Clinical trial NCT04164550: Interpolated Flap Study
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Cancer, Non-Melanoma
Skin Cancer Melanoma
Mohs Micrographic Surgery
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
name: Stanford University
name: University of Minnesota
name: University of Missouri-Columbia
name: University of Vermont
name: University of Nebraska
First posted: 2019-11-15
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients age 18 years or greater who are capable of providing informed consent and who may require an interpolated flap repair of their post-Mohs surgical defect will be recruited. If they consent to the study, they will be asked to complete the SCI and NAFEQ preoperatively. Patients who subsequently undergo interpolated flap repair will be followed and will complete subsequent SCI and NAFEQ surveys at one week from the date of the interpolated flap inset, 4 weeks after flap takedown, and 16 weeks after flap takedown. The target enrollment is 180 patients undergoing interpolated flap repair.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Complication rate following Mohs micrographic surgery and flap inset
timeFrame: 30 days
measure: Complication rate following flap takedown
timeFrame: 30 says
Secondary outcomes:
measure: One week after Mohs- Skin Cancer Index Score
timeFrame: 1 week after Mohs micrographic surgery
measure: Four weeks after flap takedown- Skin Cancer Index Score
timeFrame: 4 weeks after flap takedown surgery
measure: Sixteen weeks after flap takedown- Skin Cancer Index Score
timeFrame: 16 weeks after flap takedown surgery
measure: One week after Mohs- Nasal Appearance and Functional Evaluation Questionnaire (NAFEQ) Score
timeFrame: 1 week after Mohs micrographic surgery
measure: Four weeks after flap takedown- Nasal Appearance and Functional Evaluation Questionnaire (NAFEQ) Score
timeFrame: 4 weeks after flap takedown surgery
measure: Sixteen weeks after flap takedown- Nasal Appearance and Functional Evaluation Questionnaire (NAFEQ) Score
timeFrame: 16 weeks after flap takedown surgery
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Jeremy Etzkorn, MD
role: PRINCIPAL_INVESTIGATOR
References: