Efficacy and safety of a novel moldable, resorbable, and degradable sealant of bone surfaces for hemostasis after bone graft harvesting from the iliac crest

Spine

Volumn 30, Issue 17, 2005, Pages 1911-1917

  Pingsmann, Andreas ^a,g   Blatt, Ruth ^b   Breusch, Steffen ^c   Jürgens, Christian ^d   Thietje, Roland ^d   Krödel, Andreas ^e   Zinser, Wolfgang ^e   Michiels, Ivo ^a   Niethard, Fritz U ^f   Niedhart, Christopher ^f   Renzing Köhler, Katrin ^a   Pfefferle, Hans Joachim ^b  

^a UNIVERSITY OF ESSEN MEDICAL SCHOOL   (Germany)

^b MERCK KGAA   (Germany)

^c UNIVERSITY OF HEIDELBERG   (Germany)

^d Berufsgenossenschaftliche Unfallkrankenhaus Hamburg   (Germany)

^e ALFRIED KRUPP KRANKENHAUS   (Germany)

^f RWTH AACHEN UNIVERSITY   (Germany)

^g Biberburg Orthopaedic Associates   (Germany)

Author keywords

Biomaterial; Bone graft; Clinical safety; Hemostasis; Topical hemostat

Indexed keywords

BIOMATERIAL; C REACTIVE PROTEIN; COLLAGEN; HEMOSTATIC AGENT; POLYMER; SEALANT;

ADULT; AGED; ANEMIA; ARTICLE; BIODEGRADABILITY; BLEEDING; BONE GRAFT; BONE INJURY; BONE TUMOR; CANCELLOUS BONE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORTICAL BONE; DONOR; DRUG EFFICACY; DRUG SAFETY; FEMALE; FOOT MALFORMATION; FRACTURE NONUNION; HEMATOMA; HEMOSTASIS; HUMAN; ILIAC CREST; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; ORTHOPEDIC SURGERY; OSTEITIS; OSTEOLYSIS; POSTOPERATIVE INFECTION; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; SEROMA; SPINE DISEASE; SPINE SURGERY; WOUND HEALING IMPAIRMENT;

ADULT; BIODEGRADATION, ENVIRONMENTAL; COLLAGEN; FEMALE; HEMATOMA; HEMOSTATICS; HUMANS; ILIUM; MALE; MIDDLE AGED; POLYMERS; TISSUE AND ORGAN HARVESTING; TRANSPLANTS; TREATMENT OUTCOME; WOUND HEALING;

EID: 24744462493     PISSN: 03622436     EISSN: 15281159     Source Type: Journal    
DOI: 10.1097/01.brs.0000176324.00314.ef     Document Type: Article

References (43)

