Haemostasis Clinical Trial
Official title:
Assessment of Long-term Effects of Intraoperative Use of a Carrier-bound Fibrin Sealant (TachoSil®). We Had to Continue to Use it?
NCT number | NCT05986201 |
Other study ID # | IDC-003 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 1, 2016 |
Est. completion date | June 1, 2023 |
Verified date | August 2023 |
Source | University of Catania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | June 1, 2023 |
Est. primary completion date | May 1, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 32 Years to 87 Years |
Eligibility | Inclusion Criteria: - type of surgery, indication for surgery, type of disease Exclusion Criteria: - dead patients, not available on call. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Catania |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 10 years |
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