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Fibrin Glue-Coated Collagen Complex Patch: A Novel Material for Surgical Repair of Spontaneous Temporal Bone Cerebrospinal Fluid Leak and Encephalocele.
Otology & Neurotology 2023 March 25
OBJECTIVE: To compare outcomes of surgical repair of temporal bone encephalocele and cerebrospinal fluid (CSF) leak using fibrin glue-coated collagen (FGCC) complex patch versus other materials for repair of dura.
STUDY DESIGN: Retrospective chart review.
SETTING: Tertiary care hospital.
PATIENTS: Fifty-two adult patients undergoing transmastoid (TM), middle fossa (MF) or combined approach repair of spontaneous MF CSF leak between 2016 and 2020.
INTERVENTIONS: Exposure of bony defect via TM approach, MF craniotomy, or combined TM/MF, and repair of the associated dura defect with FGCC complex patch, or other materials (acellular collagen matrix, bovine collagen, autologous fascia, fibrin tissue sealant).
MAIN OUTCOME MEASURES: Successful repair without recurrent CSF leak or encephalocele throughout follow-up. Cost of materials used in duraplasty.
RESULTS: Sixty-four percent of patients were female. Mean (standard deviation) age at repair was 61.4 (12.1) years. Mean (standard deviation) body mass index was 35.0 (8.3) kg/m2. Forty-nine (94%) patients had successful repair without known recurrence of CSF leak or encephalocele over a median follow-up interval of 11.7 months. Average duraplasty material cost was significantly lower with FGCC in comparison with other nonautologous materials (FGCC+: $1259.94, FGCC-: $1652.58; p = 0.004). No significant differences in recurrence risk (FGCC+: 6.9%, FGCC-: 6.9%; p > 0.999) or operative time (FGCC+: 153.7 min, FGCC-: 155.4 min; p = 0.88) were detected based on material used for duraplasty.
CONCLUSIONS: All materials studied demonstrate effective and sustained means of repair for MF CSF leak and encephalocele, including in the presence of multiple defects. Use of FGCC for duraplasty produces noninferior surgical results to other nonautologous materials in repair of spontaneous CSF leaks of the temporal bone and may be more cost-effective.
STUDY DESIGN: Retrospective chart review.
SETTING: Tertiary care hospital.
PATIENTS: Fifty-two adult patients undergoing transmastoid (TM), middle fossa (MF) or combined approach repair of spontaneous MF CSF leak between 2016 and 2020.
INTERVENTIONS: Exposure of bony defect via TM approach, MF craniotomy, or combined TM/MF, and repair of the associated dura defect with FGCC complex patch, or other materials (acellular collagen matrix, bovine collagen, autologous fascia, fibrin tissue sealant).
MAIN OUTCOME MEASURES: Successful repair without recurrent CSF leak or encephalocele throughout follow-up. Cost of materials used in duraplasty.
RESULTS: Sixty-four percent of patients were female. Mean (standard deviation) age at repair was 61.4 (12.1) years. Mean (standard deviation) body mass index was 35.0 (8.3) kg/m2. Forty-nine (94%) patients had successful repair without known recurrence of CSF leak or encephalocele over a median follow-up interval of 11.7 months. Average duraplasty material cost was significantly lower with FGCC in comparison with other nonautologous materials (FGCC+: $1259.94, FGCC-: $1652.58; p = 0.004). No significant differences in recurrence risk (FGCC+: 6.9%, FGCC-: 6.9%; p > 0.999) or operative time (FGCC+: 153.7 min, FGCC-: 155.4 min; p = 0.88) were detected based on material used for duraplasty.
CONCLUSIONS: All materials studied demonstrate effective and sustained means of repair for MF CSF leak and encephalocele, including in the presence of multiple defects. Use of FGCC for duraplasty produces noninferior surgical results to other nonautologous materials in repair of spontaneous CSF leaks of the temporal bone and may be more cost-effective.
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