Trial Outcomes & Findings for Use of Tachosil® for Lymph Sealing During Surgery (NCT NCT01920958)

NCT ID: NCT01920958

Last Updated: 2016-12-19

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 233 participants
• Primary outcome timeframe: Up to 50 Days
• Results posted on: 2016-12-19

Participant Flow

The study was conducted at 39 investigative sites in Germany from 30 September 2012 to 27 March 2014.

Collection of information of routine use of TachoSil® in participants who had lymph node surgery.

Participant milestones

Measure	TachoSil® TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
Overall Study STARTED	233
Overall Study COMPLETED	228
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	TachoSil® TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
Overall Study Did Not Fulfill Inclusion Criteria	5

Baseline Characteristics

Use of Tachosil® for Lymph Sealing During Surgery

Baseline characteristics by cohort

Measure	TachoSil® n=228 Participants TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
Age, Continuous	63.6 years STANDARD_DEVIATION 10.82 • n=5 Participants
Sex/Gender, Customized Female	110 participants n=5 Participants
Sex/Gender, Customized Male	111 participants n=5 Participants
Sex/Gender, Customized Missing	7 participants n=5 Participants
Region of Enrollment Germany	228 participants n=5 Participants
Height	169.9 cm STANDARD_DEVIATION 9.07 • n=5 Participants
Weight	79.6 kg STANDARD_DEVIATION 15.84 • n=5 Participants
Body Mass Index (BMI)	27.55 kg/m^2 STANDARD_DEVIATION 5.092 • n=5 Participants

PRIMARY outcome

Timeframe: Up to 50 Days

Population: Intent-to-treat population consisted of all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery.

Outcome measures

Measure	TachoSil® n=228 Participants TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
Percentage of Participants With Post-Operative Seroma Formation Over Time as Determined at Hospital Discharge	2.63 percentage of participants

SECONDARY outcome

Timeframe: Peri- and post-surgery (Up to 50 Days)

Population: Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis.

The surgeon evaluated handling of TachoSil® using a 10-point scale where: 1=very good to 10=very poor.

Outcome measures

Measure	TachoSil® n=225 Participants TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
Assessment of TachoSil® by the Surgeon With Respect to Handling Using a 10-Point Numerical Rating Scale	2.2 score on a scale Standard Deviation 0.98

SECONDARY outcome

Timeframe: Peri- and post-surgery (Up to 50 Days)

Population: Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis.

The surgeon evaluated Utility in Operation of TachoSil® using a 10-point scale where: 1=very useful to 10=completely useless.

Outcome measures

Measure	TachoSil® n=225 Participants TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
Assessment of TachoSil® by the Surgeon With Respect to Utility in Operation Using a 10-Point Numerical Rating Scale	2.3 score on a scale Standard Deviation 1.25

SECONDARY outcome

Timeframe: Peri- and post-surgery (Up to 50 Days)

Population: Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis.

The surgeon evaluated Satisfaction in Operation of TachoSil® using a 10-point scale where: 1=very satisfied to 10=totally unsatisfied.

Outcome measures

Measure	TachoSil® n=225 Participants TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
Assessment of TachoSil® by the Surgeon With Respect to Satisfaction Using a 10-Point Numerical Rating Scale	2.3 score on a scale Standard Deviation 1.42

SECONDARY outcome

Timeframe: Baseline (Day of Surgery)

Population: Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis.

The total number of participants where at least one drainage was used during the operation.

Outcome measures

Measure	TachoSil® n=228 Participants TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
Percentage of Participants With at Least One Drainage Inserted	81.14 percentage of participants

SECONDARY outcome

Timeframe: Up to 50 Days

Population: Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis.

Outcome measures

Measure	TachoSil® n=185 Participants TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
Percentage of Participants With Change in Length of Drainage Stay and Drainage Volume Change in Length of Drainage Stay	48.65 percentage of participants
Percentage of Participants With Change in Length of Drainage Stay and Drainage Volume Change in Drainage Volume	57.84 percentage of participants

SECONDARY outcome

Timeframe: Up to 50 Days

Population: Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis.

Length of stay includes time (days) spent in the intensive care unit (ICU) and normal hospital station.

Outcome measures

Measure	TachoSil® n=228 Participants TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
Length of Hospital and ICU Stay Hospital Stay (n=225)	12.2 days Standard Deviation 6.57
Length of Hospital and ICU Stay ICU Stay (n=100)	2.8 days Standard Deviation 1.91

SECONDARY outcome

Timeframe: Peri- and post-surgery (Up to 50 Days)

Population: ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.

Pharmacoeconomic benefit was assessed by the surgeon based on savings/shortening of operating time in minutes.

Outcome measures

Measure	TachoSil® n=228 Participants TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
Percentage of Participants With Pharmacoeconomic Benefit Based on Savings of Operating Time	17.98 percentage of participants

SECONDARY outcome

Timeframe: Up to 50 Days

Population: ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.

Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on shortening of hospital stay in days.

Outcome measures

Measure	TachoSil® n=228 Participants TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
Percentage of Participants With Pharmacoeconomic Benefit Based on Shortening of Hospital Stay	27.19 percentage of participants

SECONDARY outcome

Timeframe: Up to 50 Days

Population: ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.

Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on shortening of time spent in ICU in days.

Outcome measures

Measure	TachoSil® n=228 Participants TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
Percentage of Participants With Pharmacoeconomic Benefit in Shortening of Time Spent in ICU	8.77 percentage of participants

SECONDARY outcome

Timeframe: Up to 50 Days

Population: ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.

Pharmacoeconomic evaluation as assessed by the surgeon at hospital discharge based on drainage time reduced in days.

Outcome measures

Measure	TachoSil® n=228 Participants TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
Percentage of Participants With Pharmacoeconomic Benefit Based on Drainage Time Reduced	35.96 percentage of participants

SECONDARY outcome

Timeframe: Up to 50 Days

Population: ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.

Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on the drainage volume reduced in milliliters.

Outcome measures

Measure	TachoSil® n=228 Participants TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
Percentage of Participants With Pharmacoeconomic Benefit Based on Drainage Volume Reduced	39.04 percentage of participants

SECONDARY outcome

Timeframe: Up to 50 Days

Population: ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.

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.

Outcome measures

Measure	TachoSil® n=228 Participants TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
Percentage of Participants With Post-Operative Complications and Adverse Events Postoperative Complications	18.42 percentage of participants
Percentage of Participants With Post-Operative Complications and Adverse Events Adverse Events	13.60 percentage of participants

Adverse Events

TachoSil®

Serious events: 7 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Measure	TachoSil® n=228 participants at risk TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
Infections and infestations Groin abscess	0.44% 1/228 • Up to 30 days At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.88% 2/228 • Up to 30 days At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Seroma	0.44% 1/228 • Up to 30 days At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.44% 1/228 • Up to 30 days At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.3% 3/228 • Up to 30 days At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Vascular disorders Lymphocele	0.88% 2/228 • Up to 30 days At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Other adverse events

Measure	TachoSil® n=228 participants at risk TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
Vascular disorders Lymphocele	11.0% 25/228 • Up to 30 days At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Additional Information

Medical Director, Clinical Science

Takeda

Phone: +1-877-825-3327

Email: clinicaltrialregistry@tpna.com

Results disclosure agreements

• Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
• Publication restrictions are in place

Restriction type: OTHER