Results of the Prospective, Randomized, Multicenter Clinical Trial Evaluating a Biosynthesized Cellulose Graft for Repair of Dural Defects
Ahead of Print: Results of the Prospective, Randomized, Multicenter Clinical Trial Evaluating a Biosynthesized Cellulose Graft for Repair of Dural Defects
BACKGROUND: Following intradural cranial surgery, a dural substitute is often required for dural closure. Although preferred, limitations of autograft include local availability and additional surgical site morbidity. Thus, allografts, xenografts, and synthetics are frequently used.
OBJECTIVE: To report 6-month results of a randomized, controlled trial (RCT) of a biosynthesized cellulose (BSC) composed duraplasty device compared to commercially available dural replacements.
METHODS: A total of 99 patients (62 BSC; 37 control) were treated on protocol, utilizing a 2:1 (BSC:control) blocked randomization schedule. Physical examinations were performed pre- and post-operatively within 10 days, and 1, 3, and 6 months. An MRI was performed pre-operatively and at 6 months. The primary study endpoint was absence of pseudomeningocele and extracerebral fluid collection confirmed radiographically and absence of cerebrospinal fluid (CSF) fistula at 6 months.
RESULTS: At 6 months, the primary hypothesis, non-inferiority of the BSC implant to the control group, was confirmed (P = 0.0206). Overall success was achieved by 96.6% of BSC and 97.1% of control patients. No significant difference was revealed between treatment groups for surgical site infection (P = 1.0000) or wound healing assessment (P >= 0.3685) outcomes, or radiologic endpoints (P >= 0.4061). Device strength and seal quality favored BSC.
CONCLUSION: This RCT establishes BSC as non-inferior to commercially available dural replacement devices. BSC offers a hypothetical advantage concerning prion and other infectious agent exposure; superior handling qualities are evident. Longer-term data are necessary to identify limitations of BSC and its potential equivalence to the gold standard of pericranium.