Hemostatic Patch/Collagen Sealant and Polyethylene Glycol (Hemopatch) in the Postoperative of the Thyroidectomy.
NCT ID: NCT05103956
Last Updated: 2021-11-17
Study Results
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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UNKNOWN
108 participants
OBSERVATIONAL
2021-10-01
2022-04-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Group A (Study Group)
HEMOPATCH® (Sealing / hemostatic patch of collagen and e polyethylene glycol)
No interventions assigned to this group
Group B (Control Group)
No hemostatic or the standard (ligatures and oxidized cellulose regenerated).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Indication of total thyroidectomy due to multinodular goiter.
* Accept to enter the study and sign the informed consent.
* Patient willing and able to complete clinical trial procedures, as described described in the protocol.
Exclusion Criteria
* Patients with surgical indication for hemithyroidectomy or subtotal thyroidectomy (eg unilateral nodular goiters).
* Multinodular goiter with high suspicion or preoperative diagnosis of cancer (Bethesda V and VI and / or infiltration of neighboring structures on imaging tests).
* Known allergy or hypersensitivity to a component of the Hemopatch® investigational treatments, riboflavin, or bovine proteins.
* Concurrent or prior therapy with systemic pharmacological agents that promote blood clotting, including, but not limited to, tranexamic acid, activated factor VII, fibrinogen, and aprotinin.
* Pregnancy or breastfeeding.
* Refuse to enter the study and sign the informed consent.
* Not agreeing to carry out all the planned follow-up.
* Concurrent participation in another clinical trial with a medical device or drug or with interfering endpoints Inability to understand the nature and scope of the trial and the required procedures.
* Persistent major bleeding after primary hemostasis.
* Infection of the surgical area.
18 Years
ALL
No
Sponsors
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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
OTHER
Responsible Party
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Principal Investigators
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Juan Manuel Martos Martínez
Role: PRINCIPAL_INVESTIGATOR
Hospitales Universitarios Virgen del Rocío
Locations
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Hospital Universitario Virgen del Rocío
Seville, , Spain
Countries
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Central Contacts
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Facility Contacts
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Juan Manuel Martos Martinez
Role: primary
Carlos García Pérez
Role: backup
Other Identifiers
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TIROPATCH
Identifier Type: -
Identifier Source: org_study_id