A comparative study of the biologic and immunologic response to medical devices derived from dermal collagen.
We examined collagen materials for soft tissue augmentation [Zyderm Collagen Implant (ZCI), glutaraldehyde cross-linked (GAX) collagen, and Koken Atelocollagen (Atelocollagen)]; hemostatic collagens [Gelfoam Gelatin Powder (Gelfoam), Avitene Microfibrillar Collagen Hemostat (Avitene), and Collastat Collagen Hemostat (Collastat)]; and reconstituted, intact fibrillar collagen from bovine skin in a subcutaneous guinea pig model. After 11, 25, and 39 days in situ, explants from animals injected with GAX collagen demonstrated greater wet-weight persistence than all other materials. Conversely, at all time points, the explants of Atelocollagen were the least persistent. Following 25 days in vivo, explants were examined using differential scanning calorimetry; ZCI and Atelocollagen displayed thermal transition temperatures of 58 degrees C. Avitene and Gelfoam explants displayed transition points of 30 degrees C and 32 degrees C, indicating denatured or cleaved collagen. By contrast, GAX collagen explants had a high (68 degrees C) transition temperature, reflecting its cross-linking. With respect to immunogenicity, day 39 sera from ZCI treated animals showed significantly lower titers in the ELISA to their respective implant collagen than all other groups examined, while antibody activity in the GAX collagen, Gelfoam, Atelocollagen, and intact collagen groups were not significantly different. Collastat elicited antibodies with a greater affinity than observed in these previous groups. Sera from Avitene treated animals demonstrated the highest antibody levels and were the only sera which reacted with bovine serum albumin. Thus, Avitene was the most immunogenic of the collagen materials examined, while GAX collagen demonstrated the greatest persistence and minimal immunogenicity, and ZCI was the least immunogenic.
D000818:Animals; D000917:Antibody Formation / Q000187:drug effects; D000941:Antigens / Q000276:immunology; D001672:Biocompatible Materials / Q000633:toxicity*; D002152:Calorimetry, Differential Scanning; D002417:Cattle; D003094:Collagen / Q000276:immunology / Q000633:toxicity*; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006168:Guinea Pigs; D019736:Prostheses and Implants; D011489:Protein Denaturation; D012710:Serum Albumin, Bovine / Q000276:immunology; D013997:Time Factors
D000941:Antigens; D001672:Biocompatible Materials; D012710:Serum Albumin, Bovine; D003094:Collagen