Use of Acellular Fish Skin for Dura Repair in an Ovine Model: A Pilot Study
Author(s)
Hilmar Kjartansson1,2,
Ingvar Hakon Olafsson2,
Sigurbergur Karason2,
Hjalti Thorisson2,3,
Baldur Tumi Baldursson1,2,
Eggert Gunnarsson4,
Einar Jorundsson4,
Gudmundur Fertram Sigurjonsson1
Affiliation(s)
1 Kerecis Limited, Reykjavik, Iceland. 2 The National University Hospital of Iceland, Reykjavik, Iceland. 3 Domus Radiology Center, Reykjavik, Iceland. 4 The Institute for Experimental Pathology, University of Iceland, Reykjavik, Iceland.
1 Kerecis Limited, Reykjavik, Iceland. 2 The National University Hospital of Iceland, Reykjavik, Iceland. 3 Domus Radiology Center, Reykjavik, Iceland. 4 The Institute for Experimental Pathology, University of Iceland, Reykjavik, Iceland.
ABSTRACT
Recently the use of biologic materials as dura mater repair patches has been increasing. The purpose of this study is to assess the basis for efficacy and safety of using a novel fish derived acellular dermis (Kerecis Omega3 DuraTM). In an ovine model a craniotomy under general anaesthesia was performed. A defect was produced in the dural covering of approximately 1 × 2 cm and closed with an onlay technique, with Kerecis Omega3 Dura. The bone defect was covered with the bony flap and the overlying tissues closed in layers. At 2, 5, 8 and 11 weeks the sheep underwent MRI scanning followed by euthanasia, necropsy and histological assessment. MRI images taken at 2, 5, 8 and 11 weeks showed initially moderate inflammatory response, which diminished over time, and at 11 weeks no evidence of inflammation existed. There was evidence of cerebrospinal fluid leakage at no time point. Necropsy revealed some adhesions at 5 and 8 weeks, in particular at 5 weeks, but at 11 weeks there were no adhesions found. From 2 - 11 weeks, there was evidence of initially an inflammatory reaction followed by neodura formation at the defect site through cellular ingrowth and remodeling of the acellular fish skin. Histology showed a histiocytic foreign body reaction initially that subsided over time. As early as 8 weeks there was evidence of neodura formation and by 11 weeks there was a minimal inflammatory response with an intact neodura formed. In this pilot study the Kerecis Omega3 Dura patches performed in a safe and efficacious manner. This new material needs to be fully assessed and compared with other products that are currently on the market in a larger scale animal study.
Recently the use of biologic materials as dura mater repair patches has been increasing. The purpose of this study is to assess the basis for efficacy and safety of using a novel fish derived acellular dermis (Kerecis Omega3 DuraTM). In an ovine model a craniotomy under general anaesthesia was performed. A defect was produced in the dural covering of approximately 1 × 2 cm and closed with an onlay technique, with Kerecis Omega3 Dura. The bone defect was covered with the bony flap and the overlying tissues closed in layers. At 2, 5, 8 and 11 weeks the sheep underwent MRI scanning followed by euthanasia, necropsy and histological assessment. MRI images taken at 2, 5, 8 and 11 weeks showed initially moderate inflammatory response, which diminished over time, and at 11 weeks no evidence of inflammation existed. There was evidence of cerebrospinal fluid leakage at no time point. Necropsy revealed some adhesions at 5 and 8 weeks, in particular at 5 weeks, but at 11 weeks there were no adhesions found. From 2 - 11 weeks, there was evidence of initially an inflammatory reaction followed by neodura formation at the defect site through cellular ingrowth and remodeling of the acellular fish skin. Histology showed a histiocytic foreign body reaction initially that subsided over time. As early as 8 weeks there was evidence of neodura formation and by 11 weeks there was a minimal inflammatory response with an intact neodura formed. In this pilot study the Kerecis Omega3 Dura patches performed in a safe and efficacious manner. This new material needs to be fully assessed and compared with other products that are currently on the market in a larger scale animal study.
