New Method to Close Nasal Septal Perforation
ConditionNasal Perforated Septum
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-58
SponsorHelwan University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing nasal septal perforation repair surgery.
Disqualifiers
Patients with known allergy to polycaprolactone.
Pregnancy or lactation.
Trial design
Design model
Single group
Treatments tested in this trial
Polycaprolactone nasal mesh
Devicea 3-dimensional fabricated Polycaprolactone nasal mesh
Treatment groups
23 Participants
are divided into 1 treatment groupGroup A: Polycaprolactone nasal meshExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mean Change in Post-operative healing of septal perforation
Endoscopic evaluation of nasal septal mucosa status will be classified as complete bilateral healing, complete unilateral healing, no healing, and perforation.
Time frame
for a three months follow up periodSecondary outcomes
1
Postoperative complications
The following complications will be evaluated on a present/absent basis:hematoma-infection-allergy
Time frame
for a three months follow up periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov