Collagen-only biomatrix as a novel dural substitute. Examination of the efficacy, safety and outcome: clinical experience on a series of 208 patients.
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.
Esposito
Felice
F
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
Cappabianca
Paolo
P
Fusco
Mario
M
Cavallo
Luigi M
LM
Bani
Giorgio G
GG
Biroli
Francesco
F
Sparano
Amelia
A
de Divitiis
Oreste
O
Signorelli
Antonio
A
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
C107909:Biomatrix preparation; D015718:Fibrin Tissue Adhesive; D007797:Laminin; D003094:Collagen