title: Results of the prospective, randomized, multicenter clinical trial evaluating a biosynthesized cellulose graft for repair of dural defects.
abstract: BACKGROUND
  After 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 of a biosynthesized cellulose (BSC) composed duraplasty device compared with commercially available dural replacements.
  
  
  METHODS
  A total of 99 patients (62 BSC; 37 control) were treated on protocol, using a 2:1 (BSC:control) blocked randomization schedule. Physical examinations were performed pre- and postoperatively within 10 days and at 1, 3, and 6 months. Magnetic resonance imaging was performed preoperatively and at 6 months. The primary study endpoint was the absence of pseudomeningocele and extracerebral fluid collection confirmed radiographically and the absence of cerebrospinal fluid fistula at 6 months.
  
  
  RESULTS
  At 6 months, the primary hypothesis, noninferiority of the BSC implant compared with the control group, was confirmed (P = .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 ≥ .3685) outcomes, or radiologic endpoints (P ≥ .4061). Device strength and seal quality favored BSC.
  
  
  CONCLUSIONS
  This randomized, controlled trial establishes BSC as noninferior 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.
authors.affiliation: Department of Neurosurgery, West Virginia University School of Medicine, Morgantown, West Virginia 26506, USA. crosen@hsc.wvu.edu
authors.forename: Charles L
authors.initials: CL
authors.lastname: Rosen
authors.forename: Gary K
authors.initials: GK
authors.lastname: Steinberg
authors.forename: Franco
authors.initials: F
authors.lastname: DeMonte
authors.forename: Johnny B
authors.initials: JB
authors.lastname: Delashaw
authors.forename: Stephen B
authors.initials: SB
authors.lastname: Lewis
authors.forename: Mark E
authors.initials: ME
authors.lastname: Shaffrey
authors.forename: Khaled
authors.initials: K
authors.lastname: Aziz
authors.forename: Johanna
authors.initials: J
authors.lastname: Hantel
authors.forename: Frederick F
authors.initials: FF
authors.lastname: Marciano
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000818:Animals; D001672:Biocompatible Materials / Q000627:therapeutic use; D002417:Cattle; D002482:Cellulose / Q000737:chemistry / Q000627:therapeutic use*; D003399:Craniotomy / Q000379:methods*; D004388:Dura Mater / Q000601:surgery*; D005260:Female; D006801:Humans; D008297:Male; D008567:Membranes, Artificial; D008875:Middle Aged; D011446:Prospective Studies; D019651:Plastic Surgery Procedures / Q000379:methods*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001672:Biocompatible Materials; D008567:Membranes, Artificial; D002482:Cellulose