A randomized, controlled, prospective trial to evaluate the haemostatic effect of Lyostypt versus Surgicel in arterial bypass anastomosis: "COBBANA" trial

Trials

Volumn 10, Issue , 2009, Pages 91-

  Baumann, Petra ^a   Schumacher, Hardy ^b   Hüsing, Johannes ^c   Luntz, Steffen ^c   Knaebel, Hanns Peter ^a  

^a B Braun Melsungen AG   (Germany)

^b Klinikum Hanau GmbH   (Germany)

^c Coordinating Centre for Clinical Trials ^*  (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

COLLAGEN; OXIDIZED REGENERATED CELLULOSE; POLITEF;

ARTERY ANASTOMOSIS; ARTERY BYPASS; ARTERY PROSTHESIS; ARTICLE; BLEEDING; CLINICAL ARTICLE; CLINICAL EFFECTIVENESS; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; ELECTIVE SURGERY; FOLLOW UP; HEMOSTASIS; HUMAN; MORTALITY; PATIENT SAFETY; PERIPHERAL VASCULAR DISEASE; PEROPERATIVE CARE; PILOT STUDY; POSTOPERATIVE COMPLICATION; POSTOPERATIVE PERIOD; RANDOMIZED CONTROLLED TRIAL; SUTURE; TREATMENT RESPONSE; VASCULAR SURGERY;

BLOOD VESSEL PROSTHESIS IMPLANTATION; CELLULOSE, OXIDIZED; COLLAGEN; HEMOSTATICS; HUMANS; PERIPHERAL VASCULAR DISEASES; POLYTETRAFLUOROETHYLENE; PROSPECTIVE STUDIES; SUTURES;

EID: 70449482046     PISSN: 17456215     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-10-91     Document Type: Article

References (45)

