---
title: Trial to Evaluate the Hemostatic Effect of Lyostypt® Versus Surgicel® in Arterial Bypass Anastomosis
nct_id: NCT00837954
overall_status: COMPLETED
phase: PHASE4
sponsor: Aesculap AG
study_type: INTERVENTIONAL
primary_condition: Peripheral Vascular Diseases
countries: Germany
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00837954.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00837954"
ct_last_update_post_date: 2015-05-28
last_seen_at: "2026-05-12T06:21:17.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Trial to Evaluate the Hemostatic Effect of Lyostypt® Versus Surgicel® in Arterial Bypass Anastomosis

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

**NCT ID:** [NCT00837954](https://clinicaltrials.gov/study/NCT00837954)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 32
- **Lead Sponsor:** Aesculap AG
- **Conditions:** Peripheral Vascular Diseases, Hemostasis
- **Start Date:** 2009-02
- **Completion Date:** 2010-04
- **CT.gov Last Update:** 2015-05-28

## Brief 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®

## Detailed 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).

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **1** (ACTIVE_COMPARATOR) — distal Anastomosis Lyostypt®, proximal Anastomosis Surgicel®
- **2** (ACTIVE_COMPARATOR) — distal Anastomosis Surgicel®, proximal Anastomosis Lyostypt®
- **3** (ACTIVE_COMPARATOR) — distal and proximal Anastomosis Lyostypt®
- **4** (ACTIVE_COMPARATOR) — distal and proximal Anastomosis Surgicel®

## Interventions

- **Lyostypt® AND Surgicel®** (DEVICE) — 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®** (DEVICE) — 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®** (PROCEDURE) — 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.

## Primary Outcomes

- **Time to hemostasis** _(time frame: Minutes)_

## Secondary Outcomes

- **Number of Complications** _(time frame: 30 days after surgery)_
- **Postoperative Mortality** _(time frame: 30 days after surgery)_
- **Efficacy Rating of Study Device evaluated by Surgeon** _(time frame: intraoperatively)_

## Locations (1)

- Klinikum Hanau GmbH, Gefaesschirurgie, Hanau, Hesse, Germany

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.klinikum hanau gmbh, gefaesschirurgie|hanau|hesse|germany` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT00837954*  
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