Post-operative Use of New Adhesive After Total Laryngectomy

NCT07366281 | Not Yet Recruiting

• 1 other identifier: PL_Adhesive
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Laryngectomy

Keywords

Adhesive baseplate; Tracheostoma care; Postoperative stoma management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Number of Skin Reactions or Pain/Discomfort Assessed by Investigator and Patient

  From enrollment to the end of treatment at 30 days.

• Performance: Adhesive Adhesion Performance: Score on 5-Point Adhesion Rating Scale

  From enrollment to the end of treatment at 30 days.

• Device Life Measured as Hours Adhesive Remains in Place

  From enrollment to the end of treatment at 30 days.

• Performance: Adequacy of Adhesive Fit Around Stoma on a 5-Point Stoma Fit Scale

  From enrollment to the end of treatment at 30 days.

• Performance: Ease of Adhesive Application and Removal on 5-Point Ease Scale

  From enrollment to the end of treatment at 30 days.

Study Arms (1)

Exploratory post-operative use of Comfort Adhesive

EXPERIMENTAL

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

Interventions

Provox Life Comfort Adhesive DEVICE

The new Provox Life Comfort adhesive is a medical adhesive baseplate designed for tracheostoma care in laryngectomy patients.

Exploratory post-operative use of Comfort Adhesive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient undergoing total laryngectomy surgery
• years or older

You may not qualify if:

• Unable to give informed consent prior to TL surgery

Sponsors & Collaborators

• Atos Medical AB: lead

Study Sites (1)

Antoni van Leeuwenhoek, Netherlands Cancer Institute

Amsterdam, 1066 CX, Netherlands

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 26, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)