Fibrin SealantNCT05986201
Assessment of Long-term Effects of Tachosil
An observational study of Fibrin Sealant and Haemostasis, run by University of Catania.
Trial summary
This study aimed to analyse the long-term effects of a carrier-bound fibrin sealant (CBFS) after abdominal surgery by following up patients years after application. Read more about this study
- Who is it for?
- Ages 32 to 87 years
- Conditions the study is for
- Fibrin Sealant, Haemostasis
- What is being tested?
- TachoSil®
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2016to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 87 years
- All sexes
- Adult, Older adult
Study population: There were 33 (82.5%) males and 7 (17.5%) females aged 32-87 years, with a mean age of 67.8 years. The indications for surgery were hepatocellular carcinoma 23 (57.5%), hydatid cyst 3 (7.5%), hepatic adenoma 1 (2.5%), hepatic trauma 2 (5.0%), cholecystitis 2 (5.0%), 3 (7.5%), splenic rupture or bleeding for trauma 1 (2.5%), neuroendocrine tumour and trauma of the pancreas 1 (2.5%), peptic gastric ulcer 3 (7.5%), and colon cancer 1 (2.5%). There were 29 hepatic surgical procedures: 4 left lobectomies, 2 right hepatectomies, 9 segmentectomies, 2 bi-segmentectomies, 8 limited resections, and 1 enucleation following the Couinaud classification (23); 2 partial cystopericistectomies, 1 simple suture of the traumatic lobe of the liver after biliary check; 2 cholecystectomies, 3 total splenectomies, 1 enucleation of tumour of the tail of the pancreas, 1 haemostasis of the traumatic tail of the pancreas, 3 sutures of ulcer of the stomach, and 1 colon cancer resection.
Who may be able to join
- type of surgery, indication for surgery, type of disease
Who cannot join
- dead patients, not available on call.
About this study
Official title: Assessment of Long-term Effects of Intraoperative Use of a Carrier-bound Fibrin Sealant (TachoSil®). We Had to Continue to Use it?
This study aimed to analyse the long-term effects of a carrier-bound fibrin sealant (CBFS) after abdominal surgery by following up patients years after application.
- Conditions
- Fibrin Sealant, Haemostasis
- Being tested
- TachoSil®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TachoSil®Device
Also called haemostatic tissue sealant, carrier-bound fibrin sealant
TachoSil®, a carrier-bound fibrin sealant (CBFS), is a haemostatic tissue sealant composed of a collagen sponge, made from horse tendons, coated on one side with dried human fibrinogen and human thrombin.
| Study group | Role | What they receive |
|---|---|---|
| 40 patients | There were 33 (82.5%) males and 7 (17.5%) females aged 32-87 years, with a mean age of 67.8 years. Receives: Device: TachoSil® |
What is being measured
The primary outcome is the main question the study is designed to answer.
fibrotic reaction
The evaluation focused on individuation of the area treated with CBFS, comprehensive analysis of the dimensions of the area treated if visible, and evolution, focusing on the presence of fibrosis, sclerosis, collections, cysts, or pseudocysts. The formation of a fibrotic reaction was related to the presence of residual tissue on CT during follow-up.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Feb 2016
- Primary completion1 May 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrin SealantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isidoro Di Carlo, MD, PhD, FACS, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05986201
- Sponsor's protocol ID
- IDC-003
- Status last verified
- Aug 2023
- First submitted
- 2 Aug 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Long-term Effects of Intraoperative Use of a Carrier-bound Fibrin Sealant (TachoSil®). We Had to Continue to Use it?
- ClinicalTrials.gov ID
- NCT05986201
- Acronym / sponsor ID
- IDC-003
- Conditions
- Fibrin Sealant, Haemostasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to analyse the long-term effects of a carrier-bound fibrin sealant (CBFS) after abdominal surgery by following up patients years after application.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 40 patients | – | Device: TachoSil®There were 33 (82.5%) males and 7 (17.5%) females aged 32-87 years, with a mean age of 67.8 years. |
Who may qualify
- Ages
- 32 to 87 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- There were 33 (82.5%) males and 7 (17.5%) females aged 32-87 years, with a mean age of 67.8 years. The indications for surgery were hepatocellular carcinoma 23 (57.5%), hydatid cyst 3 (7.5%), hepatic adenoma 1 (2.5%), hepatic trauma 2 (5.0%), cholecystitis 2 (5.0%), 3 (7.5%), splenic rupture or bleeding for trauma 1 (2.5%), neuroendocrine tumour and trauma of the pancreas 1 (2.5%), peptic gastric ulcer 3 (7.5%), and colon cancer 1 (2.5%). There were 29 hepatic surgical procedures: 4 left lobectomies, 2 right hepatectomies, 9 segmentectomies, 2 bi-segmentectomies, 8 limited resections, and 1 enucleation following the Couinaud classification (23); 2 partial cystopericistectomies, 1 simple suture of the traumatic lobe of the liver after biliary check; 2 cholecystectomies, 3 total splenectomies, 1 enucleation of tumour of the tail of the pancreas, 1 haemostasis of the traumatic tail of the pancreas, 3 sutures of ulcer of the stomach, and 1 colon cancer resection.
Key inclusion criteria (1 listed)
- type of surgery, indication for surgery, type of disease
Key exclusion criteria (1 listed)
- dead patients, not available on call.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TachoSil®Also: haemostatic tissue sealant, carrier-bound fibrin sealantTachoSil®, a carrier-bound fibrin sealant (CBFS), is a haemostatic tissue sealant composed of a collagen sponge, made from horse tendons, coated on one side with dried human fibrinogen and human thrombin. | Device | 40 patients |
Primary outcome
fibrotic reaction
Time frame: 10 years
The evaluation focused on individuation of the area treated with CBFS, comprehensive analysis of the dimensions of the area treated if visible, and evolution, focusing on the presence of fibrosis, sclerosis, collections, cysts, or pseudocysts. The formation of a fibrotic reaction was related to the presence of residual tissue on CT during follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibrin Sealant and Haemostasis, run by University of Catania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fibrotic reaction (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.