Hsuan-Yi Wu, Po-Huang Chen, Chen-Shu Wu, Chun-Fu Lin, Sanford P C Hsu
In this small exploratory cohort, Foamagen demonstrated outcomes comparable with those of the standard sealant DuraSeal. Foamagen may therefore serve as a safe and effective alternative for preventing CSF leakage following CP angle tumor resection. However, the study was substantially underpowered to establish noninferiority, and larger prospective studies are warranted to confirm this observation.
BACKGROUND AND OBJECTIVES: Cerebrospinal fluid (CSF) leakage remains a common and clinically significant complication following skull base surgery, particularly with the translabyrinthine approach for cerebellopontine (CP) angle tumor resection. We aimed to evaluate the safety and efficacy of Foamagen in CP angle tumor resection performed through the translabyrinthine approach.
METHODS: Patients undergoing CP angle tumor resection using the translabyrinthine approach were categorized into 2 groups based on the dural closure material: the intervention group received Foamagen, whereas the control group received the standard sealant DuraSeal (Integra LifeSciences). Outcomes included CSF leakage (wound leak or rhinorrhea), surgical site infection, need for lumbar drainage, and reoperation at discharge and at 3-month follow-up.
RESULTS: Among 40 patients, 18 were assigned to the Foamagen group and 22 to the DuraSeal group. Baseline characteristics were comparable between the groups. At discharge, the incidence of CSF leakage was low and similar in both groups [5.6% (95% CI: 0.1%-27.3%) vs 4.5% (95% CI: 0.1%-22.8%); risk difference +1.0% (95% CI: -12.7% to +14.7%), P = 1.000]. No significant differences were observed in postoperative infection (5.6% vs 4.5%, P = 1.000), lumbar drain placement (11.1% vs 4.5%, P = .579), or reoperation rates (0% vs 4.5%, P = .369). At the 3-month follow-up, no CSF leakage or abnormal dural thickening was identified in either group.
CONCLUSION: In this small exploratory cohort, Foamagen demonstrated outcomes comparable with those of the standard sealant DuraSeal. Foamagen may therefore serve as a safe and effective alternative for preventing CSF leakage following CP angle tumor resection. However, the study was substantially underpowered to establish noninferiority, and larger prospective studies are warranted to confirm this observation.