The Use of SupraThel 250 as a Novel Therapeutic Option for Mucosal Healing in Head and Neck Surgery

What this Trial Is About

Researchers are evaluating the use of SupraTHEL 250, a synthetic biodegradable membrane, for mucosal reconstruction in the head and neck region after tonsillectomy procedures. The study aims to compare healing with SupraTHEL 250 applied to the wound bed versus the usual care of leaving the wound bare. This phase 1 and 2 trial investigates whether SupraTHEL 250 can reduce pain and improve the healing process for patients with recurrent tonsillar infections. Participants will be randomly assigned to one of two groups: one where the wound bed is left bare after tonsillectomy, and another where the SupraTHEL 250 membrane is sutured onto the wound bed using resorbable interrupted sutures. The study is single-blinded and focuses on the early postoperative period. The membrane is being studied for its potential to promote faster and less painful healing. During the study, researchers will assess pain scores up to five days after surgery and evaluate quality of life using the Tonsillectomy Outcome Inventory-14 at five days postoperatively. Participants will be monitored closely during this period to track healing progress and any complications. The total duration of participation corresponds to the immediate postoperative recovery phase, emphasizing patient comfort and wound healing.

ST250 as a Therapeutic Option for Head & Neck Reconstruction