Assessment of Long-term Effects of Tachosil

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05986201
• Other study ID #: IDC-003
• Status: Completed
• Start date: February 1, 2016
• Est. completion date: June 1, 2023

Study information

• Verified date: August 2023
• Source: University of Catania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 1, 2023
• Est. primary completion date: May 1, 2023
• 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.

Related Conditions & MeSH terms

• Haemostasis

Intervention

Device:
• TachoSil®
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Catania

Outcome

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