Post-operative Use of New Adhesive After Total Laryngectomy (NCT07366281) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Post-operative Use of New Adhesive After Total Laryngectomy
Netherlands25 participantsStarted 2026-08-17
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient undergoing total laryngectomy surgery
* 18 years or older
Exclusion Criteria:
* Unable to give informed consent prior to TL surgery
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a new adhesive for use right after total laryngectomy surgery — how important is the type of adhesive in the early recovery period, and is this something my care team thinks would be relevant to my situation?
2Since this trial is not yet recruiting, do you know when it might open, and would it make sense to plan around it or focus on what's available to me right now?
3The trial seems to be measuring whether patients can actually use this new adhesive during the post-operative period — what challenges do patients typically face with adhesives after laryngectomy, and how does that affect daily life in the short and long term?
4This study doesn't seem to have a specific drug or device phase attached to it, which suggests it's more about usability and practical outcomes — does that mean the main risks here are about wound healing and stoma care rather than an experimental treatment, and how would you weigh that for me?
5Are there already standard adhesives or stoma care products being used after laryngectomy that we should be considering now, and how would participating in this trial compare to what I'd receive as part of my normal post-surgical care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Participants Able to Use New Adhesive During Postoperative Period
Timeframe: From enrollment to the end of treatment at 30 days.