NCT04729231

Reconstruction Flaps for Nasal Surgical Wounds RCT

A Randomized Controlled Trial Comparing the Functional and Aesthetic Outcomes of Lobed Transposition Flaps vs. Nasalis Sling Flaps in Nasal Tip Reconstruction

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2021-01-28
• Last updated: 2025-05-06

Locations

1 site across 1 country: United States