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Use of Tachosil® for Lymph Sealing During Surgery

NCT ID: NCT01920958

Last Updated: 2016-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

233 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-03-31

Brief Summary

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The purpose of this study is to describe effectiveness and reliability of TachoSil® in lymph sealing after lymphadenectomy.

Detailed Description

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The aim of this non-interventional study (NIS) was to collect further knowledge on the routine use of TachoSil ® in lymph node surgery where its sealing property helps to reduce the rate of postoperative complications, especially of seroma formation. Some data are already available from gynecology, urology and thoracic surgery.

Conditions

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Lymph Node Resection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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TachoSil®

TachoSil®, sterile absorbable patch, topical application, used during surgery in participants who had lymphadenectomy according to the Summary of Product Characteristics.

TachoSil®

Intervention Type OTHER

TachoSil® is a collagen sponge that is coated with the active substances human fibrinogen and human thrombin and that supports hemostasis and tissue sealing in surgery.

Interventions

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TachoSil®

TachoSil® is a collagen sponge that is coated with the active substances human fibrinogen and human thrombin and that supports hemostasis and tissue sealing in surgery.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Stationary patients undergoing lymph node resection.

Exclusion Criteria

* Contraindications, such as hypersensitivity to the active pharmaceutical ingredient or to another ingredient.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Takeda Pharma Vertrieb GmbH & Co. KG

Locations

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Greifswald, , Germany

Site Status

Countries

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Germany

Other Identifiers

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U1111-1142-0279

Identifier Type: REGISTRY

Identifier Source: secondary_id

TC-2402-401-DE

Identifier Type: -

Identifier Source: org_study_id