NCT07366281

Post-operative Use of New Adhesive After Total Laryngectomy

Post-operative Use of the New Adhesive After Total Laryngectomy

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Atos Medical AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Laryngectomy

Interventions

Type	Name	Description
DEVICE	Provox Life Comfort Adhesive	The new Provox Life Comfort adhesive is a medical adhesive baseplate designed for tracheostoma care in laryngectomy patients.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2026-01-26
• Last updated: 2026-01-26

Locations

1 site across 1 country: Netherlands