NCT05103956

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

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
• Phase: —
• Study type: Observational
• Enrollment: 108 (estimated)
• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Goiter

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-04-01
• Completion: 2022-04-01
• First posted: 2021-11-02
• Last updated: 2021-11-17

Locations

1 site across 1 country: Spain