Use of ST250 to Reconstruct Lateral Tongue Defects

NCT ID: NCT06988449

Last Updated: 2025-05-23

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

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2025-03-30

Brief Summary

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To assess the use of SupraThel 250 for mucosal reconstruction in the Head \& Neck region. The membrane is applied to reconstruct lateral tongue defects . healing of the mucosa and regaining of normal tongue movement and speech are assessed postoperatively.

Detailed Description

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Lateral tongue defects are usually treated using radial fore-arm free grafts which require a prolonged hospital stay with higher morbidity rates. It also entails the need of multiple rehabilitation and remodeling porcdures of the transplnted flap to enable intelligible speech and tongue function.

Conditions

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Tongue Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Tongue defect covered with ST250

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* lateral tunge defects (postoncologic resection)

Exclusion Criteria

* radio / chemotherapy
* pregnant/ breastfeeding women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marienhospital Stuttgart

OTHER

Sponsor Role collaborator

Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Alaa Emara

A. Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dorothee Rickert, PhD

Role: PRINCIPAL_INVESTIGATOR

Marienhospital Stuttgart

Locations

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MarienHospital

Stuttgart, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

References

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Sarin V, Chatterjee A, Kakkar V, Juneja A. Evaluation of Tongue Functions After Free Flap Reconstruction. Indian J Otolaryngol Head Neck Surg. 2022 Oct;74(Suppl 2):2398-2403. doi: 10.1007/s12070-020-02177-1. Epub 2020 Oct 8.

Reference Type BACKGROUND
PMID: 36452650 (View on PubMed)

Related Links

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Other Identifiers

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ST250 for tongue defect

Identifier Type: -

Identifier Source: org_study_id

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