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Clinical Trials/NCT06543823
NCT06543823RecruitingNot Applicable

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

Alaa Emara1 site in 1 country80 target enrollmentStarted: April 30, 2025Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
80
Locations
1
Primary Endpoint
Pain Intensity (VAS)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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.

Exclusion Criteria

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

Arms & Interventions

Study group

Sham Comparator

The wound bed is left bare after the tonsillectomy procedure

Intervention: Comparator (Other)

Suprathel 250 group

Experimental

The SupraTHEL 250 membrane is sutured onto the wound bed after the tonsillectomy procedure

Intervention: Suprathel 250 (Device)

Outcomes

Primary Outcomes

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

  • Secondary Study Endpoints in Tonsillectomy Patients(Screening -- until 10 days Postoperative)

Investigators

Sponsor
Alaa Emara
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Alaa Emara

Associate Professor

Cairo University

Study Sites (1)

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