Greifswald, Germany
Completed
NCT Number: NCT01920958
Use of Tachosil® for Lymph Sealing During Surgery
The purpose of this study is to describe effectiveness and reliability of TachoSil® in lymph sealing after lymphadenectomy.
Completed
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Stationary patients undergoing lymph node resection.
Exclusion criteria
- Contraindications, such as hypersensitivity to the active pharmaceutical ingredient or to another ingredient.
Treatment and study plan
TachoSil®
OtherTachoSil® 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.
Primary outcomes
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Percentage of Participants With Post-Operative Seroma Formation Over Time as Determined at Hospital Discharge
Time frame: Up to 50 Days
Secondary outcomes
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Assessment of TachoSil® by the Surgeon With Respect to Handling Using a 10-Point Numerical Rating Scale
Time frame: Peri- and post-surgery (Up to 50 Days)
The surgeon evaluated handling of TachoSil® using a 10-point scale where: 1=very good to 10=very poor.
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Assessment of TachoSil® by the Surgeon With Respect to Utility in Operation Using a 10-Point Numerical Rating Scale
Time frame: Peri- and post-surgery (Up to 50 Days)
The surgeon evaluated Utility in Operation of TachoSil® using a 10-point scale where: 1=very useful to 10=completely useless.
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Assessment of TachoSil® by the Surgeon With Respect to Satisfaction Using a 10-Point Numerical Rating Scale
Time frame: Peri- and post-surgery (Up to 50 Days)
The surgeon evaluated Satisfaction in Operation of TachoSil® using a 10-point scale where: 1=very satisfied to 10=totally unsatisfied.
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Percentage of Participants With at Least One Drainage Inserted
Time frame: Baseline (Day of Surgery)
The total number of participants where at least one drainage was used during the operation.
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Percentage of Participants With Change in Length of Drainage Stay and Drainage Volume
Time frame: Up to 50 Days
-
Length of Hospital and ICU Stay
Time frame: Up to 50 Days
Length of stay includes time (days) spent in the intensive care unit (ICU) and normal hospital station.
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Percentage of Participants With Pharmacoeconomic Benefit Based on Savings of Operating Time
Time frame: Peri- and post-surgery (Up to 50 Days)
Pharmacoeconomic benefit was assessed by the surgeon based on savings/shortening of operating time in minutes.
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Percentage of Participants With Pharmacoeconomic Benefit Based on Shortening of Hospital Stay
Time frame: Up to 50 Days
Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on shortening of hospital stay in days.
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Percentage of Participants With Pharmacoeconomic Benefit in Shortening of Time Spent in ICU
Time frame: Up to 50 Days
Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on shortening of time spent in ICU in days.
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Percentage of Participants With Pharmacoeconomic Benefit Based on Drainage Time Reduced
Time frame: Up to 50 Days
Pharmacoeconomic evaluation as assessed by the surgeon at hospital discharge based on drainage time reduced in days.
-
Percentage of Participants With Pharmacoeconomic Benefit Based on Drainage Volume Reduced
Time frame: Up to 50 Days
Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on the drainage volume reduced in milliliters.
-
Percentage of Participants With Post-Operative Complications and Adverse Events
Time frame: Up to 50 Days
An Adverse Event (AE) is defined as any untoward medical occurrence in a participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Sponsors and collaborators
Lead sponsor
Takeda
Industry
Registry information
Official study title
Use of Tachosil® for Lymph Sealing During Surgery. A Non-Interventional Study
Acronym: SEAL
Important dates
- Study start
- 2012
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Aug 12, 2013
- Registry last updated
- Dec 19, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.