An interventional study of Provox Life Comfort Adhesive in Laryngectomy, sponsored by Atos Medical AB. Recruiting at 3 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Atos Medical AB · Not applicable, Interventional, and Treatment
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:
Exclusion Criteria:
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.
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.
Time frame: From enrollment to the end of treatment at 30 days.
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).
Time frame: 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".
Time frame: 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.
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
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".
Time frame: 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".
Time frame: 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.
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
Feasibility of applying adhesive 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
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.
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
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
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".
Time frame: 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)
Time frame: 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."
Time frame: From enrollment to the end of treatment at 30 days.
Plan to share: No
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Atos Medical AB