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Completed

NCT Number: NCT04164550

Interpolated Flap Study

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.

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Key information

Conditions

Skin Cancer, Non-Melanoma Melanoma Mohs Micrographic Surgery Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Cancer Melanoma Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Complication rate following Mohs micrographic surgery and flap inset

    Time frame: 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.

  2. Complication rate following flap takedown

    Time frame: 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.

Secondary outcomes

  1. One week after Mohs- Skin Cancer Index Score

    Time frame: 1 week after Mohs micrographic surgery

    Skin Cancer Index is 15-item, disease specific, validated, quality of life instrument with three sub-scales, Emotion, Social, Appearance. A 5-point response format is used for each question where 1 equals "very much" and 5 equals "not at all". Standardized Scores Range from 0-100 with higher scores indicating higher quality of life. Standardized scores are obtained by summing the individual scores and dividing them by the number of items in each sub-scale.

  2. Four weeks after flap takedown- Skin Cancer Index Score

    Time frame: 4 weeks after flap takedown surgery

    Skin Cancer Index is 15-item, disease specific, validated, quality of life instrument with three sub-scales, Emotion, Social, Appearance. A 5-point response format is used for each question where 1 equals "very much" and 5 equals "not at all". Standardized Scores Range from 0-100 with higher scores indicating higher quality of life. Standardized scores are obtained by summing the individual scores and dividing them by the number of items in each sub-scale.

  3. Sixteen weeks after flap takedown- Skin Cancer Index Score

    Time frame: 16 weeks after flap takedown surgery

    Skin Cancer Index is 15-item, disease specific, validated, quality of life instrument with three sub-scales, Emotion, Social, Appearance. A 5-point response format is used for each question where 1 equals "very much" and 5 equals "not at all". Standardized Scores Range from 0-100 with higher scores indicating higher quality of life. Standardized scores are obtained by summing the individual scores and dividing them by the number of items in each sub-scale.

  4. One week after Mohs- Nasal Appearance and Functional Evaluation Questionnaire (NAFEQ) Score

    Time frame: 1 week after Mohs micrographic surgery

    The NAFEQ is a 14-item, validated quality of life instrument with two sections. The first seven items regard nasal function and airway passage, while the following seven questions assess satisfaction with nasal appearance. Responses are rated on a 5-point Likert scale where 1 equals "always" or "very dissatisfied", depending on the question, and 5 equals "never" or "very satisfied". Potential scores range from 7-35 with higher scores indicating greater satisfaction with overall nasal functioning and appearance.

  5. Four weeks after flap takedown- Nasal Appearance and Functional Evaluation Questionnaire (NAFEQ) Score

    Time frame: 4 weeks after flap takedown surgery

    The NAFEQ is a 14-item, validated quality of life instrument with two sections. The first seven items regard nasal function and airway passage, while the following seven questions assess satisfaction with nasal appearance. Responses are rated on a 5-point Likert scale where 1 equals "always" or "very dissatisfied", depending on the question, and 5 equals "never" or "very satisfied". Potential scores range from 7-35 with higher scores indicating greater satisfaction with overall nasal functioning and appearance.

  6. Sixteen weeks after flap takedown- Nasal Appearance and Functional Evaluation Questionnaire (NAFEQ) Score

    Time frame: 16 weeks after flap takedown surgery

    The NAFEQ is a 14-item, validated quality of life instrument with two sections. The first seven items regard nasal function and airway passage, while the following seven questions assess satisfaction with nasal appearance. Responses are rated on a 5-point Likert scale where 1 equals "always" or "very dissatisfied", depending on the question, and 5 equals "never" or "very satisfied". Potential scores range from 7-35 with higher scores indicating greater satisfaction with overall nasal functioning and appearance.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 15, 2019
Registry last updated
Aug 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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