1. Bellón JM, Buján J, Contreras LA, Hernando A, Jurado F. Similarity in behavior of polytetrafluoroethylene (ePTFE) prostheses implanted into different interfaces. J Biomed Mater Res 1996, 31(1):1-9. 10.1002/(SICI)1097-4636(199605)31:1<1::AID-JBM1>3.0.CO;2-S, 8731143.
2. Carney WI, Lilly MP. Intraoperative evaluation of PTFE, Dacron and autogenous vein as carotid patch materials. Ann Vasc Surg 1987, 1(5):583-586. 10.1016/S0890-5096(06)61445-3, 2974302.
3. Zdrahala RJ. Small caliber vascular grafts. Part I: state of the art. J Biomater Appl 1996, 10(4):309-329.
4. Lumsden AB, Heyman ER, . Closure Medical Surgical Sealant Study Group Prospective randomized study evaluating an absorbable cyanoacrylate for use in vascular reconstructions. J Vasc Surg 2006, 44(5):1002-1009. 10.1016/j.jvs.2006.06.039, 17020801.
5. Miller CM, Sangiolo P, Jacobson JH. Reduced anastomotic bleeding using new sutures with a needle-suture diameter ratio of one. Surgery 1987, 101(2):156-160.
6. Citrin P, Doscher W, Wise L, Margolis IB. Control of needle hole bleeding with ethyl-cyanoacrylate glue (Krazy Glue). J Vasc Surg 1985, 2(3):488-490. 10.1067/mva.1985.avs0020488, 3999241.
7. Hait MR, Robb CA, Baxter CR, Borgmann AR, Tippett LO. Comparative evaluation of Avitene microcrystalline collagen hemostat in experimental animal wounds. Am J Surg 1973, 125(3):284-287. 10.1016/0002-9610(73)90042-1, 4570330.
8. Hatsuoka M, Seiki M, Sasaki K, Kashii A. Hemostatic effects on microfibrillar collagen hemostat (MCH) in experimental coagulopathy model and its mechanism of hemostasis. Thromb Res 1986, 42(3):407-412. 10.1016/0049-3848(86)90269-0, 3520941.
9. Silverstein ME, Keown K, Owen JA, Chvapil M. Collagen fibers as a fleece hemostatic agent. J Trauma 1980, 20(8):688-694. 10.1097/00005373-198008000-00010, 7401211.
10. Czerny M, Verrel F, Weber H, Müller N, Kircheis L, Lang W, Steckmeier B, Trubel W. Collagen patch coated with fibrin glue components. Treatment of suture hole bleedings in vascular reconstruction. J Cardiovasc Surg 2000, 41(4):553-557.
11. Joseph T, Adeosun A, Paes T, Bahal V. Randomised controlled trial to evaluate the efficacy of TachoComb H patches in controlling PTFE suture-hole bleeding. Eur J Vasc Endovasc Surg 2004, 27(5):549-552. 10.1016/j.ejvs.2004.01.018, 15079782.
12. Jackson MR, Gillespie DL, Longenecker EG, Goff JM, Fiala LA, O'Donnell SD, Gomperts ED, Navalta LA, Hestlow T, Alving BM. Hemostatic efficacy of fibrin sealant (human) on expanded poly-tetrafluoroethylene carotid patch angioplasty: a randomized clinical trial. J Vasc Surg 1999, 30(3):461-466. 10.1016/S0741-5214(99)70073-X, 10477639.
13. Taylor LM, Mueller-Velten G, Koslow A, Hunter G, Naslund T, Kline R, . Beriplast B Investigators Prospective randomized multicenter trial of fibrin sealant versus thrombin-soaked gelatin sponge for suture- or needle-hole bleeding from polytetrafluoroethylene femoral artery grafts. J Vasc Surg 2003, 38(4):766-771. 10.1016/S0741-5214(03)00474-9, 14560228.
14. Glickman M, Gheissari A, Money S, Martin J, Ballard JL, . CoSeal Multicenter Vascular Surgery Study Group A polymeric sealant inhibits anastomotic suture hole bleeding more rapidly than gelfoam/thrombin: results of a randomized controlled trial. Arch Surg 2002, 137(3):326-331. 10.1001/archsurg.137.3.326, 11888460.
15. Schonauer C, Tessitore E, Barbagallo G, Albanese V, Moraci A. The use of local agents: bone wax, gelatin, collagen, oxidized cellulose. Eur Spine J 2004, 13(Suppl 1):89-96.
16. Wachol-Drewek Z, Pfeiffer M, Scholl E. Comparative investigation of drug delivery of collagen implants saturated in antibiotic solutions and a sponge containing gentamicin. Biomaterials 1996, 17:1733-1738. 10.1016/0142-9612(96)87654-X, 8866036.
17. Bauer P, Köhne K. Evaluation of Experiments with Adaptive Interim Analysis. Biometrics 1994, 50:1029-1041. 10.2307/2533441, 7786985.
18. Keiding N, Andersen PK, Klein JP. The Role of Frailty Models and Accelerated Failure Time Models in Describing Heterogeneity Due to Omitted Covariates. Statistics in Medicine 1997, 16(2):215-224. 10.1002/(SICI)1097-0258(19970130)16:2<215::AID-SIM481>3.0.CO;2-J, 9004393.
19. Bechstein WO, Strey C. Möglichkeiten der lokalen und systemischen Blutstillung bei chirurgischen Eingriffen. Chirurg 2007, 78:95-100. 10.1007/s00104-006-1289-x, 17237955.
20. Pingsmann A, Balt R, Breusch S, Jürgens C, Thietje R, Krödel A, Zinser W, Michiels I, Niethard F, Niedhart C, Renzing-Köhler K, Pfefferlet HJ. Efficacy and Safety of a novel moldable, resorbable and degradable sealant of bone surface for hemostasis after bone graft harvesting from the iliac crest. Spine 2005, 17:1911-1917.
21. Haris WH, Crothers OD, Moyen BJL. Topical hemostatic agents for bone bleeding in humans. J Bone Joint Surg Am 1978, 60:454-456.
22. Sherman R, Chapman WC, Hannon G. 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, 24:137-141.
23. Zwischenberger JB, Brunston RL, Swann JR. Comparison of two topical collagen-based hemostatic sponges during cardiothoracic procedures. J Invest Surg 1999, 12:101-106. 10.1080/089419399272656, 10327079.
24. Oz MC, Cosgrove DM, Badduke BR. Controlled clinical trial of a novel hemostatic agent in cardiac surgery. Ann Thorac Surg 2000, 69:1376-1382. 10.1016/S0003-4975(00)01194-2, 10881808.
25. Krüger J. Blutstillung bei neurochirurgischen Operationen. Eine Vergleichsstudie zwischen einem Kollagenvlies (Lyostypt®) und einem Gelatine Schwämmchen (Marbagelan®). Zentralbl Neurochir 1992, 53:33-36.
26. Rengachary SS, Manguoglou AB. Control of bone bleeding during Cloward procedure. J Neurosurg 1980, 52:138-139. 10.3171/jns.1980.52.1.0138, 7350275.
27. Zirna H, Keating SE, De Vincentis AF. Topical hemostatic agents to reduce bleeding from cancellous bone surfaces: a comparison of Gelfoam paste and bone wax. J Foot Surg 1987, 26(6):496-500.
28. Voormolen JH, Ringers J, Bots GT. Haemostatic agents: brain tissue reaction and effectiveness. A comparative animal study using collagen fleece and oxidized cellulose. Neurosurgery 1987, 20:702-709. 10.1097/00006123-198705000-00005, 3601016.
29. Rybock JD, Long DM. Use of microfibrillar collagen as a topical hemostatic agent in brain tissue. J Neurosurg 1977, 46:501-505. 10.3171/jns.1977.46.4.0501, 845633.
30. Wagner WR, Pachence JM, Ristich J, Johnson PC. Comparative in vitro analysis of topical hemostatic agents. J Surg Res 1996, 66:100-108. 10.1006/jsre.1996.0379, 9024819.
31. Finn MD, Schow SR, Schneideman ED. Osseous regeneration in the presence of four common hemostatic agents. J Oral Maxillofac Surg 1992, 50:608-612. 10.1016/0278-2391(92)90443-4, 1593323.
32. Raccuia JS, Simonian G, Dardik M, Hallaac D, Raccuia SV, Stahl R, Dardik H. Comparative efficacy of topical hemostatic agents in a rat kidney model. Am J Surg 1992, 163:234-238. 10.1016/0002-9610(92)90108-4, 1739179.
33. Ünlü Y, Vural T, Kocak H, Ceviz M, Becit N, Akbulut T. Comparison of the topical haemostatic agents for the prevention of suture hole bleeding. An experimental study. Eur J Vasc Endovasc Surg 2002, 23:441-444. 10.1053/ejvs.2002.1619, 12027473.
34. Dickneite G, Metzner H, Nicolay U. Prevention of suture hole bleeding using fibrin sealant: benefits of factor XIII. J Surg Res 2000, 93:201-205. 10.1006/jsre.2000.5985, 11027461.
35. Chapman W, Sherman R, Boyce S, Malawer M, Hill A, Buncke G, Block J, Fung J, Clavien P, Lee K, Lebovic G, Wren S, Diethrich E, Goldstein R. A novel collagen-based composite offers effective hemostasis for multiple surgical indications: Results of a randomized controlled trial. Surgery 2001, 129:445-450. 10.1067/msy.2001.112365, 11283536.
36. Chapman W, Clavien P, Fung J, Kanna A, Bonham A. Effective control of hepatic bleeding using a novel collagen-based composite combined with autologous plasma: Results of a randomized controlled trial. Arch Surg 2000, 13:1200-1204.
37. Engelhardt GH, Gerhardt HJ, Nagelschmidt M. Wiksamkeit und Biokompatibilität zweier Hämostyptika auf Kollagen-Basis im Tierexperiment. Arzneimittel Forsch/Drug Res 1989, 39:259-262.
38. Orgill DP, Ehret F, Regan JF. Polyethylene glycol/microfibrillar collagen composite as a new resorbable hemostatic bone wax. J Biomed Mater Res 1988, 39:358-363.
39. Abbott WM, Austen WG. Effectiveness and mechanism of collagen- induced topical hemostasis. Surgery 1975, 78:723-729.
40. Cobden RH, Thrasher EL, Harris WH. Topical hemostatic agents to reduce bleeding from canellous bone, A comparison of microcrystalline collagen, thrombin, and thrombin soaked gelatine foam. J Bone Joint Surg Am 1976, 58:70-73.
41. Chvapil M, Owen JA, De Young DW. A standardized animal model for evaluation of haemostatic effectiveness of varios materials. J Trauma 1983, 23:1042-1047. 10.1097/00005373-198312000-00004, 6655749.
42. Blanche C, Chaux A. The use of absorbable microfibrillation collagen to control sternal bone marrow bleeding. Int Surg 1988, 7:342-343.
43. Craig CC, Asher MA. Hemostasis in human iliac crest donor sites with microfibrillar collagen. Spine 1977, 2:313-317.
44. Silverstein ME, Chvapil M. Experimental and clinical experience with collagen fleece as a hemostatic agent. J Trauma 1981, 21:388-393. 10.1097/00005373-198105000-00011, 7230285.
45. Bland JM, Bland DG. Statistics Notes: One and two sided tests of significance. BMJ 1994, 309(6949):248+. 2540725, 8069143.