Reconstruction Flaps for Nasal Surgical Wounds RCT

NCT ID: NCT04729231

Last Updated: 2025-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-31

Study Completion Date

2025-05-01

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.

Detailed Description

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Conditions

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Surgical Wound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Nasalis Sling Flap

Group Type ACTIVE_COMPARATOR

Nasalis Sling Flap

Intervention Type 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.

Lobed transposition flap

Group Type ACTIVE_COMPARATOR

Lobed Transposition Flap

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Murad Alam

Professor of Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Murad Alam, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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STU00211248

Identifier Type: -

Identifier Source: org_study_id

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