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| ID | Type | Description | Link |
|---|---|---|---|
| 16042 | Other Identifier | Loma Linda Clinial Trials Center |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ostene | Active Comparator | Application of Ostene onto cut sternal site for hemostasis. |
|
| BoneSeal | Experimental | Application of BoneSeal onto cut sternal site for hemostasis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David G Rabkin, MD, FACS | Loma Linda University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda Medical Center | Loma Linda | California | 92354 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Light R. Hemostasis in neurosurgery. Journal of neurosurgery. 1945; 2(5): p. 414-34. | ||
| 2359338 | 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. | |
| 16581654 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ostene | 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. |
| FG001 | BoneSeal | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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30 subjects had Ostene applied on cut sternal bone site. 27 subjects had BoneSeal applied on cut sternal bone site.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ostene | 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. |
| BG001 | BoneSeal |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Subjects undergoing Coronary Artery Bypass Grafting with or without valve replacement repair requiring hemostatic product for cut sternal bone site. | Posted | Median | Full Range | units on a scale | 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. |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ostene | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Surgical and medical procedures | Systematic Assessment | Deep sternal wound infection. There were no adverse events in the BoneSeal group. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| keloid formation at sternum | Surgical and medical procedures | Non-systematic Assessment | keloid formation at sternum |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David G. Rabkin, MD FACS | Loma Linda University Health Care | 909-558-4354 | drabkin@llu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 28, 2016 | May 13, 2021 | Prot_SAP_001.pdf |
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| 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. |
|
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 |
| 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. |
| 7006134 | Background | Johnson P, Fromm D. Effects of bone wax on bacterial clearance. Surgery. 1981 Feb;89(2):206-9. |
| 9468043 | 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. |
| 1469005 | 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. |
| 1527101 | 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. |
| 10571909 | 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. |
| 7229706 | 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. |
| 18981846 | 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. |
| 25601654 | 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. |
| 3013326 | 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. |
| 9250760 | 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. |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | BoneSeal | 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. |
|
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| Primary | Number of Participants Experiencing Re-bleed | Occurrence of re-bleeding during the operation will be noted. Reapplication of product will not occur. | Posted | Count of Participants | Participants | 0-3 hours |
|
|
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| Primary | Hemoglobin | Postoperative hemoglobin as compared to baseline preoperative readings | Subjects undergoing Coronary Artery Bypass Grafting, with or without valve replacement or repair and needing hemostatic products be used on cut sternal bone site. | Posted | Mean | Standard Deviation | g/dL | Pre-operative (baseline) and Post-operative (3-6 hours after baseline) |
|
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| Primary | Intra-operative Blood Units | Units of blood/blood products transfused during surgery | Posted | Mean | Standard Deviation | Blood Units | 0-3 hours |
|
|
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| Primary | Surgical Site Drainage | Post-operative chest tube output | Posted | Mean | Standard Deviation | mL | 6, 12, 18 and 24 hours |
|
|
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| 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 | Posted | Count of Participants | Participants | 30 days |
|
|
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| 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. | Subjects undergoing Coronary Artery Bypass Grafting, with or without valve replacement or repair and in need of a hemostatic agent be applied on cut sternal bone site. | Posted | Count of Participants | Participants | 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 | Posted | Median | Full Range | units on a scale | End of surgery (closure of the chest) |
|
|
|
| Primary | Post-operative Blood Units | Units of blood/blood products transfused within 24 hours post surgery | Subjects undergoing Coronary Artery Bypass Grafting, with or without valve replacement or repair and needing hemostatic products be used on cut sternal bone site. | Posted | Mean | Standard Deviation | Blood Units | 3-24 hours |
|
|
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| Primary | Number of Participants With Infection | The presence of an infection at the sternum at any time up to 30 days post surgery. | Posted | Count of Participants | Participants | 30 days |
|
|
|
| 0 |
| 30 |
| 1 |
| 30 |
| 1 |
| 30 |
| EG001 | BoneSeal | 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. | 0 | 27 | 0 | 27 | 0 | 27 |
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| 18 Hour |
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| 24 Hour |
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