Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06543823

SUPRATHEL 250 as a Treatment for Oropharyngeal Wounds

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Tonsillitis Infections Otorhinolaryngologic Diseases Pharyngeal Diseases Pharyngitis Respiratory Tract Diseases Respiratory Tract Infections Stomatognathic Diseases Tonsillectomy Tonsillitis Recurrent

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vinzenz von Paul Kliniken gGmbH Marienhospital Stuttgart

Stuttgart, Baden-Wurttemberg, 70199, Germany

Location status: Recruiting

Location contact

Dorothee Rickert, Prof. Dr.

CONTACT

[email protected]

+491795910797

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Suprathel 250

Device

The membrane is placed onto the wound bed and fixed in place by resorbable interrupted sutures.

Comparator

Other

no membrane is placed onto the wound bed , left bare to heal

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Alaa Emara

CONTACT

[email protected]

+49711719500-182

Sponsors and collaborators

Lead sponsor

Alaa Emara

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 9, 2024
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.