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

Use of Tachosil® for Lymph Sealing During Surgery. A Non-Interventional Study

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

Study Overview

• Status: Completed
• Conditions: Lymph Node Resection
• Intervention / Treatment: Other: TachoSil®

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 233

Contacts and Locations

Study Locations

• Germany
  • Greifswald, Germany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Stationary patients in whom a lymph node resection was planned to be performed

Description

Inclusion Criteria:

• Stationary patients undergoing lymph node resection.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TachoSil®; TachoSil®, sterile absorbable patch, topical application, used during surgery in participants who had lymphadenectomy according to the Summary of Product Characteristics.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants With Post-Operative Seroma Formation Over Time as Determined at Hospital Discharge	Up to 50 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of TachoSil® by the Surgeon With Respect to Handling Using a 10-Point Numerical Rating Scale	The surgeon evaluated handling of TachoSil® using a 10-point scale where: 1=very good to 10=very poor.	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	The surgeon evaluated Utility in Operation of TachoSil® using a 10-point scale where: 1=very useful to 10=completely useless.	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	The surgeon evaluated Satisfaction in Operation of TachoSil® using a 10-point scale where: 1=very satisfied to 10=totally unsatisfied.	Peri- and post-surgery (Up to 50 Days)
Percentage of Participants With at Least One Drainage Inserted	The total number of participants where at least one drainage was used during the operation.	Baseline (Day of Surgery)
Percentage of Participants With Change in Length of Drainage Stay and Drainage Volume		Up to 50 Days
Length of Hospital and ICU Stay	Length of stay includes time (days) spent in the intensive care unit (ICU) and normal hospital station.	Up to 50 Days
Percentage of Participants With Pharmacoeconomic Benefit Based on Savings of Operating Time	Pharmacoeconomic benefit was assessed by the surgeon based on savings/shortening of operating time in minutes.	Peri- and post-surgery (Up to 50 Days)
Percentage of Participants With Pharmacoeconomic Benefit Based on Shortening of Hospital Stay	Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on shortening of hospital stay in days.	Up to 50 Days
Percentage of Participants With Pharmacoeconomic Benefit in Shortening of Time Spent in ICU	Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on shortening of time spent in ICU in days.	Up to 50 Days
Percentage of Participants With Pharmacoeconomic Benefit Based on Drainage Time Reduced	Pharmacoeconomic evaluation as assessed by the surgeon at hospital discharge based on drainage time reduced in days.	Up to 50 Days
Percentage of Participants With Pharmacoeconomic Benefit Based on Drainage Volume Reduced	Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on the drainage volume reduced in milliliters.	Up to 50 Days
Percentage of Participants With Post-Operative Complications and Adverse Events	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.	Up to 50 Days

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Medical Director, Takeda Pharma Vertrieb GmbH & Co. KG

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: July 19, 2013
• First Submitted That Met QC Criteria: August 8, 2013
• First Posted (ESTIMATE): August 12, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): December 19, 2016
• Last Update Submitted That Met QC Criteria: October 26, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: TC-2402-401-DE; U1111-1142-0279 (REGISTRY: WHO)