KEYWORDS
Duraplasty, Dura Repair, Piscine Acellular Dermal Graft, Neurosurgery, Dura Mater, Fish Skin Graft, Acellular Fish Skin, Craniotomy, Ovine Model, Dural Defect
Duraplasty, Dura Repair, Piscine Acellular Dermal Graft, Neurosurgery, Dura Mater, Fish Skin Graft, Acellular Fish Skin, Craniotomy, Ovine Model, Dural Defect
Cite this paper
Kjartansson, H. , Olafsson, I. , Karason, S. , Thorisson, H. , Baldursson, B. , Gunnarsson, E. , Jorundsson, E. and Sigurjonsson, G. (2015) Use of Acellular Fish Skin for Dura Repair in an Ovine Model: A Pilot Study. Open Journal of Modern Neurosurgery, 5, 124-136. doi: 10.4236/ojmn.2015.54021.
Kjartansson, H. , Olafsson, I. , Karason, S. , Thorisson, H. , Baldursson, B. , Gunnarsson, E. , Jorundsson, E. and Sigurjonsson, G. (2015) Use of Acellular Fish Skin for Dura Repair in an Ovine Model: A Pilot Study. Open Journal of Modern Neurosurgery, 5, 124-136. doi: 10.4236/ojmn.2015.54021.
References
[1] Barbolt, T.A., Odin, M., Léger, M., Kangas, L., Holste, J. and Liu, S.H. (2001) Biocompatibility Evaluation of Dura Mater Substitutes in an Animal Model. Neurological Research, 23, 813-820.
http://dx.doi.org/10.1179/016164101101199405 [2] Cappabianca, P., Esposito, F., Cavallo, L.M., Messina, A., Solari, D., di Somma, L.G.M. and de Divitiis, E. (2006) Use of Equine Collagen Foil as Dura Mater Substitute in Endoscopic Endonasal Transsphenoidal Surgery. Surgical Neurology, 65, 144-148; Discussion 149.
http://dx.doi.org/10.1016/j.surneu.2005.08.023 [3] Cavallo, L.M., Solari, D., Somma, T., Somma, A.Di, Chiaramonte, C. and Cappabianca, P. (2013) Use of Equine Pericardium Sheet (LYOMESH) as Dura Mater Substitute in Endoscopic Endonasal Transsphenoidal Surgery. Università degli Studi di Salerno, 7, 23-28. [4] Costa, B.S., Cavalcanti-Mendes, G.D.A., Abreu, M.S.De. and Sousa, A.A.De. (2011) Clinical Experience with a Novel Bovine Collagen Dura Mater Substitute. Arquivos de Neuro-Psiquiatria, 69, 217-220.
http://dx.doi.org/10.1590/S0004-282X2011000200015 [5] Esposito, F., Cappabianca, P., Fusco, M., Cavallo, L.M., Bani, G.G., Biroli, F. and Signorelli, A. (2008) Collagen-Only Biomatrix as a Novel Dural Substitute: Examination of the Efficacy, Safety and Outcome: Clinical Experience on a Series of 208 Patients. Clinical Neurology and Neurosurgery, 110, 343-351.
http://dx.doi.org/10.1016/j.clineuro.2007.12.016 [6] Williams, L.E., Vannemreddy, P.S., Watson, K.S. and Slavin, K.V. (2013) The Need in Dural Graft Suturing in Chiari I Malformation Decompression: A Prospective, Single-Blind, Randomized Trial Comparing Sutured and Sutureless Duraplasty Materials. Surgical Neurology International, 4, 26.
http://dx.doi.org/10.4103/2152-7806.107904 [7] Warren, W.L., Medary, M.B., Dureza, C.D., Bellotte, J.B., Flannagan, P.P., Oh, M.Y. and Fukushima, T. (2000) Dural Repair Using Acellular Human Dermis: Experience with 200 Cases: Technique Assessment. Neurosurgery, 46.
