Skin Cancer, Non-Melanoma Clinical Trial
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
NCT number | NCT04164550 |
Other study ID # | 829285 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 18, 2018 |
Est. completion date | August 1, 2020 |
Verified date | August 2020 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 170 |
Est. completion date | August 1, 2020 |
Est. primary completion date | August 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania | Oregon Health and Science University, Stanford University, University of Minnesota, University of Missouri-Columbia, University of Nebraska, University of Vermont |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complication rate following Mohs micrographic surgery and flap inset | 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. | 30 days | |
Primary | Complication rate following flap takedown | 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. | 30 says | |
Secondary | One week after Mohs- Skin Cancer Index Score | 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. | 1 week after Mohs micrographic surgery | |
Secondary | Four weeks after flap takedown- Skin Cancer Index Score | 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 weeks after flap takedown surgery | |
Secondary | Sixteen weeks after flap takedown- Skin Cancer Index Score | 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. | 16 weeks after flap takedown surgery | |
Secondary | One week after Mohs- Nasal Appearance and Functional Evaluation Questionnaire (NAFEQ) Score | 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. | 1 week after Mohs micrographic surgery | |
Secondary | Four weeks after flap takedown- Nasal Appearance and Functional Evaluation Questionnaire (NAFEQ) Score | 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. | 4 weeks after flap takedown surgery | |
Secondary | Sixteen weeks after flap takedown- Nasal Appearance and Functional Evaluation Questionnaire (NAFEQ) Score | 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. | 16 weeks after flap takedown surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03040492 -
Vitamin D Receptor Polymorphisms and Non-Melanoma Skin Cancer Risk
|
||
Recruiting |
NCT05794035 -
Impact of Hypofractionated Radiotherapy Strategy After Surgery of Skin Carcinomas in Older Patients
|
N/A | |
Not yet recruiting |
NCT04805905 -
A Comparison of Skin Grafts Versus Local Flaps for Facial Skin Cancer From the Patient Perspective: A Feasibility Study
|
||
Completed |
NCT03457766 -
Presurgical Evaluation of Skin Cancers Using HIFU
|
N/A |