Efficacy of a synthetic collagen-based sealant (TachoSil(®)) in preventing cerebrospinal fluid leak following planned and incidental durotomies in spine surgery: a retrospective cohort study

合成胶原蛋白基密封剂(TachoSil®)在预防脊柱手术中计划内和意外硬膜切开术后脑脊液漏方面的疗效:一项回顾性队列研究

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Abstract

Cerebrospinal fluid (CSF) leakage is a significant complication following planned or incidental durotomies during spinal surgery. While primary suturing remains the gold standard for dural closure, it is common to necessitate adjunctive reinforcement techniques. This study aims to evaluate the efficacy of a synthetic collagen-based sealant patch (TachoSil(®)) in preventing CSF leaks in a large cohort of patients undergoing spinal surgery. A retrospective analysis was conducted in whom TachoSil(®) was used as a dural sealant, either following planned (n = 12) or incidental (n = 42) durotomies, or prophylactically (n = 31) after decompression for critical lumbar canal stenosis. The primary endpoint was the prevention and resolution rate of CSF leaks. Secondary endpoints included reoperation rates and postoperative complications. A total of 85 patients (6.8%) met the inclusion criteria (mean age, 64.7 ± 15.4 years). TachoSil® was used as monotherapy in 39 patients and in combination with primary suturing or other sealants in 46 patients. Overall, 66 patients (77.6%) did not require surgical reintervention. TachoSil® monotherapy was associated with a significantly higher success rate (89.7%) compared to combined techniques (68.2% for TachoSil® plus suturing and 60.0% for TachoSil® plus other sealants; p = 0.041). Excluding its prophylactic use (either planned or incidental durotomy, n = 54), its efficacy in avoiding reintervention was 86.7% for TachoSil® alone, 77.3% for TachoSil® plus suture, and 64.7% for TachoSil® plus other combinations of sealants (p = 0.67). Postoperative complications occurred in 22 patients (25.9%), primarily including persistent CSF fistula, pseudomeningocele formation, and surgical site infections. TachoSil® demonstrated high efficacy as a standalone dural reinforcement method and when combined with suture or other sealant techniques in preventing CSF leaks following spinal surgeries involving dural compromise.

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