Use of ST250 to Reconstruct Lateral Tongue Defects

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06988449

Enrollment

Registered

2025-05-23

Start date

2022-07-01

Completion date

2025-03-30

Last updated

2025-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tongue Neoplasms

Keywords

tongue defect, reconstruction, Polylactide membrane

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* lateral tunge defects (postoncologic resection)

Exclusion criteria

* radio / chemotherapy * pregnant/ breastfeeding women

Design outcomes

Primary

Measure	Time frame
Pain score	5 days

Countries

Germany

Outcome results