Application of a new hydrogel dural sealant that reduces epidural adhesion formation: Evaluation in a large animal laminectomy model

Journal of Neurosurgery: Spine

Volumn 12, Issue 4, 2010, Pages 381-390

  Preul, Mark C ^a   Campbell, Patrick K ^a   Garlick, David S ^b   Spetzler, Robert F ^a  

^a BARROW NEUROLOGICAL INSTITUTE   (United States)

^b Histo Scientific Research Laboratories Inc   (United States)

Author keywords

Cerebrospinal fluid leak; Dural repair; Dural sealant; Epidural adhesions; Hydrogel

Indexed keywords

MACROGOL; SEALANT;

ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; ARTICLE; CONTROLLED STUDY; DOG; EPIDURAL ADHESION; EPIDURAL SPACE; GAS ASSISTED SPRAYER; HISTOPATHOLOGY; HYDROGEL; INTRAOPERATIVE PERIOD; LAMINECTOMY; LIQUORRHEA; NONHUMAN; PARAMENINGEAL DISORDER; PROPHYLAXIS; SCORING SYSTEM; SURGICAL EQUIPMENT; SURGICAL TECHNIQUE; SUTURE; SYRINGE SPRAYER; TISSUE REPAIR; VALSALVA MANEUVER; WOUND COMPLICATION;

AEROSOLS; ANIMALS; CEREBROSPINAL FLUID; CICATRIX; DOGS; DURA MATER; EPIDURAL SPACE; FEMALE; HYDROGEL; LAMINECTOMY; POLYETHYLENE GLYCOLS; TIME FACTORS; TISSUE ADHESIONS; TISSUE ADHESIVES; WOUND HEALING;

EID: 77950582440     PISSN: 15475654     EISSN: 15475646     Source Type: Journal    
DOI: 10.3171/2009.10.SPINE09537     Document Type: Article

References (56)

