ST250 as a Therapeutic Option for Head & Neck Reconstruction

Phase 1

Recruiting

• Conditions: Tonsillitis
• Interventions: Other: Comparator; Device: SupraTHEL 250

• Registration Number: NCT06543823
• Lead Sponsor: Alaa Emara

Brief 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.

Study Timeline

• Study First Submitted: 2024-07-31
• Study First Submitted QC: 2024-08-05
• Study First Posted: 2024-08-09
• Status Verified: 2025-01
• Study Start: 2025-04-30
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-18
• Primary Completion: 2025-12
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• recurrent episodes of tonsillar infection

Exclusion Criteria

• children
• pregnant/ breastfeeding women
• patients undergoing chemo / radiotherapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Comparator	The wound bed is left bare after the tonsillectomy procedure
SupraTHEL 250 group	SupraTHEL 250	The SupraTHEL 250 membrane is suture ionto the wound bed after the tonsillectomy procedure

Primary Outcome Measures

Name	Time	Method
Pain scores	upto 5 days postoperatively	Visual Analogue Scores (0-10; 0 lowest , 10 highest)

Secondary Outcome Measures

Name	Time	Method
Quality of Life , Tonsillectomy Outcome Inventory - 14	5 days Postoperative	assessment of patients quality of life according to a set of questions

Trial Locations

Locations (1)

MarienHospital; 🇩🇪 Stuttgart, Baden-Wurttemberg, Germany