Post-operative Use of New Adhesive After Total Laryngectomy

Atos Medical

Status: Begins enrollment this month

Conditions: Laryngectomy

Treatments: Device: Provox Life Comfort Adhesive

Study type: Interventional

Funder types: Industry

Identifiers

NCT07366281

PL_Adhesive

Details and patient eligibility

About

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).

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient undergoing total laryngectomy surgery
• 18 years or older

Exclusion criteria

• Unable to give informed consent prior to TL surgery

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Exploratory post-operative use of Comfort Adhesive

Experimental group

Description:

Participants will start using a newly developed adhesive called Provox Life Comfort Adhesive in the immediate post-operative period following total laryngectomy.

Treatment:

Device: Provox Life Comfort Adhesive