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临床试验/NCT04164550
NCT04164550已完成不适用

Postoperative Complications, Nasal Function, and Quality of Life Following Interpolated Flap Repair for Post-Mohs Surgical Defects of the Nose: a Multi-center Prospective Observational Cohort Study

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2018年4月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
170
试验地点
1
主要终点
Complication rate following Mohs micrographic surgery and flap inset

研究概览

简要总结

The primary purpose of this study is to address the limited knowledge regarding patient well- being and nasal function after interpolated flap repair of post-Mohs surgical defects on the nose. Improved understanding of the patient experience will allow providers to better counsel their patients pre-operatively and potentially identify patients who may benefit from additional interventions.

详细描述

This project is a multi-center prospective cohort study evaluating postoperative complication rates, quality of life outcomes, and nasal function after interpolated flap repair of post-Mohs surgical defects of the nose. Our primary outcome is the incidence of short-term complications(within 4 weeks of surgery) defined by the American College of Mohs Surgery as: death, bleeding requiring additional intervention, functional loss attributable to surgery, hospitalization for an operative complication, and surgical site infection. Secondary outcomes will include incidence of flap necrosis and evaluation of quality of life at 1, 4 and 16 weeks after repair. Quality of life will be investigated using the Skin Cancer Index (SCI)- a skin cancer specific quality of life instrument and the Nasal Appearance and Functional Evaluation Questionnaire (NAFEQ). Previous literature has demonstrated that Mohs surgery in the outpatient setting has a very low complication rate but this literature is generally limited to single-institution studies or studies examining smaller repairs. Furthermore, it has been proven that receiving a skin cancer diagnosis is stressful and patient satisfaction with skin cancer surgery is related to their appearance and scarring or changes in appearance can decrease quality of life. Our study serves to fill the current literature knowledge gaps by examining repair of large defects and looking at both complications and quality of life outcomes. Data collection will begin pre-operatively on patients 18 and older who require an interpolated flap repair of a post-Mohs surgical defect. These patients will then be followed and asked to complete SCI and NAFEQ surveys as well as complication questionnaires at prescribed intervals. All data will be stored via a secure RedCap database.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 18 years or older who are able to provide informed consent and may require interpolated flap repair of their post-Mohs surgical defect

排除标准

  • People who are not adults, not able to give informed consent, or who's wounds are not being repaired by a fellowship trained Mohs surgeon

结局指标

主要结局

Complication rate following Mohs micrographic surgery and flap inset

时间窗: 30 days

Short term (30 day) complications are defined by the American College of Mohs Surgery as death, bleeding requiring additional intervention, functional loss attributable to surgery, hospitalization for an operative outcome, and surgical site infection.

Complication rate following flap takedown

时间窗: 30 says

Short term (30 day) complications are defined by the American College of Mohs Surgery as death, bleeding requiring additional intervention, functional loss attributable to surgery, hospitalization for an operative outcome, and surgical site infection.

次要结局

  • Four weeks after flap takedown- Skin Cancer Index Score(4 weeks after flap takedown surgery)
  • Sixteen weeks after flap takedown- Skin Cancer Index Score(16 weeks after flap takedown surgery)
  • One week after Mohs- Nasal Appearance and Functional Evaluation Questionnaire (NAFEQ) Score(1 week after Mohs micrographic surgery)
  • One week after Mohs- Skin Cancer Index Score(1 week after Mohs micrographic surgery)
  • Four weeks after flap takedown- Nasal Appearance and Functional Evaluation Questionnaire (NAFEQ) Score(4 weeks after flap takedown surgery)
  • Sixteen weeks after flap takedown- Nasal Appearance and Functional Evaluation Questionnaire (NAFEQ) Score(16 weeks after flap takedown surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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