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Reconstruction Flaps for Nasal Surgical Wounds RCT

NCT04729231 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-05-06

No results posted yet for this study

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

Interventions

PROCEDURE

Nasalis Sling Flap

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.

PROCEDURE

Lobed Transposition Flap

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.

Sponsors & Collaborators

Principal Investigators

  • Murad Alam, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2025-05-01
Completion
2025-05-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04729231 on ClinicalTrials.gov