Trial to Evaluate the Hemostatic Effect of Lyostypt® Versus Surgicel® in Arterial Bypass Anastomosis
NCT ID: NCT00837954
Last Updated: 2015-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
32 participants
INTERVENTIONAL
2009-02-28
2010-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Influence Cirrhosis of the Liver on the Coronary Re-stenosis (LTX- Stent Study)
NCT02809248
Registry of Patients With Acute/Subacute Type B Aortic Dissection Treated by Means of the STABILISE Technique (STABILISE)
NCT03707743
High Coverage CARotid Stenting vs. Medical Management Alone to Prevent EmboliSm From symptomaTic Non-stenotic cARotid Disease (SyNC)
NCT07166731
Self-Centering Guide Catheter Feasibility Study
NCT02639494
Carotid Artery Revascularization Using the Boston Scientific EPI Filter Wire EZ™ and the EndoTex™ NexStent™
NCT00600327
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This study is designed to demonstrate the superiority of Lyostypt® to oxidized cellulose (Surgicel®) for hemostasis of suture hole bleeding in arterial bypass anastomoses after vascular reconstruction. Lyostypt® is an absorbable, wet stable collagen compress made of collagen fibrils of bovine origin. Collagen leads to thrombocyte adhesion and to activation of coagulation factor XII. Therefore collagen is very effective in hemostasis. Collagen is cell-friendly whereas other hemostats significantly disturb cell growth. Advantages of collagen fleece are fast induction of hemostasis, low tissue reaction and fast absorption (15). Furthermore, collagen was shown to be the best overall hemostatic agent in microvascular surgery. Authors concluded that collagen fleece establish faster hemostasis than oxidized cellulose and that it was resorbed faster than oxidized cellulose (15).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
distal Anastomosis Lyostypt®, proximal Anastomosis Surgicel®
Lyostypt® AND Surgicel®
The investigational products are the hemostats Lyostypt® and Surgicel® (=Tabotamp® ). Lyostypt® will be provided in the size 5cm x 8cm, Surgicel® will be provided in the size 5cm x 7,5cm. The devices will be cut into half.
Lyostypt® is an absorbable wet-stable collagen compress made of collagen fibrils of bovine origin. Collagen leads to thrombocyte adhesion and to activation of coagulation factor XII.
Surgicel® absorbable Haemostat is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. After Surgicel® has been saturated with blood, it swells into a brownish or black gelatinous mass which aids in the formation of a clot, thereby serving as a haemostatic adjunct in the control of local haemorrhage.
2
distal Anastomosis Surgicel®, proximal Anastomosis Lyostypt®
Lyostypt® AND Surgicel®
The investigational products are the hemostats Lyostypt® and Surgicel® (=Tabotamp® ). Lyostypt® will be provided in the size 5cm x 8cm, Surgicel® will be provided in the size 5cm x 7,5cm. The devices will be cut into half.
Lyostypt® is an absorbable wet-stable collagen compress made of collagen fibrils of bovine origin. Collagen leads to thrombocyte adhesion and to activation of coagulation factor XII.
Surgicel® absorbable Haemostat is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. After Surgicel® has been saturated with blood, it swells into a brownish or black gelatinous mass which aids in the formation of a clot, thereby serving as a haemostatic adjunct in the control of local haemorrhage.
3
distal and proximal Anastomosis Lyostypt®
Lyostypt®
The investigational product is the hemostat Lyostypt®. Lyostypt® will be provided in the size 5cm x 8cm. The devices will be cut into half.
Lyostypt® is an absorbable wet-stable collagen compress made of collagen fibrils of bovine origin. Collagen leads to thrombocyte adhesion and to activation of coagulation factor XII.
4
distal and proximal Anastomosis Surgicel®
Surgicel®
The investigational product is the hemostat Surgicel® (=Tabotamp® ). Surgicel® will be provided in the size 5cm x 7,5cm. The devices will be cut into half.
Surgicel® absorbable Haemostat is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. After Surgicel® has been saturated with blood, it swells into a brownish or black gelatinous mass which aids in the formation of a clot, thereby serving as a haemostatic adjunct in the control of local haemorrhage.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lyostypt® AND Surgicel®
The investigational products are the hemostats Lyostypt® and Surgicel® (=Tabotamp® ). Lyostypt® will be provided in the size 5cm x 8cm, Surgicel® will be provided in the size 5cm x 7,5cm. The devices will be cut into half.
