A novel impermeable adhesive membrane to reinforce dural closure: a preliminary retrospective study on 119 consecutive high-risk patients.

OBJECTIVE: Postoperative cerebrospinal fluid (CSF) leak in neurosurgery remains a significant source of morbidity. TissuePatchDural (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 119 patients who underwent elective neurosurgical procedures between January and June 2010. Inclusion criteria included adult patients undergoing clean elective surgeries where a primary watertight closure was not possible. Three groups of patients were considered: 1) infratentorial, 67 cases; 2) supratentorial, 34 cases; and 3) spinal, 18 cases. 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.

RESULTS: The mean follow-up was 7.14 months (range 6-12 months). CSF leak was detected in 11 of 119 cases (9.2%). The presence of pre- and postoperative risk factors was associated with a higher percentage of CSF leakage: 8 of 22 cases (36.3%) vs. 3 of 97 cases (3.1%) (P < 0.0001). All leaks could be conservatively treated and no patient required readmission or second surgery. No TPD-related adverse or allergic effects were observed.

CONCLUSIONS: TPD seems to be a safe tool to be used to reinforce dural closure in patients with a high risk of developing CSF leaks.