New Method to Close Nasal Septal Perforation

Not Applicable

Recruiting

• Conditions: Nasal Perforated Septum

• Registration Number: NCT06439927
• Lead Sponsor: Helwan University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-28
• Study First Submitted QC: 2024-05-28
• Study First Posted: 2024-06-03
• Study Start: 2024-08-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-03
• Last Update Posted: 2024-11-05
• Primary Completion: 2025-09
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Patients undergoing nasal septal perforation repair surgery.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Mean Change in Post-operative healing of septal perforation	for a three months follow up period	Endoscopic evaluation of nasal septal mucosa status will be classified as complete bilateral healing, complete unilateral healing, no healing, and perforation.

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	for a three months follow up period	The following complications will be evaluated on a present/absent basis:hematoma-infection-allergy

Trial Locations

Locations (1)

Faculty of Medicine, Helwan University; 🇪🇬 Cairo, Egypt