Assessment of Long-term Effects of Tachosil

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.

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Key information

Conditions

Fibrin Sealant Haemostasis

Age range

32 year–87 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

type of surgery, indication for surgery, type of disease

Exclusion criteria

dead patients, not available on call.

Treatment and study plan

TachoSil®

Device

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.

Other names: haemostatic tissue sealant, carrier-bound fibrin sealant

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Catania

Other

Registry information

Official study title

Assessment of Long-term Effects of Intraoperative Use of a Carrier-bound Fibrin Sealant (TachoSil®). We Had to Continue to Use it?

Important dates

Study start: 2016
Primary completion: 2023
Study completion: 2023
First posted: Aug 14, 2023
Registry last updated: Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed