Z90.0
Conditions
Interventions
Group 1: Prospective, exploratory data collection investigating the acceptance and skin tolerability of biocompatible adhesive patches in individuals with aphonia or severe dysphonia, particularly aft
Sponsors
Altavo GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Aphonia or severe dysphonia, e.g. following total or partial laryngectomy (but not limited to this); > 6 months after primary tumor surgery or radiotherapy for Phase I; > 6 weeks after radiotherapy for Phase II; Use of a voice prosthesis or any other form of voice rehabilitation does not preclude inclusion; Written informed consent to participate in the evaluation; Sufficient proficiency in standard German (e.g. native speaker with completed language acquisition).
Exclusion criteria
Exclusion criteria: Current suspicion of tumor recurrence or medical complications; Hearing impairment relevant to speech production; Acute psychiatric disorder (e.g. major depression) or doubts about the ability to provide informed consent (e.g. dementia); Acute or chronic dermatological conditions in the orofacial region (excluding post-radiation skin changes) that may contraindicate the use of the adhesive patch or interfere with data evaluation; Poor general health condition that, in the investigator’s judgment, precludes study participation; Limited reading ability due to illiteracy or a native language other than German (relevant for information and documentation) Pronounced, non-modifiable facial hair (e.g. beard in the cheek area); Concurrent participation in another study; Active second primary malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acceptance and skin tolerability of the adhesive patches, assessed by DLQI and physician-rating. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of different wearing intervals, documentation of use in a wear diary, change in DLQI, and course of skin reactions. | — |
Countries
Germany
Contacts
Public ContactAndreas Müller
SRH Waldklinikum Gera GmbH
Outcome results
None listed