BACKGROUND: The quest for an ideal sealant for dura mater defects persists. The clinical experience with a novel, synthetic self-adhesive patch (TissuePatchDural(®), Tissuemed, Leeds, UK) and its ability to prevent postoperative cerebrospinal fluid (CSF) leakage is described in this article. METHODS: A recently developed, synthetic, self adhesive patch was implanted in 25 patients who underwent intradural neurosurgical procedures. The indication for use was to adjunctively seal dura mater defects. The device is a multi-laminate consisting of thin films of a commonly used structural polymer, poly(lactide-co-glycolide) and a tissue reactive polymer providing fast and strong chemical bonding of the patch with the underlying biological surface. Intraoperative handling and efficacy, biocompatibility, and postoperative observations/follow-up were analysed. Infectious complications, surgical wound features, and postoperative MRI scans were especially reviewed. The mean follow up period was 4.4 months. RESULTS: The device provided fast and efficacious sealing of circumscribed dura mater defects within 1 minute in 23 patients (92%). Two of 25 patients developed a postoperative CSF leakage (8%), which may be secondary to particular factors predisposing these patients to CSF leaks. Surgical handling was straightforward. No infectious complications were recorded; furthermore, wound healing was unremarkable. No clinical evidence of foreign body reactions was observed. In 18 patients, postoperative MRI scans were available which did not show irregularities in any case. CONCLUSIONS: Safe and effective sealing can be accomplished with this bioabsorbable, purely synthetic and thin dural sealant, avoiding the application of foreign biologic material. The product has been shown to be effective in achieving watertight closure of the dura mater and has prevented CSF leakage in 92% of patients treated.
BACKGROUND: The quest for an ideal sealant for dura mater defects persists. The clinical experience with a novel, synthetic self-adhesive patch (TissuePatchDural(®), Tissuemed, Leeds, UK) and its ability to prevent postoperative cerebrospinal fluid (CSF) leakage is described in this article. METHODS: A recently developed, synthetic, self adhesive patch was implanted in 25 patients who underwent intradural neurosurgical procedures. The indication for use was to adjunctively seal dura mater defects. The device is a multi-laminate consisting of thin films of a commonly used structural polymer, poly(lactide-co-glycolide) and a tissue reactive polymer providing fast and strong chemical bonding of the patch with the underlying biological surface. Intraoperative handling and efficacy, biocompatibility, and postoperative observations/follow-up were analysed. Infectious complications, surgical wound features, and postoperative MRI scans were especially reviewed. The mean follow up period was 4.4 months. RESULTS: The device provided fast and efficacious sealing of circumscribed dura mater defects within 1 minute in 23 patients (92%). Two of 25 patients developed a postoperative CSF leakage (8%), which may be secondary to particular factors predisposing these patients to CSF leaks. Surgical handling was straightforward. No infectious complications were recorded; furthermore, wound healing was unremarkable. No clinical evidence of foreign body reactions was observed. In 18 patients, postoperative MRI scans were available which did not show irregularities in any case. CONCLUSIONS: Safe and effective sealing can be accomplished with this bioabsorbable, purely synthetic and thin dural sealant, avoiding the application of foreign biologic material. The product has been shown to be effective in achieving watertight closure of the dura mater and has prevented CSF leakage in 92% of patients treated.