title: Collagen-only biomatrix as a novel dural substitute. Examination of the efficacy, safety and outcome: clinical experience on a series of 208 patients.
abstract: OBJECTIVE
  Dural replacement materials and other measures can provide an effective barrier between the subarachnoid compartment and the extradural space when a watertight closure of the patient's own dura is not possible.
  
  
  METHODS
  We evaluated the efficacy and safety of a novel collagen-derived dural substitute on a series of 208 patients undergoing a variety of neurosurgical procedures.
  
  
  RESULTS
  No patients experienced any local or systemic complications nor toxicity related to the dural patch. No patients experienced post-operative CSF fistula except for one. Post-operative MRIs showed signs of moderate inflammatory response in only one patient, who did not present any post-operative clinical symptom nor neurological deficits. Three patients underwent reoperation for bone flap repositioning after decompressive craniectomy: in these cases, the dural substitute appeared to have promoted a satisfactory dural regeneration, as confirmed by the histological studies. Furthermore, in such cases no or minimal adherences with the other tissues and the brain cortex was observed.
  
  
  CONCLUSIONS
  The new collagen-only biomatrix is a safe and effective dural substitute for routine neurosurgical procedures. The absence of local and systemic toxicity or complications, and the scarce promotion of adherences and inflammation, make this material appealing for its use as dural substitute even in cases when a needed re-operation is anticipated.
authors.affiliation: Department of Neurological Sciences, Division of Neurosurgery, Università degli Studi di Napoli Federico II, Via Sergio Pansini, 5 - 80131 Naples, Italy. felice.espoisito@unina.it
authors.forename: Felice
authors.initials: F
authors.lastname: Esposito
authors.forename: Paolo
authors.initials: P
authors.lastname: Cappabianca
authors.forename: Mario
authors.initials: M
authors.lastname: Fusco
authors.forename: Luigi M
authors.initials: LM
authors.lastname: Cavallo
authors.forename: Giorgio G
authors.initials: GG
authors.lastname: Bani
authors.forename: Francesco
authors.initials: F
authors.lastname: Biroli
authors.forename: Amelia
authors.initials: A
authors.lastname: Sparano
authors.forename: Oreste
authors.initials: O
authors.lastname: de Divitiis
authors.forename: Antonio
authors.initials: A
authors.lastname: Signorelli
mesh_terms: D020341:Absorbable Implants; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001705:Bioprosthesis; D001706:Biopsy; D002648:Child; D002675:Child, Preschool; D003094:Collagen; D003399:Craniotomy / Q000379:methods*; D004388:Dura Mater / Q000473:pathology / Q000601:surgery*; D005260:Female; D015718:Fibrin Tissue Adhesive / Q000627:therapeutic use; D005500:Follow-Up Studies; D005549:Foreign-Body Reaction / Q000473:pathology; D048091:Guided Tissue Regeneration; D006488:Hemostasis, Surgical; D006801:Humans; D007797:Laminin; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D019635:Neurosurgical Procedures; D011183:Postoperative Complications / Q000175:diagnosis / Q000473:pathology / Q000601:surgery; D012086:Reoperation; D016896:Treatment Outcome
chemical_list: C107909:Biomatrix preparation; D015718:Fibrin Tissue Adhesive; D007797:Laminin; D003094:Collagen