1. Agrillo U, Simonetti G, Martino V: Postoperative CSF problems after spinal and lumbar surgery. General review. J Neurosurg Sci 35:93-95, 1991
2. Assietti R, Mora A, Brayda-Bruno M: Use of carboxymethylcellulose/ polyethylene oxide gel in microdiscectomy with interlaminectomy: a case series comparison with long-term follow-up. Spine 33:1762-1765, 2008
3. Atlas SJ, Deyo RA, Patrick DL, Convery K, Keller RB, Singer DE: The Quebec Task Force classification for Spinal Disorders and the severity, treatment, and outcomes of sciatica and lumbar spinal stenosis. Spine 21:2885-2892, 1996
4. Blackburn SL, Smyth MD: Hydrogel-induced cervicomedullary compression after posterior fossa decompression for Chiari malformation. Case report. J Neurosurg 106 (4 Suppl): 302-304, 2007
5. Boogaarts JD, Grotenhuis JA, Bartels RH, Beems T: Use of a novel absorbable hydrogel for augmentation of dural repair: results of a preliminary clinical study. Neurosurgery 57 (1 Suppl):146-151, 2005
6. Bosacco SJ, Gardner MJ, Guille JT: Evaluation and treatment of dural tears in lumbar spine surgery: a review. Clin Orthop Relat Res 389:238-247, 2001
7. Bryce GE, Nedzelski JM, Rowed DW, Rappaport JM: Cerebrospinal fluid leaks and meningitis in acoustic neuroma surgery. Otolaryngol Head Neck Surg 104:81-87, 1991
8. Cammisa FP Jr, Girardi FP, Sangani PK, Parvataneni HK, Cadag S, Sandhu HS: Incidental durotomy in spine surgery. Spine 25:2663-2667, 2000
9. Carlson GD, Oliff HS, Gorden C, Smith J, Anderson PA: Cerebral spinal fluid pressure: effects of body position and lumbar subarachnoid drainage in a canine model. Spine 28:119-122, 2003
10. Cosgrove GR, Delashaw JB, Grotenhuis JA, Tew JM, Van Loveren H, Spetzler RF, et al: Safety and efficacy of a novel polyethylene glycol hydrogel sealant for watertight dural repair. J Neurosurg 106:52-58, 2007
11. Danish SF, Samdani A, Hanna A, Storm P, Sutton L: Experience with acellular human dura and bovine collagen matrix for duraplasty after posterior fossa decompression for Chiari malformations. J Neurosurg 104 (1 Suppl):16-20, 2006
12. de Tribolet N, Porchet F, Lutz TW, Gratzl O, Brotchi J, van Alphen HA, et al: Clinical assessment of a novel antiadhesion barrier gel: prospective, randomized, multicenter, clinical trial of ADCON-L to inhibit postoperative peridural fibrosis and related symptoms after lumbar discectomy. Am J Orthop 27: 111-120, 1998
13. Einhaus SL, Robertson JT, Dohan FC Jr, Wujek JR, Ahmad S: Reduction of peridural fibrosis after lumbar laminotomy and discectomy in dogs by a resorbable gel (ADCON-L). Spine 22:1440-1447, 1997
14. Frilling A, Stavrou GA, Mischinger HJ, de Hemptinne B, Rokkjaer M, Klempnauer J, et al: Effectiveness of a new carrier- bound fibrin sealant versus argon beamer as haemostatic agent during liver resection: a randomised prospective trial. Langenbecks Arch Surg 390:114-120, 2005
15. Ganzer D, Giese K, Völker L, Pietzner U, Follak N, Merk H: Two-year results after lumbar microdiscectomy with and without prophylaxis of a peridural fibrosis using Adcon-L. Arch Orthop Trauma Surg 123:17-21, 2003
16. Haq I, Cruz-Almeida Y, Siqueira EB, Norenberg M, Green BA, Levi AD: Postoperative fibrosis after surgical treatment of the porcine spinal cord: a comparison of dural substitutes. Invited submission from the Joint Section Meeting on Disorders of the Spine and Peripheral Nerves, March 2004. J Neurosurg Spine 2:50-54, 2005
17. Hawk M, Kim KD: Review of spinal pseudomeningoceles and cerebrospinal fluid fistulas. Neurosurg Focus 9(1):e5, 2000
18. Hieb LD, Stevens DL: Spontaneous postoperative cerebrospinal fluid leaks following application of anti-adhesion barrier gel: case report and review of the literature. Spine 26:748- 751, 2001
19. Hu RW, Jaglal S, Axcell T, Anderson G: A population-based study of reoperations after back surgery. Spine 22:2265-2271, 1997
20. Iskander BJ, Fulmer BB, Hadley MN, Oakes WJ: Congenital tethered spinal cord syndrome in adults. Neurosurg Focus 10(1):e7, 2001
21. Ivanic GM, Pink PT, Schneider F, Stuecker M, Homann NC, Preidler KW: Prevention of epidural scarring after microdiscectomy: a randomized clinical trial comparing gel and expanded polytetrafluoroethylene membrane. Eur Spine J 15:1360-1366, 2006
22. Jacobs RR, McClain O, Neff J: Control of postlaminectomy scar formation: an experimental and clinical study. Spine 5: 223-229, 1980
23. Jo YW, Youn YS, Lee SH, Kim BM, Kang SH, Yoo M, et al: Long-acting interferon-alpha 2a modified with a trimer-structured polyethylene glycol: preparation, in vitro bioactivity, in vivo stability and pharmacokinetics. Int J Pharm 309:87-93, 2006
24. Kato T, Haro H, Komori H, Shinomiya K: Evaluation of hyaluronic acid sheet for the prevention of postlaminectomy adhesions. Spine J 5:479-488, 2005
25. Khan MH, Rihn J, Steele G, Davis R, Donaldson WF III, Kang JD, et al: Postoperative management protocol for incidental dural tears during degenerative lumbar spine surgery: a review of 3,183 consecutive degenerative lumbar cases. Spine 31:2609-2613, 2006
26. Kim KD, Wang JC, Robertson DP, Brodke DS, Olson EM, Duberg AC, et al: Reduction of radiculopathy and pain with Oxiplex/SP gel after laminectomy, laminotomy, and discectomy: a pilot clinical study. Spine 28:1080-1088, 2003
