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Tympanic Membrane Perforation clinical trials

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NCT ID: NCT03416725 Not yet recruiting - Clinical trials for Tympanic Membrane Perforation

Evaluation of Prognostic Factors in Tympanoplasty

Start date: March 1, 2018
Phase: N/A
Study type: Observational

Tympanoplasty is the surgical operation performed for the reconstruction of the eardrum and/or the ossicles. Tympanoplasty is classified into five different types, originally described by Horst Ludwig Wullstein. 1,2 Type 1 involves repair of the tympanic membrane alone, when the middle ear is normal. A type 1 tympanoplasty is synonymous to myringoplasty, Type 2 involves repair of the tympanic membrane and middle ear in spite of slight defects in the middle ear ossicles, Type 3 when mallus and incus are absent graft place directly on stapes head., Type 4 describes a repair when the stapes foot plate is movable, but the crura are missing. The resulting middle ear will only consist of the Eustachian tube and hypotympanum, Type 5 is a repair involving a fixed stapes footplate. There are various prognostic factors reported in the literature that may influence the surgical success of tympanoplasty.

NCT ID: NCT03271970 Withdrawn - Clinical trials for Conductive Hearing Loss

The Anatomic Determinants of Perforation Induced Hearing Loss

Start date: April 2017
Phase: N/A
Study type: Observational

The purpose of this study is to identify factors that may contribute to conductive hearing loss. Conductive hearing loss is a type that is due to a problem with the outer or middle ear. Because of this, sound does not travel through the ear normally. Perforated tympanic membranes of study patients will be photographed during the patient's routine visit using a digital otoscope. These pictures will be used to analyze perforation size as an absolute value as well as a percentage of the tympanic membrane. Audiometric results and CT scans of temporal bone (reports and images) collected as standard of care will be evaluated. Images of CT scans will be imported into a medical imaging software for creation of anatomically realistic 3D models of the middle ear and mastoid air space. Structural analysis on each 3D model will be conducted and analyzed, the volume of middle ear and mastoid air spaces will be recorded, and data points will be correlated with perforation size and location to audiogram results.

NCT ID: NCT03028272 Withdrawn - Clinical trials for Tympanic Membrane Perforation

Hearing Results and Post Surgical Outcomes Using Amniotic Membrane Allograft vs. Fascia for Tympanoplasty

Start date: January 1, 2017
Phase: N/A
Study type: Interventional

The trial seeks to provide evidence that the Skye ActiveBarrier provides similar surgical and functional outcomes as fascia when used for tympanoplasties while offering benefits including reduced operative time, better patient satisfaction, and fewer 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.

NCT ID: NCT02000843 Completed - Clinical trials for Perforation of Eardrum.

Tympanoplasty Using Conchal Cavum Approach and Conchal Pericondrium

Start date: December 2013
Phase: N/A
Study type: Interventional

Tympanoplasty -- conchal cavum approach is a modification of Heermann endural approach to repair broken eardrums. The Heermann approach is a well recognized procedure, in common clinical practise for years. The new approach has been used in patients after informed consent was obtained from each patient.