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

Aesculap

Status and phase: Completed; Phase 4

Conditions: Hemostasis; Peripheral Vascular Diseases

Treatments: Device: Lyostypt®; Procedure: Surgicel®; Device: Lyostypt® AND Surgicel®

Study type: Interventional

Funder types: Industry

Identifiers

NCT00837954

AAG-G-H-0803

Details and patient eligibility

About

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®

Full 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).

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

1

Active Comparator group

Description:

distal Anastomosis Lyostypt®, proximal Anastomosis Surgicel®

Treatment:

Device: Lyostypt® AND Surgicel®

2

Active Comparator group

Description:

distal Anastomosis Surgicel®, proximal Anastomosis Lyostypt®

Treatment:

Device: Lyostypt® AND Surgicel®

3

Active Comparator group

Description:

distal and proximal Anastomosis Lyostypt®

Treatment:

Device: Lyostypt®

4

Active Comparator group

Description:

distal and proximal Anastomosis Surgicel®

Treatment:

Procedure: Surgicel®