New Method to Close Nasal Septal Perforation
- Conditions
- Nasal Perforated Septum
- Interventions
- Device: Polycaprolactone nasal mesh
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 23
- Patients undergoing nasal septal perforation repair surgery.
- Patients with known allergy to polycaprolactone.
- Pregnancy or lactation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Polycaprolactone nasal mesh Polycaprolactone nasal mesh -
- 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