A Randomized Controlled Trial Comparing the Functional and Aesthetic Outcomes of Lobed Transposition Flaps vs. Nasalis Sling Flaps in Nasal Tip Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
The purpose of this study is to determine whether there is a significant difference in aesthetic and functional outcomes between nasalis sling flaps and lobed flaps of nasal tip wounds requiring reconstruction.
This is a randomized clinical trial. Approximately 32 participants who are undergoing nasal tip wound reconstruction surgery will be invited to participate and randomized to receive either the nasalis sling repair or the lobed flap repair. Patients will be asked to complete a few questionnaires including a VAS scale, the Surgical Outcomes scale, the NOSE instrument, and the Nasal Appearance and Function Evaluation Questionnaire (NAFEQ).
This study was a pilot study designed to determine the feasibility of these procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients >18 years
- •Defect located on the nasal tip, infratip, or supratip of the nose
- •Longest length of the wound should be no greater than 15mm
- •Participants must have the ability to understand and the willingness to sign a written informed consent prior to registration on study
排除标准
- •Active infection
- •Investigator judgement that patient is not suitable for randomization (preexisting scars or architecture that would make one repair option less likely to be successful)
- •Current cigarette smoking
- •Patients that have a disease or are taking medication that would severely impair wound healing in the opinion of the investigator
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: 6-16 weeks after the procedure
This visual analog scale (VAS) measures outcomes of functionality and appearance with values ranging on a continuum from 0 to 10, and higher scores representing a better outcome.
Nasal Obstruction Symptom Evaluation (NOSE) Instrument
时间窗: Baseline to 6-16 weeks
The Nasal Obstruction Symptom Evaluation (NOSE) Instrument is a questionnaire of nose functionality. This is a checklist of of problems related to the nose/nasal area with possible answers ranging from "not a problem" to a "severe problem".
Surgical Outcome Scale
时间窗: 6-16 weeks after the procedure
The Surgical Outcome Scale is a likert agreement scale on surgical outcomes with values ranging from 1 (agree) to 5 (disagree), and lower scores representing a better outcome.
Nasal Appearance and Function Evaluation Questionnaire (NAFEQ) Scale
时间窗: Baseline to 6-16 weeks
Nasal Appearance and Function Evaluation Questionnaire (NAFEQ) Scale is a likert scale on nasal appearance and function evaluations with values ranging from 1 (always; very poor; very dissatisfied) to 5 (never; excellent; very satisfied), and higher scores representing a better outcome.
次要结局
未报告次要终点
研究者
Murad Alam
Professor of Dermatology
Northwestern University