1. DePalma AF, Rothman RH, Lewinnek GE, et al. Anterior interbody fusion for severe cervical disc degeneration. Surg Gynecol Obstet 1972;134:755-8.
2. Younger EM, Chapman MW. Morbidity at bone graft donor sites. J Orthop Trauma 1989;3:192-5.
3. Banwart JC, Asher MA, Hassanein RS. Iliac crest bone graft harvest donor site morbidity: a statistical evaluation. Spine 1995;20:1055-60.
4. Arrington ED, Smith WJ, Chambers HG, et al. Complications of iliac crest bone graft harvesting. Clin Orthop 1996;329:300-9.
5. Russell JL, Block JE. Surgical harvesting of bone graft from the ilium: point of view. Med Hypotheses 2000;55:474-9.
6. Robertson PA, Wray AC. Natural history of posterior iliac crest bone graft donation for spinal surgery: a prospective analysis of morbidity. Spine 2001; 26:1473-6.
7. Turpie AGG, Gallus AS, Hoek JA. A synthetic pentasaccharide for the prevention of deep-vein thrombosis after total hip replacement. N Engl J Med 2001;344:619-25.
8. Bauer KA, Eriksson BI, Lassen MR, et al. Fondaparinux compared with enoxaparin for the prevention of venous thromboembolism after elective major knee surgery. N Engl J Med 2001;345:1305-10.
9. Harjula A, Järvinen A. Postoperative median sternotomy dehiscence. Scand J Thorac Cardiovasc Surg 1983;17:277-81.
10. Sarr MG, Gott VL, Townsend TR. Mediastinal infection after cardiac surgery. Ann Thorac Surg 1984;38:415-23.
11. Geary JR, Frantz VK. New absorbable hemostatic bone wax. Experimental and clinical studies. Ann Surg 1950;132:1128-37.
12. Harris WH, Crothers OD, Moyen BJL, et al. Topical hemostatic agents for bone bleeding in humans. J Bone Joint Surg Am 1978;60:454-6.
13. Finn MD, Schow SR, Schneiderman ED. Osseous regeneration in the presence of four common hemostatic agents. J Oral Maxillofac Surg 1992;50: 608-12.
14. Sugamori T, Iwase H, Maeda M, et al. Local hemostatic effect of microcrystalline partially deacetylated chitin hydrochloride. Biomed Mater Res 2000; 49:225-32.
15. Anfinsen OG, Sudmann B, Rait M. Complications secondary to the use of standard bone wax in seven patients. J Foot Ankle Surg 1993;32:505-7.
16. Allison RT. Foreign body reactions and an associated histological artefact due to bone wax. Br J Biomed Sci 1994;51:14-7.
17. Katz SE, Rootman J. Adverse effects of bone wax in surgery of the orbit. Ophthalmic Plast Reconstr Surg 1996;12:121-6.
18. Robicsek F, Masters TN, Littman L, et al. The embolization of bone wax from sternotomy incisions. Ann Thorac Surg 1981;31:357-9.
19. Orgill DP, Ehret FW, Regan JF, et al. Polyethylene glycol/microfibrillar collagen composite as a new resorbable hemostatic bone wax. J Biomed Mater Res 1998;39:358-63.
20. Sudmann B, Anfinsen OG, Bang G, et al. Assessment in rats of a new bioerodible bone-wax-like polymer. Acta Orthop Scand 1993;64:336-9.
21. Rousou J, Levitsky S, Gonzalez-Lavin L, et al. Randomized clinical trial of fibrin sealant in patients undergoing resternotomy or reoperation after cardiac operations. J Thorac Cardiovasc Surg 1989;97:194-203.
22. Berruyer M, Amiral J, Pfrench P, et al. Immunization by bovine thrombin used with fibrin glue during cardiovascular operations. J Thorac Cardiovasc Surg 1993;105:892-7.
23. Jackson MR, MacPhee MJ, Drohan WN, et al. Fibrin sealant: current and potential clinical applications. Blood Coagul Fibrinolysis 1996;7:37-46.
24. Schoenecker GJ, Johnson RK, Lesher AP, et al. Exposure of mice to topical bovine thrombin induces systemic autoimmunity. Am J Pathol 2001;159: 1957-69.
25. Ono K, Ishihara M, Ozeki Y, et al. Experimental evaluation of photocrosslinkable chitosan as a biologic adhesive with surgical applications. Surgery 2001;130:844-50.
26. Schmitt JM, Buck D, Bennett S, et al. Assessment of an experimental bone wax polymer plus TGF-β1 implanted into calvarial defects. J Biomed Mater Res 1998;41:584-92.
27. Engelhardt GH, Gerhardt H-J, Nagelschmidt M. Wirkungsamkeit und Biokompatibilität zweier Hämostyptika auf Kollagen-Basis im Tierexperiment. Arzneimittelforschung 1989;39:259-62.
28. R). Zentralbl Neurochir 1992;53:33-6.
29. Bauer P, Kohne K. Evaluation of experiments with adaptive interim analyses. Biometrics 1994;50:1029-41.
30. Abbott WM, Austen WG. The effectiveness and mechanism of collagen-induced topical hemostasis. Surgery 1975;78:723-9.
31. Cobden RH, Thrasher EL, Harris WH. Topical hemostatic agents to reduce bleeding from cancellous bone. A comparison of microcrystalline collagen, thrombin, and thrombin-soaked gelatin foam. J Bone Joint Surg Am 1976; 58:70-3.
32. Silverstein ME, Keown K, Owen JA, et al. Collagen fibers as a fleece hemostatic agent. J Trauma 1980;20:688-94.
33. Chvapil M, Owen JA, DeYoung DW. A standardized animal model for evaluation of haemostatic effectiveness of various materials. J Trauma 1983; 23:1042-47.
34. Blanche C, Chaux A. The use of absorbable microfibrillation collagen to control sternal bone marrow bleeding. Int Surg 1988;7:342-3.
35. Craig CC, Asher MA. Hemostasis in human iliac crest donor sites with microfibrillar collagen. Spine 1977;2:313-7.
36. Silverstein ME, Chvapil M. Experimental and clinical experiences with collagen fleece as a hemostatic agent. J Trauma 1981;21:388-93.
37. Kjaegard HK, Fairbrother JE. Controlled clinical studies of fibrin sealant in cardiothoracic surgery-a review. Eur J Cardiothorac Surg 1996;10:727-33.
38. Sherman R, Chapman WC, Hannon G, et al. Control of bone bleeding at the sternum and iliac crest donor sites using a collagen-based composite combined with autologous plasma: results of a randomized controlled trial. Orthopedics 2001;24:137-41.
39. Zwischenberger JB, Brunston RL, Swann JR, et al. Comparison of two topical collagen-based hemostatic sponges during cardiothoracic procedures. J Invest Surg 1999;12:101-6.
40. Oz MC, Cosgrove DM III, Badduke BR, et al. Controlled clinical trial of a novel hemostatic agent in cardiac surgery. Ann Thorac Surg 2000;69: 1376-82.
41. Wippermann BW, Schratt H-E, Steeg S, et al. Komplikationen der Spongiosaentnahme am Beckenkamm. Eine retrospektive Analyse von 1191 Fällen. Chirurg 1997;68:1286-91.
42. Kurz LT, Garfin SR, Booth RE Jr. Harvesting autogenous iliac bone grafts. A review of complications and techniques. Spine 1989;14:1324-31.
43. Merck Biomaterial GmbH. EMD85980. Physical, chemical, pharmaceutical, toxicological, and biocompatibility features. Darmstadt, Germany: Merck; 1999.