Assessment of Long-term Effects of Tachosil

NCT05986201 | Completed FDA Device

• 1 other identifier: IDC-003
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fibrin Sealant; Haemostasis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Device: TachoSil®

Interventions

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.

Also known as: haemostatic tissue sealant, carrier-bound fibrin sealant

40 patients

Eligibility Criteria

• Age: 32 Years - 87 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

There were 33 (82.5%) males and 7 (17.5%) females aged 32-87 years, with a mean age of 67.8 years. The indications for surgery were hepatocellular carcinoma 23 (57.5%), hydatid cyst 3 (7.5%), hepatic adenoma 1 (2.5%), hepatic trauma 2 (5.0%), cholecystitis 2 (5.0%), 3 (7.5%), splenic rupture or bleeding for trauma 1 (2.5%), neuroendocrine tumour and trauma of the pancreas 1 (2.5%), peptic gastric ulcer 3 (7.5%), and colon cancer 1 (2.5%). There were 29 hepatic surgical procedures: 4 left lobectomies, 2 right hepatectomies, 9 segmentectomies, 2 bi-segmentectomies, 8 limited resections, and 1 enucleation following the Couinaud classification (23); 2 partial cystopericistectomies, 1 simple suture of the traumatic lobe of the liver after biliary check; 2 cholecystectomies, 3 total splenectomies, 1 enucleation of tumour of the tail of the pancreas, 1 haemostasis of the traumatic tail of the pancreas, 3 sutures of ulcer of the stomach, and 1 colon cancer resection.

You may qualify if:

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

You may not qualify if:

• dead patients, not available on call.

Sponsors & Collaborators

• University of Catania: lead

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 14, 2023
• Study Start: February 1, 2016
• Primary Completion: May 1, 2023
• Study Completion: June 1, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08