Post-operative use of a new adhesive after total laryngectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-arm feasibility study compares outcomes of a new Provox Life Comfort Adhesive used in the early post-operative period after total laryngectomy to historical controls. Participants will use the adhesive as part of standard post-surgical care, report comfort and skin status, and have routine clinical assessments for about 30 days. Researchers will review diaries and patient records to assess tolerance, skin condition, and overall practicality. There is no concurrent control group; historical data will serve as the comparator for safety and performance. The study is conducted at multiple centers in the Netherlands under lead sponsor Atos Medical AB.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient undergoing total laryngectomy surgery
* 18 years or older

Exclusion Criteria:

* Unable to give informed consent prior to TL surgery

Where it's running

• Maastricht University Medical Center
  Maastricht, Netherlands Recruiting
• Antoni van Leeuwenhoek, Netherlands Cancer Institute
  Amsterdam, Netherlands Not yet recruiting
• University Medical Center Groningen
  Groningen, Netherlands Not yet recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.