Clinical Trial

Post-operative Use of New Adhesive After Total Laryngectomy

Not Yet Recruiting
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).
Protocol Amendment History 2 changes
notable Primary completion pushed: 2027-04-01 -> 2027-08 2026-07-15
minor Completion pushed: 2027-04-01 -> 2027-08 2026-07-15
Trial Details
NCT Number NCT07366281
Lead Sponsor Atos Medical AB
Conditions Laryngectomy
Enrollment 25 participants
Start Date 2026-08-17
Primary Completion 2027-08 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2026-07-14