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

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status

Unknown

Conditions

Goiter

Study type

Observational

Funder types

Other

Identifiers

NCT05103956

TIROPATCH

Details and patient eligibility

About

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

Full 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.

Enrollment

108 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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):