ST250 as a Therapeutic Option for Head & Neck Reconstruction

NCT ID: NCT06543823

Last Updated: 2025-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-30

Study Completion Date

2026-02-28

Brief Summary

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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

Detailed Description

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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 opf 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

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Tonsillitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

An interventional group with the application of the SupraTHEL 250 membrane and the control group with no membrane applied on the wound bed
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Study group

The wound bed is left bare after the tonsillectomy procedure

Group Type SHAM_COMPARATOR

Comparator

Intervention Type OTHER

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

SupraTHEL 250 group

The SupraTHEL 250 membrane is suture ionto the wound bed after the tonsillectomy procedure

Group Type EXPERIMENTAL

SupraTHEL 250

Intervention Type DEVICE

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

Interventions

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SupraTHEL 250

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

Intervention Type DEVICE

Comparator

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* recurrent episodes of tonsillar infection

Exclusion Criteria

* children
* pregnant/ breastfeeding women
* patients undergoing chemo / radiotherapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alaa Emara

OTHER

Sponsor Role lead

Responsible Party

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Alaa Emara

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Alaa Emara

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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MarienHospital

Stuttgart, Baden-Wurttemberg, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Alaa Emara

Role: CONTACT

+49711719500-182

Facility Contacts

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Dorothee Rickert

Role: primary

+491795910797

Other Identifiers

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ST250 mucosal application

Identifier Type: -

Identifier Source: org_study_id

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