Nasal Perforated Septum
Conditions
Keywords
nasal septal perforation
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.
Interventions
DEVICEPolycaprolactone nasal mesh
a 3-dimensional fabricated Polycaprolactone nasal mesh
Sponsors
Helwan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 58 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing nasal septal perforation repair surgery.
Exclusion criteria
* Patients with known allergy to polycaprolactone. * Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complications | for a three months follow up period | The following complications will be evaluated on a present/absent basis:hematoma-infection-allergy |
Countries
Egypt
Contacts
Primary ContactMohamed H Sebaey, Master degree
Outcome results
None listed