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Crosslinked high amylose starch (CLHAS) matrix was used as a biodegradable drug delivery implant for the prevention and treatment of osteomyelitis. Thirty-two dogs underwent the femoral insertion of a screw inoculated with Staphylococcus aureus and were then randomly assigned to four groups: (A) prevention with ciprofloxacin-CLHAS implants, (B) surgical debridement (positive control), (C) surgical debridement and oral ciprofloxacin treatment and (D) surgical debridement and treatment with ciprofloxacin-CLHAS implants. At week 4 the osteomyelitis was confirmed, the infected site debrided and respective treatments initiated for groups B, C and D. Radiographs, macroscopic evaluations, bacterial cultures and histopathological examinations were used to evaluate the femora at week 10. Femora from preventive group A were almost normal. Dogs of both ciprofloxacin treatment groups C and D showed better bone healing, less periosteal reaction and less screw mobility than dogs from group B. Eradication of infection was observed at proximal/distal sites in B: 25%/12%, C: 37%/62% and D: 62%/75%. Both ciprofloxacin treated groups improved radiographically from week 4 to week 10. Periosteal and marrow neutrophilic and lymphoplasmocytic infiltrations were less severe in groups C and D versus group B. These data suggest that biodegradable ciprofloxacin-CLHAS implants are a safe and efficient modality for the prevention and treatment of osteomyelitis.

The linear, crosslinked amylose-succinate hemostatic agent, IP760, has been evaluated for its interaction with aminoglycosidic antibiotics. The highly structured polymer appears to act as a cationic exchange resin which binds the basic aminoglycosides. Binding of these agents to IP760 is reversed by increased pH and/or increased ionic strength. Dialysis experiments demonstrated that 85 and 90% of the bound gentamicin was released at pH 7.5 and 8.0, respectively, over a period of 36 hr. Formation of the IP760-antibiotic complexes suggests potential medicinal use for hemostatis and slow release of the antibiotic for prophylaxis of postsurgical contamination or infection

Acute and chronic studies were performed in the canine model to evaluate a new topical hemostatic agent in terms of initial hemostatic capability and tissue/material interaction during the healing process. IP760, a porous amylose succinate material, was applied to large splenic surface wounds in six acute and twelve chronic animals. Microfibrillar collagen (Avitene) was used in twelve chronic animals for comparison. While the hemostatic capabilities of the two agents were comparable, marked differences were noted in the healing response. In the IP760-treated wound sites the acute inflammatory response, granulation tissue infiltration with fibrosis and healing occurred earlier and in a more homogeneous manner than in the Avitene-treated wound sites. Healing of the IP760-treated wounds occurred concomitantly with the development of granulation tissue and fibrosis and the rapid resorption of the IP760.

Using a semiquantitative animal model of standardized injuries to parenchymatous organs resulting in a range of degrees of hemorrhage, we compared freeze-dried amylose succinate topical hemostat to the most widely used commercially available products. Hemostatic efficacy parameters included bleeding time, blood loss, incidence of rebleeding, and amount of material used. Although no material was consistently superior in all parameters, in general amylose succinate and microcrystalline collagen performed equally well and both were significantly more effective than oxidized regenerated cellulose. Both amylose succinate and oxidized regenerated cellulose were superior to microcrystalline collagen, however, in biodegradation time, inflammatory response and adhesion-forming potential. Details of the animal model and an adhesion grading scheme are presented.