Use of Tachosil® for Lymph Sealing During Surgery
SEAL
2 other identifiers
observational
233
1 country
1
Brief Summary
The purpose of this study is to describe effectiveness and reliability of TachoSil® in lymph sealing after lymphadenectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 19, 2013
CompletedFirst Posted
Study publicly available on registry
August 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedResults Posted
Study results publicly available
December 19, 2016
CompletedDecember 19, 2016
October 1, 2016
1.5 years
July 19, 2013
May 7, 2015
October 26, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Post-Operative Seroma Formation Over Time as Determined at Hospital Discharge
Up to 50 Days
Secondary Outcomes (12)
Assessment of TachoSil® by the Surgeon With Respect to Handling Using a 10-Point Numerical Rating Scale
Peri- and post-surgery (Up to 50 Days)
Assessment of TachoSil® by the Surgeon With Respect to Utility in Operation Using a 10-Point Numerical Rating Scale
Peri- and post-surgery (Up to 50 Days)
Assessment of TachoSil® by the Surgeon With Respect to Satisfaction Using a 10-Point Numerical Rating Scale
Peri- and post-surgery (Up to 50 Days)
Percentage of Participants With at Least One Drainage Inserted
Baseline (Day of Surgery)
Percentage of Participants With Change in Length of Drainage Stay and Drainage Volume
Up to 50 Days
- +7 more secondary outcomes
Study Arms (1)
TachoSil®
TachoSil®, sterile absorbable patch, topical application, used during surgery in participants who had lymphadenectomy according to the Summary of Product Characteristics.
Interventions
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.
Eligibility Criteria
Stationary patients in whom a lymph node resection was planned to be performed
You may qualify if:
- Stationary patients undergoing lymph node resection.
You may not qualify if:
- Contraindications, such as hypersensitivity to the active pharmaceutical ingredient or to another ingredient.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (1)
Unknown Facility
Greifswald, Germany
MeSH Terms
Interventions
Results Point of Contact
- Title
- Medical Director, Clinical Science
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Medical Director
Takeda Pharma Vertrieb GmbH & Co. KG
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2013
First Posted
August 12, 2013
Study Start
September 1, 2012
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
December 19, 2016
Results First Posted
December 19, 2016
Record last verified: 2016-10