Assessment of Long-term Effects of Tachosil

NCT ID: NCT05986201

Last Updated: 2023-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-01

Study Completion Date

2023-06-01

Brief Summary

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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

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Conditions

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Fibrin Sealant Haemostasis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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40 patients

There were 33 (82.5%) males and 7 (17.5%) females aged 32-87 years, with a mean age of 67.8 years.

TachoSil®

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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haemostatic tissue sealant carrier-bound fibrin sealant

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* dead patients, not available on call.
Minimum Eligible Age

32 Years

Maximum Eligible Age

87 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Catania

OTHER

Sponsor Role lead

Responsible Party

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Isidoro Di Carlo, MD, PhD, FACS

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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IDC-003

Identifier Type: -

Identifier Source: org_study_id

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