A Randomized Controlled Trial Comparing the Functional and Aesthetic Outcomes of Lobed Transposition Flaps vs. Nasalis Sling Flaps in Nasal Tip Reconstruction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Northwestern University
- Enrollment
- 32
- Locations
- 2
- Primary Endpoint
- Visual Analog Scale (VAS)
Study Overview
Brief Summary
The purpose of this study is to determine whether there is a significant difference in aesthetic and functional outcomes between nasalis sling flaps and lobed flaps of nasal tip wounds requiring reconstruction.
This is a randomized clinical trial. Approximately 32 participants who are undergoing nasal tip wound reconstruction surgery will be invited to participate and randomized to receive either the nasalis sling repair or the lobed flap repair. Patients will be asked to complete a few questionnaires including a VAS scale, the Surgical Outcomes scale, the NOSE instrument, and the Nasal Appearance and Function Evaluation Questionnaire (NAFEQ).
This study was a pilot study designed to determine the feasibility of these procedures.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •All patients >18 years
- •Defect located on the nasal tip, infratip, or supratip of the nose
- •Longest length of the wound should be no greater than 15mm
- •Participants must have the ability to understand and the willingness to sign a written informed consent prior to registration on study
Exclusion Criteria
- •Active infection
- •Investigator judgement that patient is not suitable for randomization (preexisting scars or architecture that would make one repair option less likely to be successful)
- •Current cigarette smoking
- •Patients that have a disease or are taking medication that would severely impair wound healing in the opinion of the investigator
Outcomes
Primary Outcomes
Visual Analog Scale (VAS)
Time Frame: 6-16 weeks after the procedure
This visual analog scale (VAS) measures outcomes of functionality and appearance with values ranging on a continuum from 0 to 10, and higher scores representing a better outcome.
Nasal Obstruction Symptom Evaluation (NOSE) Instrument
Time Frame: Baseline to 6-16 weeks
The Nasal Obstruction Symptom Evaluation (NOSE) Instrument is a questionnaire of nose functionality. This is a checklist of of problems related to the nose/nasal area with possible answers ranging from "not a problem" to a "severe problem".
Surgical Outcome Scale
Time Frame: 6-16 weeks after the procedure
The Surgical Outcome Scale is a likert agreement scale on surgical outcomes with values ranging from 1 (agree) to 5 (disagree), and lower scores representing a better outcome.
Nasal Appearance and Function Evaluation Questionnaire (NAFEQ) Scale
Time Frame: Baseline to 6-16 weeks
Nasal Appearance and Function Evaluation Questionnaire (NAFEQ) Scale is a likert scale on nasal appearance and function evaluations with values ranging from 1 (always; very poor; very dissatisfied) to 5 (never; excellent; very satisfied), and higher scores representing a better outcome.
Secondary Outcomes
No secondary outcomes reported
Investigators
Murad Alam
Professor of Dermatology
Northwestern University