Post-operative Use of New Adhesive After Total Laryngectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Provox Life Comfort Adhesive.
- Who it may be relevant to
- Registry conditions: Laryngectomy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Post-operative Use of the New Adhesive After Total Laryngectomy
Overview
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).
Interventions
- Device Provox Life Comfort Adhesive
The new Provox Life Comfort adhesive is a medical adhesive baseplate designed for tracheostoma care in laryngectomy patients.
Primary outcome measures
- Proportion of Participants Able to Use New Adhesive During Postoperative Period [Time frame: From enrollment to the end of treatment at 30 days.]
Secondary outcome measures (12)
- Number of Skin Reactions or Pain/Discomfort Assessed by Investigator and Patient [Time frame: From enrollment to the end of treatment at 30 days.]
- Performance: Adhesive Adhesion Performance: Score on 5-Point Adhesion Rating Scale [Time frame: From enrollment to the end of treatment at 30 days.]
- Device Life Measured as Hours Adhesive Remains in Place [Time frame: From enrollment to the end of treatment at 30 days.]
- Performance: Adequacy of Adhesive Fit Around Stoma on a 5-Point Stoma Fit Scale [Time frame: From enrollment to the end of treatment at 30 days.]
- Performance: Ease of Adhesive Application and Removal on 5-Point Ease Scale [Time frame: From enrollment to the end of treatment at 30 days.]
- Performance: Ability to Observe Area Underneath Adhesive [Time frame: From enrollment to the end of treatment at 30 days.]
- Number of Participants for Whom Adhesive Was Successfully Applied Directly Over Sutures Without Complications [Time frame: From enrollment to the end of treatment at 30 days.]
- Number of Participants Able to Speak Using the Comfort Adhesive [Time frame: From enrollment to the end of treatment at 30 days.]
- Pulmonary rehabilitation: Average Hours of Heat and Moisture Exchanger Use per 24 Hours [Time frame: From enrollment to the end of treatment at 30 days.]
- Pulmonary rehabilitation: Interference With Sputum Clearance While Using Adhesive: Score on 4-Point Mucus Trapping Scale [Time frame: From enrollment to the end of treatment at 30 days.]
- Use of Supplemental Oxygen During Postoperative Period [Time frame: From enrollment to the end of treatment at 30 days.]
- Patient-Reported Comfort Level: Score on 5-Point Comfort Scale [Time frame: From enrollment to the end of treatment at 30 days.]
Eligibility criteria
Inclusion criteria
- Patient undergoing total laryngectomy surgery
- 18 years or older
Exclusion criteria
- Unable to give informed consent prior to TL surgery
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Netherlands · 1 center
- Antoni van Leeuwenhoek, Netherlands Cancer Institute — Amsterdam
Identifiers
NCT: NCT07366281 · PL_Adhesive