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Hemostatic Patch/Collagen Sealant and Polyethylene Glycol (Hemopatch) in the Postoperative of the Thyroidectomy.

Goiter Clinical Trial

Official title:
Regular Treatment Versus Hemostatic Patch/Collagen Sealant and Polyethylene Glycol (Hemopatch) in the Immediate Postoperative of the Thyroidectomy, Unicentric Study, Non-inferiority, Open and Randomized (Tiropatch Study)

Clinical Trial Summary

Observational study with non-inferiority, prospective, randomized (1: 1) and open-label medical device. The study has 2 treatment groups (HEMOPATCH® versus standard hemostasis).

Clinical Trial Description

The main objective is to determine if there is a reduction in the volume of exudate in the surgical bed with the application of the collagen and polyethylene glycol hemostatic agent. The present study includes patients undergoing total thyroidectomy for multinodular goiter in the Endocrine Surgery Unit of the Virgen del Rocío University Hospital. The estimated sample calculation of patients enrolled in the study is 108 (2 groups, 1:1 ratio). The patients don´t know what type of hemostatic the patients are going to receive (single blind). The duration of patient follow-up will be 30 +/- 10 days after surgery. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05103956
Study type Observational
Source Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Contact Juan Manuel Martos Martínez
Phone 955 01 20 00
Email jmmartos66@gmail.com
Status Recruiting
Phase
Start date October 1, 2021
Completion date April 1, 2022
View Details
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