Use of Tachosil® for Lymph Sealing During Surgery (SEAL)

Takeda

Status: Completed

Conditions: Lymph Node Resection

Treatments: Other: TachoSil®

Study type: Observational

Funder types: Industry

Identifiers

NCT01920958

U1111-1142-0279 (Registry Identifier)

TC-2402-401-DE

Details and patient eligibility

About

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

Full description

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.

Enrollment: 233 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stationary patients undergoing lymph node resection.

Exclusion criteria

• Contraindications, such as hypersensitivity to the active pharmaceutical ingredient or to another ingredient.

Trial design

233 participants in 1 patient group

TachoSil®

Description:

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

Treatment:

Other: TachoSil®