Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-01 @ 11:31 AM
Study NCT ID:
NCT05103956
Status:
UNKNOWN
Last Update Posted:
2021-11-17
First Post:
2021-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemostatic Patch/Collagen Sealant and Polyethylene Glycol (Hemopatch) in the Postoperative of the Thyroidectomy.
Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Organization:
Study Overview
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)
Status:
UNKNOWN
Status Verified Date:
2021-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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).
Detailed 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: