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NOT YET RECRUITING
NCT07366281
NA

Post-operative Use of New Adhesive After Total Laryngectomy

Sponsor: Atos Medical AB

View on ClinicalTrials.gov

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

DEVICE

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