Reconstruction Flaps for Nasal Surgical Wounds RCT

NCT04729231 | Withdrawn

• 1 other identifier: STU00211248
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Wound

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Nasalis Sling Flap

ACTIVE COMPARATOR

Procedure: Nasalis Sling Flap

Lobed transposition flap

ACTIVE COMPARATOR

Procedure: Lobed Transposition Flap

Interventions

Nasalis Sling Flap PROCEDURE

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.

Nasalis Sling Flap

Lobed Transposition Flap PROCEDURE

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.

Lobed transposition flap

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: January 28, 2021
• Study Start: January 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-05

Locations

US (1)