Assessment of Long-term Effects of Tachosil

Completed

• Conditions: Haemostasis; Fibrin Sealant
• Interventions: Device: TachoSil®

• Registration Number: NCT05986201
• Lead Sponsor: University of Catania

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-01
• Primary Completion: 2023-05-01
• Study Completion: 2023-06-01
• Status Verified: 2023-08
• Study First Submitted: 2023-08-02
• Study First Submitted QC: 2023-08-02
• Last Update Submitted: 2023-08-02
• Study First Posted: 2023-08-14
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• type of surgery, indication for surgery, type of disease

Exclusion Criteria

• dead patients, not available on call.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
40 patients	TachoSil®	There were 33 (82.5%) males and 7 (17.5%) females aged 32-87 years, with a mean age of 67.8 years.

Primary Outcome Measures

Name	Time	Method
fibrotic reaction	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.