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

NCT05103956 | Unknown

• 1 other identifier: TIROPATCH
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

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).

Conditions

Goiter

Outcome Measures

Primary Outcomes (1)

• Rate of changes in the exudate volume of the surgical bed with the application of the hemostatic agent of collagen and polyethylene glycol.

  Fixed periods of time will be established to evaluate the exudate from the surgical bed. It will be evaluated 18 hours after surgery by cervical ultrasound.

  Up to 18 hours.

Secondary Outcomes (4)

• Rate of changes in the patient's symptoms in the postoperative period of thyroidectomy after the application of the hemostatic agent of collagen and polyethylene glycol.

  Up to 4 weeks.

• Improvement in patient satisfaction after the application of the collagen and polyethylene glycol hemostatic agent, in relation to the surgical experience in the postoperative period of thyroidectomy.

  Up to 4 weeks.

• Rate of improvement in postoperative complications of thyroidectomy after the application of the collagen and polyethylene glycol hemostatic agent.

  Up to 4 weeks.

• Incidence rate of adverse effects after the use of the collagen and polyethylene glycol hemostatic agent in thyroid surgery.

  Up to 24 weeks.

Study Arms (2)

Group A (Study Group)

HEMOPATCH® (Sealing / hemostatic patch of collagen and e polyethylene glycol)

Group B (Control Group)

No hemostatic or the standard (ligatures and oxidized cellulose regenerated).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The present study includes older patients who underwent total thyroidectomy for multinodular goiter in the Endocrine Surgery Unit of the Virgen del Rocío University Hospital. They must sign an informed consent and know the study procedures that are detailed in the protocol.

You may qualify if:

• Patients of legal age.
• 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.

You may not qualify if:

• Patients under 18 years of age.
• 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.

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

Study Sites (1)

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

RECRUITING

MeSH Terms

Conditions

Goiter

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Study Officials

• Juan Manuel Martos Martínez

  Hospitales Universitarios Virgen del Rocío

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Manuel Martos Martínez

CONTACT

955 01 20 00; jmmartos66@gmail.com

Carlos García Pérez

CONTACT

955 04 31 27; administracion.eecc.hvm.sspa@juntadeandalucia.es

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: November 2, 2021
• Study Start: October 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: November 17, 2021

Record last verified: 2021-10

Locations

ES (1)