An interventional study of Suprathel 250 and Comparator in Tonsillitis, Tonsillectomy and Tonsillitis Recurrent, sponsored by Alaa Emara. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by Alaa Emara · Not applicable, Interventional, and Treatment
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
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.
103 studies on the registry are indexed under Tonsillitis; 12 are open to participants now.
This study's planned enrollment of 80 is below the median of 100 across 87 interventional studies indexed under Tonsillitis.
Browse Tonsillitis studies →Alaa Emara is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The wound bed is left bare after the tonsillectomy procedure
Other: Comparator
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.
no membrane is placed onto the wound bed , left bare to heal
Pain Intensity (VAS)
Visual Analogue Scores (0-10; 0 lowest , 10 highest)
Time frame: postoperative day 0, 1, 2, 3, 4, 5, 7 and 10
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
Time frame: Screening -- until 10 days Postoperative
Plan to share: No
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