Reconstruction Flaps for Nasal Surgical Wounds RCT

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Controlled Trial Comparing the Functional and Aesthetic Outcomes of Lobed Transposition Flaps vs. Nasalis Sling Flaps in Nasal Tip Reconstruction

Conditions
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Surgical Wound

Intervention / Treatment
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* Procedure: Nasalis Sling Flap
* Procedure: Lobed Transposition Flap


Participation Criteria
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Eligibility Criteria
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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 Age <18 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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nasalis Sling Flap<br> | Procedure: Nasalis Sling Flap<br>* The nasalis sling flap involves alteration of the nasalis muscle to create a myocutaneous pedicle flap that will be used to fill in the wound.<br>|
| Active Comparator: Lobed transposition flap<br> | Procedure: Lobed Transposition Flap<br>* Lobed flap reconstruction involves the use of cutaneous tissue located adjacent to the nasal tip to fill in the wound. The flap will undergo a 90-degree arc to approximate the desired position.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) | 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. | 6-16 weeks after the procedure | 
| Surgical Outcome Scale | 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. | 6-16 weeks after the procedure | 
| Nasal Obstruction Symptom Evaluation (NOSE) Instrument | 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. | Baseline to 6-16 weeks | 
| Nasal Appearance and Function Evaluation Questionnaire (NAFEQ) Scale | 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. | Baseline to 6-16 weeks |