Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01920958
Recruitment Status : Completed
First Posted : August 12, 2013
Results First Posted : December 19, 2016
Last Update Posted : December 19, 2016
Sponsor:
Information provided by (Responsible Party):
Takeda

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

Condition or disease Intervention/treatment
Lymph Node Resection 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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 233 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Tachosil® for Lymph Sealing During Surgery. A Non-Interventional Study
Study Start Date : September 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Drug Information available for: TachoSil

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.




Primary Outcome Measures :
  1. Percentage of Participants With Post-Operative Seroma Formation Over Time as Determined at Hospital Discharge [ Time Frame: Up to 50 Days ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Percentage of Participants With Change in Length of Drainage Stay and Drainage Volume [ Time Frame: Up to 50 Days ]
  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Stationary patients in whom a lymph node resection was planned to be performed
Criteria

Inclusion Criteria:

  • Stationary patients undergoing lymph node resection.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920958


Locations
Layout table for location information
Germany
Greifswald, Germany
Sponsors and Collaborators
Takeda
Investigators
Layout table for investigator information
Study Director: Medical Director Takeda Pharma Vertrieb GmbH & Co. KG

Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01920958     History of Changes
Other Study ID Numbers: TC-2402-401-DE
U1111-1142-0279 ( Registry Identifier: WHO )
First Posted: August 12, 2013    Key Record Dates
Results First Posted: December 19, 2016
Last Update Posted: December 19, 2016
Last Verified: October 2016