Examination of the safety and efficacy of an absorbable dura mater substitute (Dura Patch®) in normal applications in neurosurgery

BACKGROUND The possibility of the transmission of Creutzfeldt-Jakob disease and slow virus infection (HIV) by cadaveric dura implants makes it necessary to find synthetic, absorbable substitute materials for plastic reconstruction of the dura mater. Dura-Patch is a bilayered composite of a dyed polydioxanone (PDS(R)) foil and an undyed fleece of Polyglactin 910 (Vicryl(R)) and PDS threads, known to be completely resorbable. METHODS The Dura-Patch(R) was tested prospectively in 101 patients undergoing 75 supratentorial, 20 infratentorial, and 6 spinal operations in seven different neurosurgical departments. Fixation of the substitute was either by suturing, glueing, or both. The specific tissue properties were investigated considering biocompatibility, form, size, adaptability, fixation, scarring, and resistance to CSF tearing with the aid of hematologic and neurological parameters, CCT, and/or MRI scanning up to 6 months postoperatively. RESULTS A total of 76 of 101 patients completed the study (75%). The biocompatibility of the Dura-Patch(R) with timely absorption of the implant material was excellent without exception. There was no notable local scarring and no infections. Transient CSF cushioning in 12.9% of the patients was in keeping with the normal range, The elasticity and flexibility of the Dura-Patch(R) was rated as "good" in 90% and was still better when the size of the implant increased, with an overall rating of handling as "good" or "excellent" in 97% of all operations, CONCLUSIONS The new absorbable Dura-Patch showed itself to be suitable for both plastic dura reconstruction and plastic extension of the subdural space with primary, watertight, germproof closure in routine intracranial and spinal tumor removal. (C) 1999 by Elsevier Science Inc.