Reconstruction Flaps for Nasal Surgical Wounds RCT

Surgical Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04729231
• Other study ID #: STU00211248
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2025
• Est. completion date: January 2025

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: Alejandra Onate, M.S.
• Phone: 3126956647
• Email: onate[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgical Wound

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS)	This visual analog scale (VAS) measures outcomes of functionality and appearance with values ranging on a continuum from 0 to 10, and higher scores representing a better outcome.	6-16 weeks after the procedure
Primary	Surgical Outcome Scale	The Surgical Outcome Scale is a likert agreement scale on surgical outcomes with values ranging from 1 (agree) to 5 (disagree), and lower scores representing a better outcome.	6-16 weeks after the procedure
Primary	Nasal Obstruction Symptom Evaluation (NOSE) Instrument	The Nasal Obstruction Symptom Evaluation (NOSE) Instrument is a questionnaire of nose functionality. This is a checklist of of problems related to the nose/nasal area with possible answers ranging from "not a problem" to a "severe problem".	Baseline to 6-16 weeks
Primary	Nasal Appearance and Function Evaluation Questionnaire (NAFEQ) Scale	Nasal Appearance and Function Evaluation Questionnaire (NAFEQ) Scale is a likert scale on nasal appearance and function evaluations with values ranging from 1 (always; very poor; very dissatisfied) to 5 (never; excellent; very satisfied), and higher scores representing a better outcome.	Baseline to 6-16 weeks