Reconstruction Flaps for Nasal Surgical Wounds RCT

Northwestern University

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Conditions

Surgical Wound

Interventions

Nasalis Sling FlapPROCEDURE

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.

Lobed Transposition FlapPROCEDURE

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.

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Northwestern University

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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".

Time frame: 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.

Time frame: Baseline to 6-16 weeks

Data from ClinicalTrials.gov

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