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Assessment of Long-term Effects of Tachosil

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05986201
Enrollment
40
Registered
2023-08-14
Start date
2016-02-01
Completion date
2023-06-01
Last updated
2023-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibrin Sealant, Haemostasis

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.

Interventions

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.

Sponsors

University of Catania
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
32 Years to 87 Years

Inclusion criteria

* type of surgery, indication for surgery, type of disease

Exclusion criteria

* dead patients, not available on call.

Design outcomes

Primary

MeasureTime frameDescription
fibrotic reaction10 yearsThe 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026