Lyostypt® is an absorbable wet-stable collagen compress made of collagen fibrils of bovine origin. Collagen leads to thrombocyte adhesion and to activation of coagulation factor XII.
Surgicel® absorbable Haemostat is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. After Surgicel® has been saturated with blood, it swells into a brownish or black gelatinous mass which aids in the formation of a clot, thereby serving as a haemostatic adjunct in the control of local haemorrhage.
Lyostypt®
The investigational product is the hemostat Lyostypt®. Lyostypt® will be provided in the size 5cm x 8cm. The devices will be cut into half.
Lyostypt® is an absorbable wet-stable collagen compress made of collagen fibrils of bovine origin. Collagen leads to thrombocyte adhesion and to activation of coagulation factor XII.
Surgicel®
The investigational product is the hemostat Surgicel® (=Tabotamp® ). Surgicel® will be provided in the size 5cm x 7,5cm. The devices will be cut into half.
Surgicel® absorbable Haemostat is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. After Surgicel® has been saturated with blood, it swells into a brownish or black gelatinous mass which aids in the formation of a clot, thereby serving as a haemostatic adjunct in the control of local haemorrhage.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* suture hole bleeding of peripheral arterial bypass anastomosis using PTFE graft prosthesis
* Written informed consent
Exclusion Criteria
* Patients with coagulopathy or uremia
* Reoperation within one month at the same location
* Pregnant and Breastfeeding Women
* Known or suspected allergies or hypersensitivity to any of the used devices (e.g. to material of bovine origin)
* Severe comorbidity (ASA ≥ 4)
* Life expectancy less than 12 months
* Current immunosuppressive therapy (more than 40 mg of corticoid per day or ezathioprin)
* Chemotherapy within last 4 weeks
* Radiotherapy on the treated region within the last 2 months
* Severe psychiatric or neurologic diseases
* Lack of compliance
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Aesculap AG
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hardy Schumacher, Prof. Dr.
Role: STUDY_CHAIR
Klinikum Hanau GmbH
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Klinikum Hanau GmbH, Gefaesschirurgie
Hanau, Hesse, Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Bellon JM, Bujan J, Contreras LA, Hernando A, Jurado F. Similarity in behavior of polytetrafluoroethylene (ePTFE) prostheses implanted into different interfaces. J Biomed Mater Res. 1996 May;31(1):1-9. doi: 10.1002/(SICI)1097-4636(199605)31:13.0.CO;2-S.
Carney WI Jr, Lilly MP. Intraoperative evaluation of PTFE, Dacron and autogenous vein as carotid patch materials. Ann Vasc Surg. 1987 Dec;1(5):583-6. doi: 10.1016/S0890-5096(06)61445-3.
Zdrahala RJ. Small caliber vascular grafts. Part I: state of the art. J Biomater Appl. 1996 Apr;10(4):309-29. doi: 10.1177/088532829601000402.
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 Nov;44(5):1002-1009; discussion 1009. doi: 10.1016/j.jvs.2006.06.039. Epub 2006 Oct 3.
Miller CM, Sangiolo P, Jacobson JH 2nd. Reduced anastomotic bleeding using new sutures with a needle-suture diameter ratio of one. Surgery. 1987 Feb;101(2):156-60.
Citrin P, Doscher W, Wise L, Margolis IB. Control of needle hole bleeding with ethyl-cyanoacrylate glue (Krazy Glue). J Vasc Surg. 1985 May;2(3):488-90. doi: 10.1067/mva.1985.avs0020488.
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 Mar;125(3):284-7. doi: 10.1016/0002-9610(73)90042-1. No abstract available.
Hatsuoka M, Seiki M, Sasaki K, Kashii A. Hemostatic effects of microfibrillar collagen hemostat (MCH) in experimental coagulopathy model and its mechanism of hemostasis. Thromb Res. 1986 May 1;42(3):407-12. doi: 10.1016/0049-3848(86)90269-0. No abstract available.
Silverstein ME, Keown K, Owen JA, Chvapil M. Collagen fibers as a fleece hemostatic agent. J Trauma. 1980 Aug;20(8):688-94. doi: 10.1097/00005373-198008000-00010.
Czerny M, Verrel F, Weber H, Muller 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 (Torino). 2000 Aug;41(4):553-7.
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 May;27(5):549-52. doi: 10.1016/j.ejvs.2004.01.018.
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 Sep;30(3):461-6. doi: 10.1016/s0741-5214(99)70073-x.
Taylor LM Jr, 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 Oct;38(4):766-71. doi: 10.1016/s0741-5214(03)00474-9.
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 Mar;137(3):326-31; discussion 332. doi: 10.1001/archsurg.137.3.326.
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 Oct;13 Suppl 1(Suppl 1):S89-96. doi: 10.1007/s00586-004-0727-z. Epub 2004 Jun 22.
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 Sep;17(17):1733-8. doi: 10.1016/0142-9612(96)87654-x.
Uranüs, S. ; Pfeifer, J. ; Alimoglu, O. ; Özmen, T. Laparoskopische Eingriffe an der Milz Chir Gastroenterol 2004;20(Suppl.2):35-41 (DOI:10.1159/000083352)
Heidemann D, Hartenstein B. [Effect of local hemostyptics on human gingiva fibroblasts in culture]. Dtsch Z Mund Kiefer Gesichtschir. 1989 May-Jun;13(3):226-9. German.
Haussmann P, Mergard UE, Kohnlein HE. [Effect of various hemostatics. Animal experiment studies]. Fortschr Med. 1974 May 9;92(13):579-80. No abstract available. German.
Bauer P, Kohne K. Evaluation of experiments with adaptive interim analyses. Biometrics. 1994 Dec;50(4):1029-41.
Jensen LP, Lepantalo M, Fossdal JE, Roder OC, Jensen BS, Madsen MS, Grenager O, Fasting H, Myhre HO, Baekgaard N, Nielsen OM, Helgstrand U, Schroeder TV. Dacron or PTFE for above-knee femoropopliteal bypass. a multicenter randomised study. Eur J Vasc Endovasc Surg. 2007 Jul;34(1):44-9. doi: 10.1016/j.ejvs.2007.01.016. Epub 2007 Apr 2.
Ballotta E, Renon L, Toffano M, Da Giau G. Prospective randomized study on bilateral above-knee femoropopliteal revascularization: Polytetrafluoroethylene graft versus reversed saphenous vein. J Vasc Surg. 2003 Nov;38(5):1051-5. doi: 10.1016/s0741-5214(03)00608-6.
Devine C, McCollum C; North West Femoro-Popliteal Trial Participants. Heparin-bonded Dacron or polytetrafluorethylene for femoropopliteal bypass: five-year results of a prospective randomized multicenter clinical trial. J Vasc Surg. 2004 Nov;40(5):924-31. doi: 10.1016/j.jvs.2004.08.033.
Eiberg JP, Roder O, Stahl-Madsen M, Eldrup N, Qvarfordt P, Laursen A, Greve M, Florenes T, Nielsen OM, Seidelin C, Vestergaard-Andersen T, Schroeder TV. Fluoropolymer-coated dacron versus PTFE grafts for femorofemoral crossover bypass: randomised trial. Eur J Vasc Endovasc Surg. 2006 Oct;32(4):431-8. doi: 10.1016/j.ejvs.2006.04.018. Epub 2006 Jun 27.
Kapfer X, Meichelboeck W, Groegler FM. Comparison of carbon-impregnated and standard ePTFE prostheses in extra-anatomical anterior tibial artery bypass: a prospective randomized multicenter study. Eur J Vasc Endovasc Surg. 2006 Aug;32(2):155-68. doi: 10.1016/j.ejvs.2005.12.015. Epub 2006 Apr 17.
Klinkert P, Schepers A, Burger DH, van Bockel JH, Breslau PJ. Vein versus polytetrafluoroethylene in above-knee femoropopliteal bypass grafting: five-year results of a randomized controlled trial. J Vasc Surg. 2003 Jan;37(1):149-55. doi: 10.1067/mva.2002.86.
Qerimi B, Baumann P, Husing J, Knaebel HP, Schumacher H. Collagen hemostat significantly reduces time to hemostasis compared with cellulose: COBBANA, a single-center, randomized trial. Am J Surg. 2013 Jun;205(6):636-41. doi: 10.1016/j.amjsurg.2012.05.033. Epub 2013 Jan 17.
Baumann P, Schumacher H, Husing J, Luntz S, Knaebel HP. A randomized, controlled, prospective trial to evaluate the haemostatic effect of Lyostypt versus Surgicel in arterial bypass anastomosis: "COBBANA" trial. Trials. 2009 Sep 29;10:91. doi: 10.1186/1745-6215-10-91.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AAG-G-H-0803
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.