Effectiveness and handling characteristics of a three-layer polymer dura substitute: a prospective multicenter clinical study

Object The goal of this study was to assess the effectiveness and handling characteristics of a dura substitute composed of two outer layers of expanded polytetrafluoroethylene (PTFE) and a middle layer consisting of an elastomeric fluoropolymer. Methods In a prospective multicenter study, the dura substitute was implanted using a standard technique in 119 patients undergoing cranial or spinal surgery requiring duraplasty. Intraoperative assessments of the dura patch consisted of testing for cerebrospinal fluid (CSF) leakage employing the Valsalva maneuver and a surgeon’s standard evaluation of the handling characteristics of the device. Postoperative assessments conducted during a mean follow-up time of 15.7 months (range 0.3–45.6 months) consisted of physical examinations, routine computed tomography (CT) or magnetic resonance (MR) imaging studies, and histological studies of any removed dura patches. The mean age of the 119 patients was 40 years (range < 1–81 years). The dura substitute was implanted c...