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Tympanic Membrane Perforation clinical trials

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NCT ID: NCT05605262 Completed - Clinical trials for Tympanic Membrane Perforation

Effects of 100% Medical Grade Manuka Honey on Tympanic Membrane Reconstruction Healing.

Start date: June 13, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Throughout history, honey has been recognized for its healing properties. The use of honey for its medicinal properties dates back to 2200 BCE. The purpose of this clinical trial is to learn about the healing effects of 100% medical grade Manuka honey in participants with Chronic Suppurative Otitis Media of the mucosal type. The main question it aims to answer is: Can 100% Manuka honey given at the time of Tympanoplasty improve the re-epithelialization (healing process) of the tympanic membrane compared to controls? Participants in the intervention group will receive a wound dressing of 100% medical grade Manuka honey after reconstructive surgery of the tympanic membrane. Researchers will compare the intervention group to the control group to see healing process.

NCT ID: NCT03922295 Completed - Clinical trials for Tympanic Membrane Perforation

Endoscopic Tympanoplasty: Single Versus Double Flap Technique

Start date: August 24, 2017
Phase: N/A
Study type: Interventional

Aim of this study is to compare results of double and single flap techniques for tympanoplasty in chronic suppurative otitis media patients. Inclusion criteria include total or subtotal tympanic membrane perforations with limited anterior remnant and should be dry for at least 3 months. Patients with persistent discharge, cholesteatoma, ossicular affection or those with recurrent perforations after previous myringoplasty were excluded. Also, patients with uncontrolled diabetes, chronic liver and kidney diseases and immuno-compromised patients are not included in this study. Patients are divided into two groups, endoscopic double flap group and endoscopic single flap group. Healing and hearing outcomes were evaluated 3 months postoperative. Also, post-operative pain scores and complications were assessed.

NCT ID: NCT03569969 Completed - Clinical trials for Tympanic Membrane Perforation

Comparison Tympanoplasty With Membrane Amniotic and Autologous Fascia

Start date: January 1, 2016
Phase: N/A
Study type: Interventional

The tympanic membrane separates the middle and the outer ear from each other and consists of three layers. The outer layer is covered with squamous epithelium, a thick basement membrane in the middle and an inner Mucosal layer. Rupture of the tympanic membrane is common cause of hearing loss. In spite of the ability to spontaneously healing of the tympanic membrane, chronic tear of the eardrum in the absence of its spontaneously healing indicates surgical management. These surgeries are performing using various materials including fascia, cartilage, fats, pericardium and paper patch. It has proven that using different materials results in outcome and postoperative complications. The criteria of the best graft material includes availability, preservability, manageability, and acceptance rate to the hosts. Human amniotic membrane is preservable. Also, there isn't significant immunologic reactions against such graft material. So, choosing the best graft for Tympanoplasty surgery decreases complications, hospitalizations after surgery, and costs, consequently. Up to now, limited studies have been conducted on the patients who were used amniotic membrane in the surgical reconstruction. There are different outcomes and complications which depend on the size of the rupture and the problems associated with the surgical conditions. Considering that it can reduce the surgical time and cost of surgery, and with its high success rate, it can even be used as a substitute for conventional methods. The aim of this study was to compare the result of surgical repair of the tympanic membrane using membrane amniotic and surgical Tympanoplasty with Autologous fascia. Here the investigators reported on 30 patients who underwent Typmanoplasty with amniotic membrane and Temporalis fascia grafting.

NCT ID: NCT03569046 Completed - Clinical trials for Tympanum; Perforation

General Anesthesia With or Without Local Ear Block in Middle Ear Surgeries

Start date: July 6, 2018
Phase: N/A
Study type: Interventional

Background: Proper selection of anesthetic technique is important in middle ear microsurgery. Controlled hypotension in ear surgery decreases blood loss with improved quality of the surgical field, however, it is associated with resistance to vasodilators and delayed recovery from anesthesia. The use of local anesthetic technique alone in middle ear surgery decreases bleeding and reduces postoperative pain, however, pain on injection, noise, and head‑neck position had been reported with the increased risk of patient injuries. This study aimed to compare the effects of local ear block combined with general anesthesia versus general anesthesia alone, regarding intraoperative hemodynamics, anesthetic consumption, recovery characteristics, postoperative pain, adverse effects and postoperative complications.

