Reconstruction Flaps for Nasal Surgical Wounds RCT

Northwestern University

Status

Withdrawn

Conditions

Surgical Wound

Treatments

Procedure: Nasalis Sling Flap

Procedure: Lobed Transposition Flap

Study type

Interventional

Funder types

Other

Identifiers

NCT04729231

STU00211248

Details and patient eligibility

About

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.

Sex

All

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

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