New Dried Human Amniotic Membrane Is Useful as a Substitute for Dural Repair after Skull Base Surgery

Abstract

Objectives?Cerebrospinal fluid (CSF) leakage is an undesirable complication of skull base surgery. We used dried human amniotic membrane (AM) as a patch graft for dural repair to determine its efficacy in preventing CSF leakage. Design?Frontoparietal craniotomy and removal of dura were performed in 20 Wistar rats. A dried AM was placed to cover the dural defect without suturing in 16 animals. In four animals, an expanded polytetrafluoroethylene was implanted. At 2 weeks and 1, 3, and 6 months, histological examination was performed. Dried AM was also used as a substitute in 10 patients who underwent skull base surgery, after approval by the Ethics Committee of the University of Toyama. Results?At 2 weeks after implantation, thick connective tissue completely enclosed the dried AM. At 1?month after implantation, the connective tissue became thin and the implanted AM shortened. At 3 and 6 months after implantation, histological examination revealed disappearance of the dried AM and formation of membranous tissue. In the clinical study, neither CSF leakage nor clinical adverse reactions directly related to the dried AM were observed. Conclusion?Dried human AM appears to be an ideal substitute for dura, since it is replaced by natural tissue.

Effect of hyperdry amniotic membrane patches attached over the bony surface of mastoid cavities in canal wall down tympanoplasty

“…The AM was then air dried and sterilized by gamma irradiation at 25 kGy, which has been recommended for terminal sterilization of medical products 19. These procedures can completely prevent already‐known transmissible infections, and no adverse effects have been reported in patients receiving hyperdry AM grafts 10, 20. To manage unexpected risks, however, it is essential to accurately record in the recipient's case notes all unique donation numbers of all grafts used, to store samples corresponding to each donation number, and to undertake long‐term monitoring of the recipients after the operation.…”

Hyperdry human amniotic membrane is useful material for tissue engineering: Physical, morphological properties, and safety as the new biological material

“…The hyperdry device and sterilization by γ‐irradiation at 25 kGy, which has been recommended for terminal sterilization of medical products, can completely prevent known transmissible infections, and no adverse effects have been reported in patients who received HD‐AM grafts . Bacteriologic test also indicated that 25 kGy γ‐irradiation achieved to complete sterilization(data not shown).…”

“…HD‐AM was also shown to reduce wound dehydration. The details of these benefits are described in clinical observations and case reports …”

“…The details of these benefits are described in clinical observations and case reports. [29][30][31][32][33][34][35][36][37] The purposes of the present study were to (1) compare the physical and histological properties of HD-AM with those of freeze-dried human amniotic membrane (FD-AM) processed with typical freeze-dry methods, (2) evaluate the safety of HD-AM, and (3) demonstrate the feasibility of HD-AM transplantation in a case of recurrent pterygium.…”

Human Perinatal‐Derived Biomaterials

“…[61] Cells isolated from AM show potential to express neurosupportive factors;[62] amnion derived cells can be differentiated towards a Schwann cell-like lineage and their neurosupportive properties enhanced by the addition of neurotrophic factors. [63]…”