Post-operative Use of the New Adhesive After Total Laryngectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Proportion of Participants Able to Use New Adhesive During Postoperative Period
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing total laryngectomy surgery
- •18 years or older
排除标准
- •Unable to give informed consent prior to TL surgery
研究组 & 干预措施
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.
干预措施: Provox Life Comfort Adhesive (Device)
结局指标
主要结局
Proportion of Participants Able to Use New Adhesive During Postoperative Period
时间窗: From enrollment to the end of treatment at 30 days.
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.
次要结局
- 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.)
- Performance: Ability to Observe Area Underneath Adhesive(From enrollment to the end of treatment at 30 days.)
- Number of Participants for Whom Adhesive Was Successfully Applied Directly Over Sutures Without Complications(From enrollment to the end of treatment at 30 days.)
- Number of Participants Able to Speak Using the Comfort Adhesive(From enrollment to the end of treatment at 30 days.)
- Pulmonary rehabilitation: Average 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(From enrollment to the end of treatment at 30 days.)
- Use of Supplemental Oxygen During Postoperative Period(From enrollment to the end of treatment at 30 days.)
- Patient-Reported Comfort Level: Score on 5-Point Comfort Scale(From enrollment to the end of treatment at 30 days.)