NCT06543823

Brief Summary

To assess the use of SupraThel 250 for mucosal reconstruction in the Head \& Neck region. The membrane will be applied after tonsillectomy procedures and compared to bare wounds' healing

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

April 30, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

May 18, 2025

Status Verified

January 1, 2025

Enrollment Period

7 months

First QC Date

July 31, 2024

Last Update Submit

May 16, 2025

Conditions

Tonsillitis

Keywords

PLA membraneBiodegradable membraneSyntheticTonsillectomy

Outcome Measures

Primary Outcomes (1)

  • Pain scores

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

    upto 5 days postoperatively

Secondary Outcomes (1)

  • Quality of Life , Tonsillectomy Outcome Inventory - 14

    5 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 suture ionto the wound bed after the tonsillectomy procedure

Device: SupraTHEL 250

Interventions

SupraTHEL 250DEVICE

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

SupraTHEL 250 group
ComparatorOTHER

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

Study group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • recurrent episodes of tonsillar infection

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MarienHospital

Stuttgart, Baden-Wurttemberg, 71638, Germany

RECRUITING

MeSH Terms

Conditions

Tonsillitis

Condition Hierarchy (Ancestors)

PharyngitisRespiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Alaa Emara

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alaa Emara

CONTACT

+49711719500-182alaa.emara@polymedics.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
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
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 31, 2024

First Posted

August 9, 2024

Study Start

April 30, 2025

Primary Completion

December 1, 2025

Study Completion

February 1, 2026

Last Updated

May 18, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)