New Method to Close Nasal Septal Perforation

November 3, 2024 updated by: Mohamed Hossam Sebaey, Helwan University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Faculty of medicine, Helwan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients undergoing nasal septal perforation repair surgery.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Polycaprolactone nasal mesh
Device: Polycaprolactone nasal mesh
a 3-dimensional fabricated Polycaprolactone nasal mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
for a three months follow up period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
for a three months follow up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helwan University

Investigators

  • Principal Investigator: Mohamed H Sebaey, master degree, Helwan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

May 28, 2024

First Submitted That Met QC Criteria

May 28, 2024

First Posted (Actual)

June 3, 2024

Study Record Updates

Last Update Posted (Estimated)

November 5, 2024

Last Update Submitted That Met QC Criteria

November 3, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • self sponsored

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe