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NCT07366281
Post-operative Use of New Adhesive After Total Laryngectomy
Conditions: Laryngectomy
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 25
Sponsor: Atos Medical AB
Location: Antoni van Leeuwenhoek, Netherlands Cancer Institute Amsterdam
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).
Eligibility Criteria
Inclusion Criteria:
* Patient undergoing total laryngectomy surgery
* 18 years or older
Exclusion Criteria:
* Unable to give informed consent prior to TL surgery
Source: ClinicalTrials.gov (NCT07366281). StuddyBuddy aggregates publicly available trial information.