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LT Muller, DS Gombos, CK Mishra, CA Gunderson, CJ Calvano; Biocompatability Studies of a Novel Biomaterial for Ocular Surface Reconstruction . Invest. Ophthalmol. Vis. Sci. 2002;43(13):1110.
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Purpose: Reconstructive surgeons have long sought a material which possess a good tensile strength, is biocompatable and poses a low risk of promoting infection from donor to host. We present an initial biocompatability study of porcine intestinal submucosa grafted onto the ocular surface of rabbits. Methods: After receiving protocol approval from the UTMB IACUC, six adult female New Zealand White rabbits were divided into three groups: control, sham and graft. The rabbits were anesthetized with ketamine and xylezine, prepped and draped in a sterile fashion. A superior incision was made through the conjunctiva and tenons. In the graft group, a 5mm x 5 mm graft was sewn onto the sclera using interrupted 6-0 vicryl sutures and then the conjunctiva was closed. The sham rabbits underwent the same superior incision and closure, but without suturing a graft to the sclera. The control eyes were not operated upon. All groups received a single dose of maxitrol ointment post operatively. The rabbits were sacrificed at twelve weeks, and gross and microscopic pathology evaluations were performed. Results: All animals tolerated the procedure well. There were no infections, no graph sloughing or rejection. At harvest time, the tissue sites were grossly normal with no evidence of suture material or graft-host interface changes. Histology revealed architectural organizations consistent with conjunctiva and tenons overlying the graft matrix. Conclusion: In rabbits, this material is well tolerated for surface reconstruction. A single dose of steroid/antibiotics at the time of surgery was an effective prophylaxis against infection. Porcine submucosa is a novel biomaterial with a variety of potential clinical applications in the field of ophthalmology. It is surgically robust, well tolerated on the ocular surface and does not incur the risk of viral transmission associated with human derived tissue. Further studies are needed to further elucidate the clinical utility of this material.
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