Post-operative Use of New Adhesive After Total Laryngectomy

Официальное название

Post-operative Use of the New Adhesive After Total Laryngectomy

Обзор

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).

Вмешательства

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

Первичные конечные точки

• Proportion of Participants Able to Use New Adhesive During Postoperative Period [Срок оценки: From enrollment to the end of treatment at 30 days.]

Вторичные конечные точки (12)

• Number of Skin Reactions or Pain/Discomfort Assessed by Investigator and Patient [Срок оценки: From enrollment to the end of treatment at 30 days.]
• Performance: Adhesive Adhesion Performance: Score on 5-Point Adhesion Rating Scale [Срок оценки: From enrollment to the end of treatment at 30 days.]
• Device Life Measured as Hours Adhesive Remains in Place [Срок оценки: From enrollment to the end of treatment at 30 days.]
• Performance: Adequacy of Adhesive Fit Around Stoma on a 5-Point Stoma Fit Scale [Срок оценки: From enrollment to the end of treatment at 30 days.]
• Performance: Ease of Adhesive Application and Removal on 5-Point Ease Scale [Срок оценки: From enrollment to the end of treatment at 30 days.]
• Performance: Ability to Observe Area Underneath Adhesive [Срок оценки: From enrollment to the end of treatment at 30 days.]
• Number of Participants for Whom Adhesive Was Successfully Applied Directly Over Sutures Without Complications [Срок оценки: From enrollment to the end of treatment at 30 days.]
• Number of Participants Able to Speak Using the Comfort Adhesive [Срок оценки: From enrollment to the end of treatment at 30 days.]
• Pulmonary rehabilitation: Average Hours of Heat and Moisture Exchanger Use per 24 Hours [Срок оценки: 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 [Срок оценки: From enrollment to the end of treatment at 30 days.]
• Use of Supplemental Oxygen During Postoperative Period [Срок оценки: From enrollment to the end of treatment at 30 days.]
• Patient-Reported Comfort Level: Score on 5-Point Comfort Scale [Срок оценки: From enrollment to the end of treatment at 30 days.]

Критерии участия

Критерии включения

• Patient undergoing total laryngectomy surgery
• 18 years or older

Критерии исключения

• Unable to give informed consent prior to TL surgery

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• Antoni van Leeuwenhoek, Netherlands Cancer Institute — Amsterdam

Идентификаторы

NCT: NCT07366281 · PL_Adhesive

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