TonsillitisNCT06543823
SUPRATHEL 250 as a Treatment for Oropharyngeal Wounds
A study testing Suprathel 250 and Comparator in people with Tonsillitis and Tonsillectomy, run by Alaa Emara at 1 site in Germany.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tonsillitis, Tonsillectomy, Tonsillitis Recurrent
- What is being tested?
- Suprathel 250 and Comparator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 30 Apr 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Vinzenz von Paul Kliniken gGmbH Marienhospital Stuttgart
Stuttgart, Baden-Wurttemberg, 70199
Dorothee Rickert, Prof. Dr., +491795910797, aalaa.emara@dentistry.cu.edu.eg
About this study
Official 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
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
Read the 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.
- Conditions
- Tonsillitis, Tonsillectomy, Tonsillitis Recurrent
- Being tested
- Suprathel 250, Comparator
- Keywords
- PLA membrane, Biodegradable membrane, Synthetic, Tonsillectomy, Suprathel
- Medical subject headings
- Tonsillitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suprathel 250Device
The membrane is placed onto the wound bed and fixed in place by resorbable interrupted sutures.
ComparatorOther
no membrane is placed onto the wound bed , left bare to heal
| Study group | Role | What they receive |
|---|---|---|
| Study group | Sham comparator | The wound bed is left bare after the tonsillectomy procedure Receives: Other: Comparator |
| Suprathel 250 group | Experimental | The SupraTHEL 250 membrane is sutured onto the wound bed after the tonsillectomy procedure Receives: Device: Suprathel 250 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity (VAS)
Visual Analogue Scores (0-10; 0 lowest , 10 highest)
Measured: postoperative day 0, 1, 2, 3, 4, 5, 7 and 10
Secondary outcomes (1)
Secondary Study Endpoints in Tonsillectomy Patients
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
Measured: Screening -- until 10 days Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start30 Apr 2025
- Primary completion30 Nov 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TonsillitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An interventional group with the application of the Suprathel 250 membrane and the control group with no membrane applied on the wound bed.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alaa Emara
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alaa Emara, Cairo University
- Investigators
- Alaa Emara, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543823
- Sponsor's protocol ID
- ST250 mucosal application
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2024
- Last updated
- 27 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06543823
- Acronym / sponsor ID
- ST250 mucosal application
- Conditions
- Tonsillitis, Tonsillectomy, Tonsillitis Recurrent
- Keywords
- PLA membrane, Biodegradable membrane, Synthetic, Tonsillectomy, Suprathel
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Alaa EmaraUniversity, hospital or other
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- An interventional group with the application of the Suprathel 250 membrane and the control group with no membrane applied on the wound bed.
| Arm | Type | Receives |
|---|---|---|
| Study group | Sham comparator | Other: ComparatorThe wound bed is left bare after the tonsillectomy procedure |
| Suprathel 250 group | Experimental | Device: Suprathel 250The SupraTHEL 250 membrane is sutured onto the wound bed after the tonsillectomy procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suprathel 250The membrane is placed onto the wound bed and fixed in place by resorbable interrupted sutures. | Device | Suprathel 250 group |
| Comparatorno membrane is placed onto the wound bed , left bare to heal | Other | Study group |
Primary outcome
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)
1 secondary outcome
Secondary Study Endpoints in Tonsillectomy Patients
Time frame: Screening -- until 10 days Postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alaa Emara principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suprathel 250 and Comparator in people with Tonsillitis and Tonsillectomy, run by Alaa Emara at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alaa Emara (+49711719500-182, alaa.emara@polymedics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (VAS) (time frame: postoperative day 0, 1, 2, 3, 4, 5, 7 and 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.