite Graft and the Extent of Ossification in Osseous Defects Treated Without Grafts: A Comparative EvaluationJ Maxillofac Oral Surg. 2011 Jun; 10(2): 123–126. Published online 2011 Apr 22. doi:  10.1007/s12663-011-0189-x
7. http://jms.org.br/PDF/v20n1a08.pdf
8. Analysis of Bone Healing in a Novel Bone Wax Substitute Compared to Bone Wax in a Porcine Bone Defect Model

*Tham T, Costantino PD, Roberts K, Shanahan J, Burban J. Analysis of a Novel Bone Wax Substitute Compared to Bone Wax in the 6 Week Porcine Bone Defect Model. Institute of Biological Engineering Annual Meeting, Greenville, South Carolina, USA. 9th April, 2016