NCT ID: NCT02550314 Completed - Clinical trials for Tympanic Membrane Perforation

A Study on the Regenerative Treatment of Tympanic Membrane With NPC-18 and FBG-18

Start date: March 2015
Phase: Phase 3
Study type: Interventional

To assess the efficacy and safety of the regeneration treatment of tympanic membrane with NPC-18 and FBG-18.

NCT ID: NCT02331797 Completed - Clinical trials for Tympanic Membrane Perforation

Endoscopic Overlay Tympanoplasty for TM Perforation

Start date: December 2014
Phase: N/A
Study type: Interventional

Minimally invasive surgery is becoming more common in many surgical fields. The wide view of endoscope allows for minimally invasive transcanal approach instead of large postauricular opening. The investigators conduct this study to compared post operative pain score (by Visual Analogue Scales) between conventional microscope lateral placing tympanoplasty and endoscopic lateral placing tympanoplasty.

NCT ID: NCT02307916 Completed - Clinical trials for Tympanic Membrane Perforation

Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations

Start date: October 2016
Phase: Phase 2
Study type: Interventional

A Phase II randomized trial will be initiated to evaluate closure of the perforated tympanic membrane as the primary measureable outcome. The goal is to determine the safety and efficacy of Fibroblast Growth Factor-2 (FGF-2) in the closure of chronic tympanic membrane perforations (TMP). If FGF-2 is topically applied for the treatment of chronic TMP in humans, it is hypothesized it will be safe, tolerable and effective for use as treatment for tympanic membrane perforation. A total of 60 subjects will be recruited.

NCT ID: NCT02296944 Completed - Clinical trials for Tympanic Membrane Perforation

Anatomical and Functional Results of Surgery of the Tympanic Membrane Perforation of the Child

PERFOPED
Start date: January 6, 2015
Phase: N/A
Study type: Observational

This study is a retrospective cohort of patients minors during the operation of cartilage tympanoplasty for tympanic membrane perforation

NCT ID: NCT02120651 Completed - Clinical trials for Tympanic Membrane Perforation

Fibrin Monomer Compared With Hemostatic Sponge in the Integrity of the Graft During Tympanoplasty

TISSUCOL
Start date: January 2012
Phase: Phase 3
Study type: Interventional

The diagnosis of tympanic perforation reaches a high number of records in otorhinolaryngology services worldwide. Most of the tympanoplasties are performed in patients whose cause of perforation and hearing loss was chronic otitis media; this entity affects the population between 0.5 to 30% , the statistics mention more than 20 million people with this disease in the world. Since the introduction of tympanoplasty in the second half of the nineteenth century there have been numerous publications nationally and internationally about various experiences and new techniques. Including the use of fibrin monomer . This procedure is usually performed with the use of hemostatic sponge and recently with fibrin monomer, both materials are part of the basic input and surgical hemostatic agents. In this hospital are performed on average 110 tympanoplasty per year which has a percentage of non- integrity of the graft in the case of microscopic tympanoplasties using hemostatic sponge of 16% which is similar to the index of lack of integrity of the graft in microscopic tympanoplasties reported worldwide (18%), with the recent addition to the service of fibrin monomer, was necessary to evaluate if this material contributes to the integrity of the graft in microscopic tympanoplasty, as it has been reported in previous studies, so if there is found more integrity with this material, it can be recommended for routine use, improving the final prognosis of the patients.

NCT ID: NCT02019888 Completed - Clinical trials for Hearing Loss, Sensorineural

Wide Frequency Band Test of Hearing in Veterans

CWTBAFV
Start date: December 1, 2014
Phase:
Study type: Observational

The accurate assessment of auditory status is critical for planning treatment for Veterans with hearing loss to include medical and audiological management. Current physiologic tests of auditory function in the standard clinical audiological test battery for Veterans have limited sensitivity in detecting some middle-ear disorders, and do not include a direct test of cochlear function. Recent studies have shown promise for new wide-bandwidth (WB) tests of absorbance for improved sensitivity in the assessment of middle-ear function including acoustic reflex testing. The addition of WB tests of cochlear function included in the WB test battery provides an opportunity to improve audiological diagnosis of a range of hearing disorders in Veterans. The automation provided by the WB test battery could provide additional benefits in reducing the duration of the evaluation, leaving more time for evaluation of test findings and counseling. Results from this study may lead to the improvement of audiological care for Veterans with hearing loss.