Trial Outcomes & Findings for Effectiveness of BoneSeal® on Bone Hemostats in Patients Undergoing Cardiothoracic Surgery (NCT NCT03085017)

NCT ID: NCT03085017

Last Updated: 2021-06-08

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 57 participants
• Primary outcome timeframe: 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.
• Results posted on: 2021-06-08

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	30	27
Overall Study COMPLETED	30	24
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Measure	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.	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.
Overall Study Death	0	3

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Ostene n=30 Participants 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.	BoneSeal n=27 Participants 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.	Total n=57 Participants Total of all reporting groups
Age, Continuous	68.9 years STANDARD_DEVIATION 7.7 • n=5 Participants	60.0 years STANDARD_DEVIATION 8.0 • n=7 Participants	64.8 years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	17 Participants n=7 Participants	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants	24 Participants n=7 Participants	48 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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

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

Outcome measures

Measure	Ostene n=30 Participants 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.	BoneSeal n=27 Participants 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.
Ease of Use	4 units on a scale Interval 1.0 to 5.0	1 units on a scale Interval 1.0 to 3.0

PRIMARY outcome

Timeframe: 0-3 hours

Occurrence of re-bleeding during the operation will be noted. Reapplication of product will not occur.

Outcome measures

Measure	Ostene n=30 Participants 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.	BoneSeal n=27 Participants 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.
Number of Participants Experiencing Re-bleed	25 Participants	3 Participants

PRIMARY outcome

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

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

Postoperative hemoglobin as compared to baseline preoperative readings

Outcome measures

Measure	Ostene n=30 Participants 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.	BoneSeal n=27 Participants 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.
Hemoglobin Pre-operative Hemoglobin	12.7 g/dL Standard Deviation 2.1	12.7 g/dL Standard Deviation 2.1
Hemoglobin Post-operative hemoglobin	9.9 g/dL Standard Deviation 2.0	10.9 g/dL Standard Deviation 2.1

PRIMARY outcome

Timeframe: 0-3 hours

Units of blood/blood products transfused during surgery

Outcome measures

Measure	Ostene n=30 Participants 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.	BoneSeal n=27 Participants 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.
Intra-operative Blood Units	0.50 Blood Units Standard Deviation 0.96	0.26 Blood Units Standard Deviation .81

PRIMARY outcome

Timeframe: 6, 12, 18 and 24 hours

Post-operative chest tube output

Outcome measures

Measure	Ostene n=30 Participants 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.	BoneSeal n=27 Participants 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.
Surgical Site Drainage 6 Hour	309.3 mL Standard Deviation 245.1	294.3 mL Standard Deviation 245.1
Surgical Site Drainage 12 Hour	463.7 mL Standard Deviation 338.7	439.3 mL Standard Deviation 338.7
Surgical Site Drainage 18 Hour	598.4 mL Standard Deviation 380.6	568.3 mL Standard Deviation 380.6
Surgical Site Drainage 24 Hour	683.5 mL Standard Deviation 409.5	647.1 mL Standard Deviation 409.5

PRIMARY outcome

Timeframe: 30 days

Sternal wound infection or other complications related to the device or its use within 30 days post procedure

Outcome measures

Measure	Ostene n=30 Participants 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.	BoneSeal n=24 Participants 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.
Number of Participants With Post Operative Complications Related to the Device	2 Participants	0 Participants

PRIMARY outcome

Timeframe: During surgery, up to 3 hours

Population: 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.

The surgeon's determination and need for the use of another product (FloSeal) during surgery to stop bleeding or re-bleed at the sternum.

Outcome measures

Measure	Ostene n=30 Participants 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.	BoneSeal n=27 Participants 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.
Number of Participants Requiring Use of Another Product During Surgery	13 Participants	1 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Ostene n=30 Participants 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.	BoneSeal n=27 Participants 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.
End of Surgery Bleeding	4 units on a scale Interval 1.0 to 5.0	2 units on a scale Interval 1.0 to 3.0

PRIMARY outcome

Timeframe: 3-24 hours

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

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

Outcome measures

Measure	Ostene n=30 Participants 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.	BoneSeal n=27 Participants 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.
Post-operative Blood Units	0.50 Blood Units Standard Deviation 0.96	0.26 Blood Units Standard Deviation 0.81

PRIMARY outcome

Timeframe: 30 days

The presence of an infection at the sternum at any time up to 30 days post surgery.

Outcome measures

Measure	Ostene n=30 Participants 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.	BoneSeal n=24 Participants 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.
Number of Participants With Infection	1 Participants	0 Participants

Adverse Events

Ostene

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

BoneSeal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ostene n=30 participants at risk 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.	BoneSeal n=27 participants at risk 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.
Surgical and medical procedures Infection	3.3% 1/30 • Number of events 1 • 30 days	0.00% 0/27 • 30 days

Other adverse events

Measure	Ostene n=30 participants at risk 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.	BoneSeal n=27 participants at risk 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.
Surgical and medical procedures keloid formation at sternum	3.3% 1/30 • Number of events 1 • 30 days	0.00% 0/27 • 30 days

Additional Information

David G. Rabkin, MD FACS

Loma Linda University Health Care

Phone: 909-558-4354

Email: drabkin@llu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place