Trial to Evaluate the Hemostatic Effect of Lyostypt® Versus Surgicel® in Arterial Bypass Anastomosis (NCT00837954) | Clinical Trial Compass
CompletedPhase 4
Trial to Evaluate the Hemostatic Effect of Lyostypt® Versus Surgicel® in Arterial Bypass Anastomosis
Germany32 participantsStarted 2009-02
Plain-language 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®
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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