SUPRATHEL 250 as a Treatment for Oropharyngeal Wounds

NCT06543823 | Recruiting

• 1 other identifier: ST250 mucosal application
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Tonsillitis; Tonsillectomy; Tonsillitis Recurrent

Keywords

PLA membrane; Biodegradable membrane; Synthetic; Tonsillectomy; Suprathel

Outcome Measures

Primary Outcomes (1)

• Pain Intensity (VAS)

  Visual Analogue Scores (0-10; 0 lowest , 10 highest)

  postoperative day 0, 1, 2, 3, 4, 5, 7 and 10

Secondary Outcomes (1)

• Secondary Study Endpoints in Tonsillectomy Patients

  Screening -- until 10 days Postoperative

Study Arms (2)

Study group

SHAM COMPARATOR

The wound bed is left bare after the tonsillectomy procedure

Other: Comparator

Suprathel 250 group

EXPERIMENTAL

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

Device: Suprathel 250

Interventions

Suprathel 250 DEVICE

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

Suprathel 250 group

Comparator OTHER

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

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alaa Emara: lead

Study Sites (1)

Vinzenz von Paul Kliniken gGmbH Marienhospital Stuttgart

Stuttgart, Baden-Wurttemberg, 70199, Germany

RECRUITING

MeSH Terms

Conditions

Tonsillitis

Condition Hierarchy (Ancestors)

Pharyngitis; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Alaa Emara

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alaa Emara

CONTACT

+49711719500-182; alaa.emara@polymedics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: An interventional group with the application of the Suprathel 250 membrane and the control group with no membrane applied on the wound bed.

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 9, 2024
• Study Start: April 30, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)