27. Kramer KM: RE: Unrecognized durotomy after lumbar discetomy: a report of four cases associated with the use of ADCON-L. Spine 2001; 26: 115-8.
28. Spine 26: 2405, 2001
29. Kuhn J, Hofmann B, Knitelius HO, Coenen HH, Bewermeyer H: Bilateral subdural haematomata and lumbar pseudomeningocele due to a chronic leakage of liquor cerebrospinalis after a lumbar discectomy with the application of ADCON-L gel. J Neurol Neurosurg Psychiatry 76:1031-1033, 2005
30. Kurt G, Cemil B, Celik B, Durdag E, Erdem O, Ceviker N: Comparison of Oxiplex and Gore-Tex effectivity in an experimental peridural fibrosis model. Neurocirugia (Astur) 20:360-366, 2009
31. Lanigan RS, Yamarik TA : Final report on the safety assessment of PEG-6, -8, and -20 sorbitan beeswax. Int J Toxicol 20 (Suppl 4):27-38, 2001
32. LaRocca H, Macnab I: The laminectomy membrane. Studies in its evolution, characteristics, effects and prophylaxis in dogs. J Bone Joint Surg Br 56B:545-550, 1974
33. Le AX, Rogers DE, Dawson EG, Kropf MA, De Grange DA, Delamarter RB: Unrecognized durotomy after lumbar discectomy: a report of four cases associated with the use of ADCON- L. Spine 26:115-118, 2001
34. Lee JY, Stenzel W, Ebel H, Wedekind C, Ernestus RI, Klug N: Mitomycin C in preventing spinal epidural fibrosis in a laminectomy model in rats. J Neurosurg 100 (1 Suppl Spine):52-55, 2004
35. Long DM, Filtzer DL, BenDebba M, Hendler NH: Clinical features of the failed-back syndrome. J Neurosurg 69:61-71, 1988
36. Malter AD, McNeney B, Loeser JD, Deyo RA: 5-year reoperation rates after different types of lumbar spine surgery. Spine 23:814-820, 1998
37. Matula C, Steiger CN, Hemostasis and Fleece-Bound Sealing in Neurosurgery. Stuttgart, Germany: Thieme, 2005
38. Mulder M, Crosier J, Dunn R: Cauda equina compression by hydrogel dural sealant after a laminotomy and discectomy: case report. Spine 34:E144-E148, 2009
39. Narotam PK, José S, Nathoo N, Taylon C, Vora Y: Collagen matrix (DuraGen) in dural repair: analysis of a new modified technique. Spine 29:2861-2869, 2004
40. Narotam PK, Van Dellen JR, Bhoola K, Raidoo D: Experimental evaluation of collagen sponge as a dural graft. Br J Neurosurg 7:635-641, 1993
41. Narotam PK, van Dellen JR, Bhoola KD: A clinicopathological study of collagen sponge as a dural graft in neurosurgery. J Neurosurg 82:406-412, 1995
42. Osada H, Tanaka H, Fujii TK, Tsunoda I, Yoshida T, Satoh K: Clinical evaluation of a haemostatic and anti-adhesion preparation used to prevent post-surgical adhesion. J Int Med Res 27:247-252, 1999
43. Porchet F, Lombardi D, de Preux J, Pople IK: Inhibition of epidural fibrosis with ADCON-L: effect on clinical outcome one year following re-operation for recurrent lumbar radiculopathy. Neurol Res 21 (Suppl 1):S51-S60, 1999
44. Preul MC, Bichard WD, Spetzler RF: Toward optimal tissue sealants for neurosurgery: use of a novel hydrogel sealant in a canine durotomy repair model. Neurosurgery 53:1189-1199, 2003
45. Preul MC, Campbell PK, Bichard WD, Spetzler RF: Application of a hydrogel sealant improves watertight closures of duraplasty onlay grafts in a canine craniotomy model. J Neurosurg 107:642-650, 2007
46. Richter HP, Kast E, Tomczak R, Besenfelder W, Gaus W: Results of applying ADCON-L gel after lumbar discectomy: the German ADCON-L study. J Neurosurg 95 (2 Suppl): 179-189, 2001
47. Robertson JT, Maier K, Anderson RW, Mulé JL, Palatinsky EA: Prevention of epidural fibrosis with ADCON-L in presence of a durotomy during lumbar disc surgery: experiences with a pre-clinical model. Neurol Res 21 (Suppl 1):S61-S66, 1999
48. Rodgers KE, Robertson JT, Espinoza T, Oppelt W, Cortese S, diZerega GS, et al: Reduction of epidural fibrosis in lumbar surgery with Oxiplex adhesion barriers of carboxymethylcellulose and polyethylene oxide. Spine J 3:277-284, 2003
49. Sciubba DM, Kretzer RM, Wang PP: Acute intracranial subdural hematoma following a lumbar CSF leak caused by spine surgery. Spine 30:E730-E732, 2005
50. Silvers HR, Lewis PJ, Asch HL, Clabeaux DE: Lumbar diskectomy for recurrent disk herniation. J Spinal Disord 7:408- 419, 1994
51. Smyth HF Jr, Carpenter CP, Weil CS: The toxicology of the polyethylene glycols. J Am Pharm Assoc Am Pharm Assoc 39:349-354, 1950
52. Songer MN, Ghosh L, Spencer DL: Effects of sodium hyaluronate on peridural fibrosis after lumbar laminotomy and discectomy. Spine 15:550-554, 1990
53. Tatsui CE, Martinez G, Li X, Pattany P, Levi AD: Evaluation of DuraGen in preventing peridural fibrosis in rabbits. Invited submission from the Joint Section Meeting on Disorders of the Spine and Peripheral Nerves, March 2005. J Neurosurg Spine 4:51-59, 2006
54. Yamaoka T, Tabata Y, Ikada Y: Fate of water-soluble polymers administered via different routes. J Pharm Sci 84:349-354, 1995
55. Zerris VA, James KS, Roberts JB, Bell E, Heilman CB: Repair of the dura mater with processed collagen devices. J Biomed Mater Res B Appl Biomater 83:580-588, 2007
56. Zou X, Li H, Egund N, Lind M, Bünger C: Inhibition of spinal fusion by use of a tissue ingrowth inhibitor. Eur Spine J 13:157-163, 2004