Post-operative Use of New Adhesive After Total Laryngectomy

Post-operative Use of the New Adhesive After Total Laryngectomy

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Laryngectomy
• Intervention / Treatment: Device: Provox Life Comfort Adhesive

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1066 CX
    • Antoni van Leeuwenhoek, Netherlands Cancer Institute
    • Contact: Michiel W.M. van den Brekel, Prof. Dr.; Phone Number: +31 512 25 50; Email: m.vd.brekel@nki.nl
    • Principal Investigator: Michiel W.M. van den Brekel, Prof. Dr.
    • Sub-Investigator: Klaske van Sluis
    • Sub-Investigator: Ahmed Alkashaf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient undergoing total laryngectomy surgery
• 18 years or older

Exclusion Criteria:

• Unable to give informed consent prior to TL surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exploratory post-operative use of Comfort Adhesive; Participants will start using a newly developed adhesive called Provox Life Comfort Adhesive in the immediate post-operative period following total laryngectomy.	Device: Provox Life Comfort Adhesive; The new Provox Life Comfort adhesive is a medical adhesive baseplate designed for tracheostoma care in laryngectomy patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Able to Use New Adhesive During Postoperative Period	Ability to use new adhesive continuously during the postoperative period, without discontinuation due to intolerance or complications related to the adhesive. Assessed through patient diary and investigator review.	From enrollment to the end of treatment at 30 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Skin Reactions or Pain/Discomfort Assessed by Investigator and Patient	Presence of skin reactions under or around the adhesive and pain/discomfort, assessed by investigator and patient. Skin condition evaluated using the Skin Integrity Severity Assessment Scale (0 = Normal, 1 = Mild, 2 = Moderate, 3 = Severe) and investigator assessment of erythema, vesicles, maceration, skin tears, crusting, and edema. Includes reported discomfort (VAS 0-10).	From enrollment to the end of treatment at 30 days.
Performance: Adhesive Adhesion Performance: Score on 5-Point Adhesion Rating Scale	Ability of adhesive to remain attached during intended wear period, assessed on a 5-point scale of Adhesion Rating Scale, that ranges from "Adhesion of Adhesive is very bad " to "Adhesion of Adhesive is very good".	From enrollment to the end of treatment at 30 days.
Device Life Measured as Hours Adhesive Remains in Place	Hours adhesive remains in place before replacement.	From enrollment to the end of treatment at 30 days.
Performance: Adequacy of Adhesive Fit Around Stoma on a 5-Point Stoma Fit Scale	Investigator and patients assessment of adhesive fit around stoma, assessed on a 5-point Stoma Fit scale ranging from "Adhesive does not fit at all" to "Adhesive fits very well".	From enrollment to the end of treatment at 30 days.
Performance: Ease of Adhesive Application and Removal on 5-Point Ease Scale	Patient and investigator rating/assessment of how easy adhesive is to apply and remove, assessed on a 5-point scale ranging from "Very difficult" to "Very easy".	From enrollment to the end of treatment at 30 days.
Performance: Ability to Observe Area Underneath Adhesive	Whether skin under adhesive can be inspected without removal.	From enrollment to the end of treatment at 30 days.
Number of Participants for Whom Adhesive Was Successfully Applied Directly Over Sutures Without Complications	Feasibility of applying adhesive over sutures without complications.	From enrollment to the end of treatment at 30 days.
Number of Participants Able to Speak Using the Comfort Adhesive	Ability to speak while the Comfort Adhesive is in place will be assessed by both the patient and the investigator using a binary response (Yes/No). A "Yes" response indicates the participant is able to speak with a voice prosthesis while using the Comfort Adhesive. Higher frequency of "Yes" responses reflects a better outcome.	From enrollment to the end of treatment at 30 days.
Pulmonary rehabilitation: Average Hours of Heat and Moisture Exchanger Use per 24 Hours	Hours of heat and moisture exchanger use per 24 hours.	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	Difficulty with sputum clearance while using the adhesive will be assessed by patient and investigator using a 4-point Mucus Trapping Scale ranging from "Mucus gets often trapped under the adhesive" to "Mucus never gets trapped under the adhesive".	From enrollment to the end of treatment at 30 days.
Use of Supplemental Oxygen During Postoperative Period	Need for supplemental oxygen will be assessed by investigator confirmation using a categorical response: Yes (used supplemental oxygen throughout); Yes, but weaned (used initially, then discontinued); No (did not use supplemental oxygen)	From enrollment to the end of treatment at 30 days.
Patient-Reported Comfort Level: Score on 5-Point Comfort Scale	Patient-reported comfort level using adhesive, assessed on a 5-point Comfort Scale ranging from "Very Uncomfortable" to "Very Comfortable."	From enrollment to the end of treatment at 30 days.

Collaborators and Investigators

• Sponsor: Atos Medical AB

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: December 19, 2025
• First Submitted That Met QC Criteria: January 16, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Adhesive baseplate; Tracheostoma care; Postoperative stoma management
• Other Study ID Numbers: PL_Adhesive

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No