Interpolated Flap Study

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

Patrocinadores

Patrocinador principal: University of Pennsylvania

Colaborador: Oregon Health and Science University
Stanford University
University of Minnesota
University of Missouri-Columbia
University of Vermont
University of Nebraska

Fuente University of Pennsylvania
Resumen breve

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.

Descripción detallada

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.

Estado general Completed
Fecha de inicio April 18, 2018
Fecha de Terminación August 1, 2020
Fecha de finalización primaria August 1, 2020
Tipo de estudio Observational
Resultado primario
Medida Periodo de tiempo
Complication rate following Mohs micrographic surgery and flap inset 30 days
Complication rate following flap takedown 30 says
Resultado secundario
Medida Periodo de tiempo
One week after Mohs- Skin Cancer Index Score 1 week after Mohs micrographic surgery
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
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
Inscripción 170
Condición
Elegibilidad

Método de muestreo: Non-Probability Sample

Criterios:

Inclusion Criteria:

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

Exclusion Criteria:

- 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

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Jeremy Etzkorn, MD Principal Investigator University of Pennsylvania
Ubicación
Instalaciones: University of Pennsylvania
Ubicacion Paises

United States

Fecha de verificación

August 2020

Fiesta responsable

Tipo: Sponsor

Tiene acceso ampliado No
Condición Examinar
Datos del paciente Undecided
Información de diseño del estudio

Modelo de observación: Cohort

Perspectiva de tiempo: Prospective

Fuente: ClinicalTrials.gov