This paper reports the findings of a multicentre prospective randomised trial conducted to demonstrate the efficacy of the Adherus Dural Sealant for FDA approval. The Adherus Dural Sealant was compared with the control, DuraSeal Dural Sealant. It was applied to the dural defect and tested with a Valsava manoeuvre 30 seconds after application to check for a watertight seal. The sealant was reapplied if a leak was noticed and if there was a persistent leak, then it was closed conventionally. The authors concluded that the novel new sealant was as efficacious and safe as other existing hydrogel sealants. However, it had a distinct advantage over other sealants in the postoperative period as it had greater structural integrity and strength, expanded to a lesser extent and degraded more slowly. Studies like this one add to the existing literature on the various effective dural sealants available for the repair of CSF leaks.
A new hydrogel dural sealant for CSF repair
Reviewed by Gauri Mankekar
A pivotal randomized clinical trial evaluating the safety and effectiveness of a novel hydrogel dural sealant as an adjunct to dural repair.
CONTRIBUTOR
Gauri Mankekar
Department of Otolaryngology-Head Neck Surgery, Louisiana State University Shreveport, Louisiana, USA.
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