Reconstruction Flaps for Nasal Surgical Wounds RCT

Not Applicable

Withdrawn

• Conditions: Surgical Wound
• Interventions: Procedure: Nasalis Sling Flap; Procedure: Lobed Transposition Flap

• Registration Number: NCT04729231
• Lead Sponsor: Northwestern University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-25
• Study First Submitted QC: 2021-01-25
• Study First Posted: 2021-01-28
• Study Start: 2025-01
• Status Verified: 2025-05
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nasalis Sling Flap	Nasalis Sling Flap	-
Lobed transposition flap	Lobed Transposition Flap	-

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	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	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	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	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.

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States