Clinical trial NCT05103956: Hemostatic Patch/Collagen Sealant and Polyethylene Glycol (Hemopatch) in the Postoperative of the Thyroidectomy.
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Goiter
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Criteria to be verified during surgery (Intraoperative exclusion criteria):

* Persistent major bleeding after primary hemostasis.
* Infection of the surgical area.

Primary outcomes:
measure: Rate of changes in the exudate volume of the surgical bed with the application of the hemostatic agent of collagen and polyethylene glycol.
timeFrame: Up to 18 hours.
Secondary outcomes:
measure: 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.
timeFrame: Up to 4 weeks.
measure: 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.
timeFrame: Up to 4 weeks.
measure: Rate of improvement in postoperative complications of thyroidectomy after the application of the collagen and polyethylene glycol hemostatic agent.
timeFrame: Up to 4 weeks.
measure: Incidence rate of adverse effects after the use of the collagen and polyethylene glycol hemostatic agent in thyroid surgery.
timeFrame: Up to 24 weeks.
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
Study officials:
affiliation: Hospitales Universitarios Virgen del Rocío
name: Juan Manuel Martos Martínez
role: PRINCIPAL_INVESTIGATOR
References: