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NCT Number: NCT03085017

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

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.

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Key information

Conditions

Coronary Artery Bypass Grafting

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda Medical Center

Loma Linda, California, 92354, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Ease of Use

    Time frame: 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.

    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

  2. Number of Participants Experiencing Re-bleed

    Time frame: 0-3 hours

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

  3. Hemoglobin

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

    Postoperative hemoglobin as compared to baseline preoperative readings

  4. Intra-operative Blood Units

    Time frame: 0-3 hours

    Units of blood/blood products transfused during surgery

  5. Surgical Site Drainage

    Time frame: 6, 12, 18 and 24 hours

    Post-operative chest tube output

  6. Number of Participants With Post Operative Complications Related to the Device

    Time frame: 30 days

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

  7. Number of Participants Requiring Use of Another Product During Surgery

    Time frame: During surgery, up to 3 hours

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

  8. End of Surgery Bleeding

    Time frame: 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

  9. Post-operative Blood Units

    Time frame: 3-24 hours

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

  10. Number of Participants With Infection

    Time frame: 30 days

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

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 21, 2017
Registry last updated
Jun 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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