SUPRATHEL 250 as a Treatment for Oropharyngeal Wounds

July 24, 2026 updated by: Alaa Emara

Der Einsatz Von SUPRATHEL 250 Als Neuartige Therapeutische Option in Oropharyngealen Defekten. // The Use of SUPRATHEL 250 as a Novel Therapeutic Option for Oropharyngeal Defects

To assess the use of Suprathel 250 for mucosal reconstruction in oropharyngeal defects. The membrane will be applied after tonsillectomy procedures and compared to bare wounds' healing

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 of 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 Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
    • Baden-Wurttemberg
      • Stuttgart, Baden-Wurttemberg, Germany, 70199
        • Recruiting
        • Vinzenz von Paul Kliniken gGmbH Marienhospital Stuttgart
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

  • Indication for tonsillectomy according to the applicable clinical guideline.
  • Male or female patients aged 18 years or older.
  • Ability to understand the study information and provide written informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Study group
The wound bed is left bare after the tonsillectomy procedure
Other: Comparator
no membrane is placed onto the wound bed , left bare to heal
Experimental: Suprathel 250 group
The SupraTHEL 250 membrane is sutured onto the wound bed after the tonsillectomy procedure
Device: Suprathel 250
The membrane is placed onto the wound bed and fixed in place by resorbable interrupted sutures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity (VAS)
Time Frame: postoperative day 0, 1, 2, 3, 4, 5, 7 and 10
Visual Analogue Scores (0-10; 0 lowest , 10 highest)
postoperative day 0, 1, 2, 3, 4, 5, 7 and 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Study Endpoints in Tonsillectomy Patients
Time Frame: Screening -- until 10 days Postoperative

CRP Description: CRP, venous blood. Time Frame: Day 4 Unit: mg/L

IL-6 Description: IL-6, venous blood. Time Frame: Day 4 Unit: pg/mL

Hemoglobin Description: Hb, venous blood. Time Frame: Day 4 Unit: g/dL

Speaking, Chewing, Swallowing Function Description: Problems reported, yes/no. Time Frame: Days 2-5, 7, 10 Unit: Participants

Wound Healing Rating Description: Investigator Wound Healing Rating Scale, range 1-5; 1 best, 5 worst.

Time Frame: Days 1-5 Unit: Score

Quality of Life Score Description: Tonsillectomy Outcome Inventory 14, 33 items, 0-5 each; range 0-165, higher worse.

Time Frame: Day 5 Unit: Score

Total Daily Analgesic Dose Description: Daily amount, medication diary. Time Frame: Days 1-5 Unit: mg

Participants With Complications or Adverse Events Description: Hemorrhage, allergy, infection, inflammation, reoperation, other AEs.

Time Frame: Screening to day 10 Unit: Participants
Screening -- until 10 days Postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alaa Emara

Investigators

  • Principal Investigator: Alaa Emara, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2025

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

July 31, 2024

First Submitted That Met QC Criteria

August 5, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

July 27, 2026

Last Update Submitted That Met QC Criteria

July 24, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ST250 mucosal application

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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