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Tympanic Membrane Perforation clinical trials

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NCT ID: NCT04761562 Recruiting - Clinical trials for Tympanic Membrane Perforation

Use of Autologous Plasma Rich in Platelets and Extracellular Vesicles in the Surgical Treatment of Chronic Middle Ear Infections

Start date: February 14, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This clinical study evaluates the efficacy of the autologous blood-derived product called platelet- and extracellular vesicle-rich plasma as a supplement to the surgical treatment of chronic tympanic membrane perforations. Half of the participants will be treated with standard surgical procedure called tympanoplasty and addition of platelet- and extracellular vesicle-rich plasma. Another half will be treated with only the standard tympanoplasty.

NCT ID: NCT04687995 Not yet recruiting - Clinical trials for Tympanic Membrane Perforation

Tragal Perichondrium Versus Pretragal Fascial (SMAS) Graft for Endoscopic Myringoplasty

Start date: January 2021
Phase: N/A
Study type: Interventional

1. Examine the treatment outcomes of the pretragal (SMAS) fascia as a new graft when used in endoscopic myringoplasty. 2. Compare the results when using the tragal pericondrium as a graft in endoscopic myringoplasty regarding donor site and success.

NCT ID: NCT04635228 Recruiting - Clinical trials for Tympanic Membrane Perforation

Biodesign® Otologic Repair Graft

Start date: September 29, 2021
Phase:
Study type: Observational

The post-market follow-up clinical trial of the Cook® Biodesign® Otologic Repair Graft will follow patients up to 3 months post-implantation to determine the percent of patients with complete closure of the tympanic membrane.

NCT ID: NCT04428463 Not yet recruiting - Clinical trials for Tympanic Membrane Perforation

Repair of Tympanic Membrane Perforation Using Tachosil Under Local Anesthesia

Start date: June 30, 2020
Phase: N/A
Study type: Interventional

Tympanic membrane perforations are common medical problem that encounters a lot of patients in all age groups. The gold standard for treatment of perforations is tympanic membrane closure procedure (tympanoplasty) which is done under general anesthesia. This procedure could be problematic for many patients who are not suitable for general anesthesia due to their medical status. It's also time consuming for the patient and for the medical system, since it takes a lot of time to reach the operation room and hospitalization for at least two days. The purpose in this study is to use Tachosil (Fibrinogen based patch) under local anesthesia to close tympanic membrane perforations. Tachosil is in use for hemostasis and for tissue repair after injury. Tachosil is bound to the tissue and form a waterproof membrane. In the setting of ENT clinic and under local anesthesia, the investigators will start the procedure with debridement of the tympanic perforation edges, then they will close the perforation using two pieces of Tachosil under and above the perforation in the right form (active side to the active side). If the results will be similar to tympanoplasty results, this method may be used for closure of tympanic perforation and save time and money for the patient and for the health system.

NCT ID: NCT04305184 Terminated - Clinical trials for Chronic Tympanic Membrane Perforation

A Study to Assess ASP0598 Otic Solution Following Topical Application in the Ear in Subjects With Chronic Tympanic Membrane Perforation (CTMP)

Start date: September 10, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The primary purpose of this study was to evaluate the safety and tolerability of ASP0598 Otic Solution. This study also evaluated the efficacy of ASP0598 otic solution.

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: NCT03904316 Withdrawn - Clinical trials for Tympanic Membrane Perforation

Use of Biodesign® Otologic Graft in Tympanoplasty

Start date: October 3, 2018
Phase: Phase 4
Study type: Interventional

This is a prospective, randomized trial to evaluate tympanoplasty outcomes using Biodesign SIS graft compared to autologous temporalis fascia, the most commonly used graft for repair of tympanic membrane.

NCT ID: NCT03837665 Recruiting - Clinical trials for Tympanic Membrane Perforation

Efficacy of Platelet Enriched Plasma in Preventing Surgery for Patients With Chronic Tympanic Membrane Perforation

Start date: May 2, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

By doing this study, researchers hope to find out if platelet rich plasma (PRP) can heal holes in the eardrum as an alternative to surgery.

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.