Study Results
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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WITHDRAWN
NA
INTERVENTIONAL
2025-01-31
2025-05-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Nasalis Sling Flap
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.
Lobed transposition flap
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
ALL
Yes
Sponsors
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Northwestern University
OTHER
Responsible Party
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Murad Alam
Professor of Dermatology
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
Countries
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Other Identifiers
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STU00211248
Identifier Type: -
Identifier Source: org_study_id
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