DuraSeal Exact Is a Safe Adjunctive Treatment for Durotomy in Spine: Postapproval Study.

ABSTRACT:

Study design

A nonrandomized, two-armed prospective study.

Objective

Water-tight dural closure is paramount to the prevention of cerebrospinal fluid (CSF) leakage and associated complications. Synthetic polyethylene glycol (PEG) hydrogel has been used as an adjunct to sutured dural repair; however, its expansion postoperatively is a concern for neurological complications. A low-swell formulation of PEG sealant was introduced as DuraSeal Exact Spine Sealant System (DESS). A Post-Approval Study was performed primarily to evaluate the safety and efficacy of DESS for spinal dural repair compared to current alternatives, in a large patient population, reflecting a real-world practice.

Methods

A total of 36 sites in the United States enrolled 429 patients treated with DESS

SUBMITTER: Kim KD 

PROVIDER: S-EPMC6542171 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature