NCT06543823

ST250 as a Therapeutic Option for Head & Neck Reconstruction

The Use of Suprathel®250 as a Novel Therapeutical Option for Mucosal Healing in Head and Neck Surgery

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Alaa Emara · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To assess the use of SupraThel 250 for mucosal reconstruction in the Head \& Neck region. The membrane will be applied after tonsillectomy procedures and compared to bare wounds' healing

Detailed description

After tonsillectomy procedures, the wound is usually left bare to heal. This causes severe pain postoperatively and postoperative hemorrhage. SupraTHEL 250 is a synthetic biodegradable PLA membrane which is proven as a skin membrane in burn wounds with excellent result. We therefore hypothesize that the use opf SupraTHEL 250 after tonsillectomy procedures will allow for faster , less painful healing of the wound bed which allows for a better quality of life for the patients.

Conditions

• Tonsillitis

Interventions

Type	Name	Description
DEVICE	SupraTHEL 250	the membrane is placed onto the wound bed and fixed in place by resorbable interrupted sutures
OTHER	Comparator	no membrane is placed onto the wound bed , left bare to heal

Timeline

• Start date: 2025-04-30
• Primary completion: 2025-12-01
• Completion: 2026-02-01
• First posted: 2024-08-09
• Last updated: 2025-05-18

Locations

1 site across 1 country: Germany