http://dx.doi.org/10.1097/00006123-200006000-00020 [8] Esmonde, T., Lueck, C.J., Symon, L., Duchen, L.W. and Will, R.G. (1993) Creutzfeldt-Jakob Disease and Lyophilised Dura Mater Grafts: Report of Two Cases. Journal of Neurology, Neurosurgery & Psychiatry, 56, 999-1000.
http://dx.doi.org/10.1136/jnnp.56.9.999 [9] Hoshi, K., Yoshino, H., Urata, J., Nakamura, Y., Yanagawa, H. and Sato, T. (2000) Creutzfeldt-Jakob Disease Associated with Cadaveric Dura Mater Grafts in Japan. Neurology, 55, 718-721.
http://dx.doi.org/10.1212/WNL.55.5.718 [10] Sekhar, L.N. and Mai, J.C. (2013) Dural Repair after Craniotomy and the Use of Dural Substitutes and Dural Sealants. World Neurosurgery, 79, 440-442.
http://dx.doi.org/10.1016/j.wneu.2011.12.062 [11] Asher, A.L., Carnahan, M.A., Boyd, R.B., Adams, E.L. and Butt, M.T. (2010) Adherus Dural and Spinal Sealant as Adjuncts to Sutured Dural Repair in a Canine Lumbar Durotomy Repair Model. HyperBranch Medical Technology, Inc., Durham. [12] Cetin, B., Sengül, G., Tüzün, Y., Gündogdu, C., Kadioglu, H.H. and Aydin, I.H. (2006) Suitability of Collagen Matrix as a Dural Graft in the Repair of Experimental Posterior Fossa Dura Mater Defects. Turkish Neurosurgery, 16, 9-13. [13] Knopp, U., Christmann, F., Reusche, E. and Sepehrnia, A. (2005) A New Collagen Biomatrix of Equine Origin versus a Cadaveric Dura Graft for the Repair of Dural Defects—A Comparative Animal Experimental Study. Acta Neurochirurgica, 147, 877-887.
http://dx.doi.org/10.1007/s00701-005-0552-0 [14] Neulen, A., Gutenberg, A., Takács, I., Wéber, G., Wegmann, J., Schulz-Schaeffer, W. and Giese, A. (2011) Evaluation of Efficacy and Biocompatibility of a Novel Semisynthetic Collagen Matrix as a Dural Onlay Graft in a Large Animal Model. Acta Neurochirurgica, 153, 2241-2250.
http://dx.doi.org/10.1007/s00701-011-1059-5
[1] Barbolt, T.A., Odin, M., Léger, M., Kangas, L., Holste, J. and Liu, S.H. (2001) Biocompatibility Evaluation of Dura Mater Substitutes in an Animal Model. Neurological Research, 23, 813-820.
http://dx.doi.org/10.1179/016164101101199405 [2] Cappabianca, P., Esposito, F., Cavallo, L.M., Messina, A., Solari, D., di Somma, L.G.M. and de Divitiis, E. (2006) Use of Equine Collagen Foil as Dura Mater Substitute in Endoscopic Endonasal Transsphenoidal Surgery. Surgical Neurology, 65, 144-148; Discussion 149.
http://dx.doi.org/10.1016/j.surneu.2005.08.023 [3] Cavallo, L.M., Solari, D., Somma, T., Somma, A.Di, Chiaramonte, C. and Cappabianca, P. (2013) Use of Equine Pericardium Sheet (LYOMESH) as Dura Mater Substitute in Endoscopic Endonasal Transsphenoidal Surgery. Università degli Studi di Salerno, 7, 23-28. [4] Costa, B.S., Cavalcanti-Mendes, G.D.A., Abreu, M.S.De. and Sousa, A.A.De. (2011) Clinical Experience with a Novel Bovine Collagen Dura Mater Substitute. Arquivos de Neuro-Psiquiatria, 69, 217-220.
