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Post-operative Use of New Adhesive After Total Laryngectomy
Sponsor: Atos Medical AB
Summary
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).
Official title: Post-operative Use of the New Adhesive After Total Laryngectomy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
25
Start Date
2026-03-01
Completion Date
2027-04-01
Last Updated
2026-01-26
Healthy Volunteers
No
Conditions
Interventions
Provox Life Comfort Adhesive
The new Provox Life Comfort adhesive is a medical adhesive baseplate designed for tracheostoma care in laryngectomy patients.
Locations (1)
Antoni van Leeuwenhoek, Netherlands Cancer Institute
Amsterdam, Netherlands