Trial to Evaluate the Hemostatic Effect of Lyostypt® Versus Surgicel® in Arterial Bypass Anastomosis

Peripheral Vascular Diseases Clinical Trial

— COBBANA  

Official title:

Randomized, Controlled, Prospective Trial to Evaluate the Hemostatic Effect of Lyostypt® Versus Surgicel® in Arterial Bypass Anastomosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00837954
• Other study ID #: AAG-G-H-0803
• Status: Completed
• Phase: Phase 4
• First received: February 5, 2009
• Last updated: May 27, 2015
• Start date: February 2009
• Est. completion date: April 2010

Study information

• Verified date: May 2015
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The purpose of this trial is to demonstrate that the bleeding time of suture holes after construction of arterial bypass anastomosis is shorter after treatment with Lyostypt® than with Surgicel®

Description:

Hemostasis in peripheral vascular surgery is made more difficult by the need for direct arterial and arterial graft suturing as well as by systemic anticoagulation to prevent thrombosis during periods of vascular occlusion. Polytetrafluorethylene (PTFE) is one of the most frequently used graft materials for vascular replacement or bypass in the case when no autologous venae are available (1). However, the insufficient elasticity of PTFE and its porosity promote the development of suture hole bleeding (2,3) which can cause considerable loss of blood and prolongation of operations (2).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with an indication for a peripheral vascular reconstruction due to peripheral vascular disease (PVD) including femoro-femoral, femoro-popliteal and femoro-crural reconstructions or the need of a crossover including femoro-femoral or ilaco-femoro reconstruction.

• suture hole bleeding of peripheral arterial bypass anastomosis using PTFE graft prosthesis

• Written informed consent

Exclusion Criteria:

• Emergency surgery

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemostasis
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• 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.

Procedure:
• 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.

Locations

Country	Name	City	State
Germany	Klinikum Hanau GmbH, Gefaesschirurgie	Hanau	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Country where clinical trial is conducted

Germany, 

References & Publications (28)

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. — View Citation

Bauer P, Köhne K. Evaluation of experiments with adaptive interim analyses. Biometrics. 1994 Dec;50(4):1029-41. — View Citation

Baumann P, Schumacher H, Hüsing 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: 10.1186/174 — View Citation

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 May;31(1):1-9. — View Citation

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. — View Citation

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. — View Citation

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 (Torino). 2000 Aug;41(4):553-7. — View Citation

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. — View Citation

Eiberg JP, Røder O, Stahl-Madsen M, Eldrup N, Qvarfordt P, Laursen A, Greve M, Flörenes 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. Epub 2006 Jun 27. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Haussmann P, Mergard UE, Köhnlein HE. [Effect of various hemostatics. Animal experiment studies]. Fortschr Med. 1974 May 9;92(13):579-80. German. — View Citation

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. — View Citation

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. — View Citation

Jensen LP, Lepäntalo M, Fossdal JE, Røder 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. Epub 2007 Apr 2. — View Citation

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. — View Citation

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. Epub 2006 Apr 17. — View Citation

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. — View Citation

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. Epub 2006 Oct 3. — View Citation

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. — View Citation

Qerimi B, Baumann P, Hüsing 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. — View Citation

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:S89-96. Epub 2004 Jun 22. Review. — View Citation

Silverstein ME, Keown K, Owen JA, Chvapil M. Collagen fibers as a fleece hemostatic agent. J Trauma. 1980 Aug;20(8):688-94. — View Citation

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. — View Citation

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)

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. — View Citation

Zdrahala RJ. Small caliber vascular grafts. Part I: state of the art. J Biomater Appl. 1996 Apr;10(4):309-29. Review. — View Citation

* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to hemostasis		Minutes	No
Secondary	Number of Complications		30 days after surgery	Yes
Secondary	Postoperative Mortality		30 days after surgery	No
Secondary	Efficacy Rating of Study Device evaluated by Surgeon		intraoperatively	No