New method to close holes in the nasal septum
Nasal Septal Perforation Closure Using a 3-dimensional Fabricated Polycaprolactone Nasal Mesh
This study is testing a new type of nasal mesh to see if it can help close holes in the nasal septum for people who need surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 23 (estimated) |
| Ages | 18 Years to 58 Years |
| Sex | All |
| Sponsor | Helwan University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06439927 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a 3-dimensional fabricated nasal mesh in closing nasal septal perforations. The procedure involves placing the mesh between elevated mucoperichondrial flaps during repair surgery under general anesthesia. The position of the mesh will be confirmed using a nasal endoscope, and the status of the septal mucosa will be monitored monthly for three months following the surgery. This approach aims to improve surgical outcomes for patients with nasal septal perforations.
Who should consider this trial
Good fit: Ideal candidates for this study are patients scheduled for nasal septal perforation repair surgery.
Not a fit: Patients with known allergies to polycaprolactone or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this method could provide a more effective solution for patients suffering from nasal septal perforations.
How similar studies have performed: While there may be limited data on this specific approach, similar interventions using mesh materials have shown promise in other surgical applications.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing nasal septal perforation repair surgery. Exclusion Criteria: * Patients with known allergy to polycaprolactone. * Pregnancy or lactation.
Where this trial is running
Cairo
- Faculty of Medicine, Helwan University — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: Mohamed H Sebaey, master degree — Helwan University
- Study coordinator: Mohamed H Sebaey, Master degree
- Email: mohamed.h757@hotmail.com
- Phone: 01008306356
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.