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

Study Overview
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Brief Summary
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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®

Detailed Description
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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).

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

Conditions
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Peripheral Vascular Diseases, Hemostasis

Intervention / Treatment
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* Device: Lyostypt® AND Surgicel®
* Device: Lyostypt®
* Procedure: Surgicel®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>distal Anastomosis Lyostypt®, proximal Anastomosis Surgicel® | Device: Lyostypt® AND Surgicel®<br>* 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.<br>* Other names: Surgicel®;|
| Active Comparator: 2<br>distal Anastomosis Surgicel®, proximal Anastomosis Lyostypt® | Device: Lyostypt® AND Surgicel®<br>* 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.<br>* Other names: Surgicel®;|
| Active Comparator: 3<br>distal and proximal Anastomosis Lyostypt® | Device: Lyostypt®<br>* 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.<br>|
| Active Comparator: 4<br>distal and proximal Anastomosis Surgicel® | Procedure: Surgicel®<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to hemostasis |  | Minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Complications |  | 30 days after surgery | 
| Postoperative Mortality |  | 30 days after surgery | 
| Efficacy Rating of Study Device evaluated by Surgeon |  | intraoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTFE Graft, Suture Hole Bleeding, Hemostasis