NCT04164550

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2018

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 5, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 15, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

August 5, 2020

Status Verified

August 1, 2020

Enrollment Period

2.3 years

First QC Date

November 5, 2019

Last Update Submit

August 4, 2020

Conditions

Skin Cancer, Non-MelanomaSkin Cancer MelanomaMohs Micrographic Surgery

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Skin NeoplasmsMelanoma

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and Melanomas

Study Officials

  • Jeremy Etzkorn, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2019

First Posted

November 15, 2019

Study Start

April 18, 2018

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

August 5, 2020

Record last verified: 2020-08

Locations

US(1)