Clinical application of a physically and chemically processed human substitute for dura mater.

Object: Allogenic human fascia lata used in neurosurgery as a dura mater substitute can be associated with the risk of virus and bacterium transmission and with a delay in its incorporation due to immunological and inflammatory reactions. The authors review their preliminary experience with a chemically and physically processed fascia lata graft.
Methods: Grafts that had been treated with solvent detergents, freeze-dried for conservation, and gamma irradiated (25,000 Gy) for sterilization were placed into 17 patients during neurosurgical procedures performed to treat brain tumors, cerebral malformations, trigeminal neuralgia, and posttraumatic lesions. The handling properties of the material, surgical wound features, and hematological parameters were evaluated. The average follow-up period was 23.8 +/- 2.2 months (mean +/- standard deviation). The handling properties and biocompatibility of these human dural substitutes were highly satisfactory and no major complications were observed. Postoperative computerized tomography or magnetic resonance images obtained in 13 patients revealed no abnormal findings at the site of fascia lata implantation. In one patient who underwent a second surgery performed 12 months after the initial operation, this dural substitute was found to have been recolonized by host fibroblastic cells and replaced by autologous collagenous tissue.
Conclusions: Human fascia lata that has been rendered safe by applying physical and chemical treatment is a fully biocompatible alternative to the dural graft materials currently available.