Post-operative Use of New Adhesive After Total Laryngectomy
Sponsor: Atos Medical AB • ClinicalTrials.gov ID: NCT07366281
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The goal of this clinical trial is to evaluate the feasibility, safety, and performance of the new adhesive when used in the immediate post-operative period after total laryngectomy. The main question it aims to answer is: \- Is the adhesive feasible and safe to use during the early post-operative phase? This is a single-arm feasibility study with historical controls, so there is no concurrent comparison group. Researchers will compare outcomes to historical data from standard adhesive use to assess improvements in tolerance and skin condition. Participants will: * Use the adhesive as part of their standard post-laryngectomy care. * Complete patient-reported outcome questionnaires (e.g., comfort, skin assessment, satisfaction). * Allow investigators to record observations in diaries and patient charts. * Participate in routine clinical assessments during hospitalization and at end of study (approximately 30 days post-surgery).
Interventions
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Provox Life Comfort Adhesive
(Device)
The new Provox Life Comfort adhesive is a medical adhesive baseplate designed for tracheostoma care in laryngectomy patients.
Eligibility criteria
Conditions
Locations
- Antoni van Leeuwenhoek, Netherlands Cancer Institute — Amsterdam, Netherlands
- University Medical Center Groningen — Groningen, Netherlands
- Maastricht University Medical Center — Maastricht, Netherlands
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Learn MoreOfficial Source
Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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