Reconstruction Flaps for Nasal Surgical Wounds

Overseen By Alejandra Onate, M.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Active infection, Age <18, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

Trial Summary

What is the purpose of this trial?

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.

Research Team

Murad Alam, MD

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for adults over 18 with a nasal tip wound no larger than 15mm, who can understand and sign consent. It's not for those under 18, current smokers, people with infections or conditions that affect healing, or if their nose shape makes certain repairs less likely to work.

Inclusion Criteria

Participants must have the ability to understand and the willingness to sign a written informed consent prior to registration on study

I am older than 18 years.

My nasal defect is on the tip or close to the tip of my nose.

Exclusion Criteria

I currently have an infection.

I am under 18 years old.

My doctor thinks certain treatments won't work well for me due to my body's condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo nasal tip wound reconstruction surgery using either nasalis sling flaps or lobed flaps

1 day

1 visit (in-person)

Follow-up

Participants are monitored for functional and aesthetic outcomes using various questionnaires

6-16 weeks

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• Lobed Transposition Flap
• Nasalis Sling Flap

Trial Overview The study compares two types of nasal reconstruction techniques: nasalis sling flaps versus lobed transposition flaps. Participants will be randomly assigned to one of the methods and will complete questionnaires to assess aesthetic and functional outcomes.

Participant Groups

Group I: Nasalis Sling Flap Active Control 1 Intervention

Group II: Lobed transposition flap Active Control 1 Intervention

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+