Hemostatic efficacy of a novel Ca/P/S-based bone graft material and its preliminary clinical evidence in sternum

Jun-Neng Roan1, Pao-Yen Lin1, Jiin-Huey Chern Lin2,3,4

  • 1Division of Cardiovascular Surgery, Department of Surgery, National Cheng-Kung University Hospital, College of Medicine, National Cheng-Kung University, Tainan, Taiwan.

Insights

A new synthetic bone graft substitute, Ezechbone® Granule CBS-400, effectively controlled bleeding and promoted sternal healing in cardiac surgery patients. This biomaterial shows promise for improving surgical outcomes and bone regeneration.

Area of Science:

  • Biomaterials Science
  • Surgical Innovation
  • Orthopedic Research

Background:

  • Median sternotomy, standard in cardiac surgery, often causes significant marrow bleeding and delayed healing, especially in vulnerable patients.
  • Existing hemostatic agents can control bleeding but may hinder bone regeneration, creating a need for advanced solutions.
  • Ezechbone® Granule CBS-400 is a novel synthetic calcium/phosphorus/sulfur-based bone graft substitute designed to address these challenges.

Purpose of the Study:

  • To evaluate the hemostatic and osteoregenerative properties of Ezechbone® Granule CBS-400.
  • To compare CBS-400 with conventional calcium-based hemostatic products.
  • To assess the clinical efficacy of CBS-400 in high-risk cardiac surgery patients undergoing sternotomy.

Main Methods:

  • In vitro blood clotting assays to determine clotting index.
  • In vivo rat tibial implantation studies to assess clot stability and biocompatibility.
  • Clinical pilot study in sternotomy patients measuring chest tube drainage, duration, and sternal healing.

Main Results:

  • CBS-400 demonstrated rapid clot formation with the lowest blood clotting index in vitro.
  • In vivo studies showed superior clot stability and reduced inflammation compared to controls.
  • Clinical use resulted in reduced chest tube drainage, shorter drainage duration, and decreased ICU stays, alongside stable sternal healing.

Conclusions:

  • Ezechbone® Granule CBS-400 exhibits combined hemostatic and osteoregenerative capabilities.
  • This multifunctional biomaterial shows potential for improving outcomes in complex surgical settings like sternotomy.
  • Further randomized clinical trials are recommended to validate findings and establish optimal usage protocols.

Related Concept Videos