http://dx.doi.org/10.1590/S0004-282X2011000200015 [5] Esposito, F., Cappabianca, P., Fusco, M., Cavallo, L.M., Bani, G.G., Biroli, F. and Signorelli, A. (2008) Collagen-Only Biomatrix as a Novel Dural Substitute: Examination of the Efficacy, Safety and Outcome: Clinical Experience on a Series of 208 Patients. Clinical Neurology and Neurosurgery, 110, 343-351.
http://dx.doi.org/10.1016/j.clineuro.2007.12.016 [6] Williams, L.E., Vannemreddy, P.S., Watson, K.S. and Slavin, K.V. (2013) The Need in Dural Graft Suturing in Chiari I Malformation Decompression: A Prospective, Single-Blind, Randomized Trial Comparing Sutured and Sutureless Duraplasty Materials. Surgical Neurology International, 4, 26.
http://dx.doi.org/10.4103/2152-7806.107904 [7] Warren, W.L., Medary, M.B., Dureza, C.D., Bellotte, J.B., Flannagan, P.P., Oh, M.Y. and Fukushima, T. (2000) Dural Repair Using Acellular Human Dermis: Experience with 200 Cases: Technique Assessment. Neurosurgery, 46.
http://dx.doi.org/10.1097/00006123-200006000-00020 [8] Esmonde, T., Lueck, C.J., Symon, L., Duchen, L.W. and Will, R.G. (1993) Creutzfeldt-Jakob Disease and Lyophilised Dura Mater Grafts: Report of Two Cases. Journal of Neurology, Neurosurgery & Psychiatry, 56, 999-1000.
http://dx.doi.org/10.1136/jnnp.56.9.999 [9] Hoshi, K., Yoshino, H., Urata, J., Nakamura, Y., Yanagawa, H. and Sato, T. (2000) Creutzfeldt-Jakob Disease Associated with Cadaveric Dura Mater Grafts in Japan. Neurology, 55, 718-721.
http://dx.doi.org/10.1212/WNL.55.5.718 [10] Sekhar, L.N. and Mai, J.C. (2013) Dural Repair after Craniotomy and the Use of Dural Substitutes and Dural Sealants. World Neurosurgery, 79, 440-442.
http://dx.doi.org/10.1016/j.wneu.2011.12.062 [11] Asher, A.L., Carnahan, M.A., Boyd, R.B., Adams, E.L. and Butt, M.T. (2010) Adherus Dural and Spinal Sealant as Adjuncts to Sutured Dural Repair in a Canine Lumbar Durotomy Repair Model. HyperBranch Medical Technology, Inc., Durham. [12] Cetin, B., Sengül, G., Tüzün, Y., Gündogdu, C., Kadioglu, H.H. and Aydin, I.H. (2006) Suitability of Collagen Matrix as a Dural Graft in the Repair of Experimental Posterior Fossa Dura Mater Defects. Turkish Neurosurgery, 16, 9-13. [13] Knopp, U., Christmann, F., Reusche, E. and Sepehrnia, A. (2005) A New Collagen Biomatrix of Equine Origin versus a Cadaveric Dura Graft for the Repair of Dural Defects—A Comparative Animal Experimental Study. Acta Neurochirurgica, 147, 877-887.
http://dx.doi.org/10.1007/s00701-005-0552-0 [14] Neulen, A., Gutenberg, A., Takács, I., Wéber, G., Wegmann, J., Schulz-Schaeffer, W. and Giese, A. (2011) Evaluation of Efficacy and Biocompatibility of a Novel Semisynthetic Collagen Matrix as a Dural Onlay Graft in a Large Animal Model. Acta Neurochirurgica, 153, 2241-2250.
http://dx.doi.org/10.1007/s00701-011-1059-5