Safety and Efficacy of Tissue-Patch-Dura (TPD) to Reinforce Dural Closure and to Avoid CSF Leaks: A Single-Center Experience

Introduction: Postoperative cerebrospinal fluid (CSF) leak in neurosurgery remains a significant source of morbidity.

Design: Tissue Patch Dura (TPD), a novel impermeable adhesive membrane, can be used to reinforce dural closure in cases considered at high risk to develop postoperative CSF leak.

Methods: A retrospective, single-center, clinical investigation was conducted on 187 patients who were operated on between January and December 2011. Adult patients undergoing clean elective surgeries where a primary watertight closure was not possible were considered. Out of 187 cases, there were 56 skull base approaches. All these patients received TPD to reinforce dural closure. Preoperative (long-term corticosteroid therapy, previous surgery, and radiotherapy), intraoperative (site of procedures and size of dural gap), and postoperative (early and late hydrocephalus) conditions were analyzed as possible risk factors associated with CSF leakage. All patients underwent daily postoperative wound examination, followed by at least one early (within a month) and one late (after 3 months) follow-up visits.

Results: The mean follow-up was 8.46 months (range, 6–12 months). CSF leak was detected in 20 of 187 cases (10.7%) and in 4 out of 56 skull base cases (7.1%). The presence of pre- and postoperative risk factors was associated with a higher percentage of CSF leakage. All leaks could be conservatively treated and no patient required readmission or second surgery. No TPD-related adverse or allergic effects were observed.

Conclusion: TPD confirms preliminary data and proves to be a safe and effective tool in reinforcing dural closure in patients with a high risk of developing CSF leaks.