New Method to Close Nasal Septal Perforation

Helwan University

Status: Enrolling

Conditions: Nasal Perforated Septum

Treatments: Device: Polycaprolactone nasal mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT06439927

self sponsored

Details and patient eligibility

About

The goal of this clinical trial is to investigate if a 3-dimensional fabricated nasal mesh works to close nasal septal perforations. Under general anesthesia, during nasal septal perforation repair surgery, the investigator will place the mesh between the elevated mucoperichondrial flaps opposite the site of the perforation and confirm its original position at both sides under nasal endoscope. Endoscopic examination for septal mucosa status will be done monthly for a three months follow up period.

Enrollment: 23 estimated patients

Sex: All

Ages: 18 to 58 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing nasal septal perforation repair surgery.

Exclusion criteria

• Patients with known allergy to polycaprolactone.
• Pregnancy or lactation.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Polycaprolactone nasal mesh

Experimental group

Treatment:

Device: Polycaprolactone nasal mesh