Development of a Moldable, Biodegradable Polymeric Bone Repair Material

After the revision of the statement of work, the objective of this contract was the development of a biodegradable bone wax. It would be used as a hemostatic agent for bone surfaces. Degradation of this material would lessen the interference with bone repair and other complications seen with Ethicon Bone Wax which is considered minimally resorbable. Low molecular weight polycaprolactone PCL was combined with a range of biocompatible additives to prepare formulations with handling similar to Ethicon Bone Wax. Several were found to be effective hemostatic agents in animal trials. Manufacturing and quality control procedures were developed for three formulations 79 PCL with 21 polyethylene glycol, 85 PCL with 15 calcium carbonate, and 77 PCL with 23 polyvinyl alcohol. These were compared to Ethicon Bone Wax and untreated controls in a 12 weeks study. The hemostatic performance of all test formulations were comparable to that of Ethicon Bone Wax. All test formulations were more biocompatible than Ethicon Bone Wax. None of the formulations were completely degraded at 12 weeks. The formulation containing polyethylene glycol was associated with the mildest foreign body response plus the most advanced defect healing and degradation. Bone wax, Biodegradable, Biomaterial hemostatic.