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NCT Number: NCT06439927

New Method to Close Nasal Septal Perforation

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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Key information

Conditions

Nasal Perforated Septum Nasal Septal Perforation Nose Diseases Otorhinolaryngologic Diseases Respiratory Tract Diseases Wounds and Injuries

Age range

18 year–58 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Helwan University

Cairo, Egypt

Location status: Recruiting

Location contact

Mohamed H Sebaey, master degree

CONTACT

[email protected]

01008306356

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing nasal septal perforation repair surgery.

Exclusion criteria

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

Treatment and study plan

Polycaprolactone nasal mesh

Device

a 3-dimensional fabricated Polycaprolactone nasal mesh

Primary outcomes

  1. Mean Change in Post-operative healing of septal perforation

    Time frame: 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

  1. Postoperative complications

    Time frame: for a three months follow up period

    The following complications will be evaluated on a present/absent basis:hematoma-infection-allergy

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed H Sebaey, Master degree

CONTACT

[email protected]

01008306356

Sponsors and collaborators

Lead sponsor

Helwan University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 3, 2024
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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