New Method to Close Nasal Septal Perforation

NCT06439927 — Not applicable, Recruiting, 23 participants, Helwan University

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Nasal Septal Perforation Closure Using a 3-dimensional Fabricated Polycaprolactone Nasal Mesh

Registry	NCT06439927
Status	Recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	23 (Estimated)
Sponsor	Helwan University (Other)
Conditions	Nasal Perforated Septum
Interventions	Polycaprolactone nasal mesh (Device)
Dates	start 2024-08-01, primary completion 2025-09-01 (estimated), completion 2025-12-01 (estimated), first posted 2024-06-03, last updated 2024-11-05
Locations	1 site in Egypt

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Polycaprolactone nasal mesh	Experimental	Device: Polycaprolactone nasal mesh

Polycaprolactone nasal mesh (Device): a 3-dimensional fabricated Polycaprolactone nasal mesh

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 58 Years

Inclusion Criteria:

* Patients undergoing nasal septal perforation repair surgery.

Exclusion Criteria:

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

+Locations (1)

Facility	City	Country	Status
Faculty of Medicine, Helwan University	Cairo	Egypt	Recruiting

+Investigators

Mohamed H Sebaey, master degree, Principal investigator, Helwan University