Clinical trials: Eardrum Perforation
Otorrhea
Bacteriological Evaluation of Children With Otorrhea
After pneumococcal conjugate vaccine implementation, the number of acute otitis media (AOM) episodes has decreased, but AOM still remains among the most common diagnoses in childhood.
- Trial name
- NCT04807660
- Testing
- middle ear fluid sample for bacterial analysis (conventional microbiology analysis)
- Where
- France
- Volunteers
- 1,500 people
- Sponsor
- Association Clinique Thérapeutique Infantile du val de Marne
Perforated Eardrum
Inhalational Anesthesia vs TIVA in Endoscopic Tympanoplasty
This study aims to prospectively compare surgical field quality and intraoperative blood loss between general inhalational anesthesia to total intravenous anesthesia (TIVA) alone in subjects undergoing endoscopic ear surgery.
- Trial name
- TIVA (NCT05993039)
- Testing
- Isoflurane Inhalant Product, Sevoflurane inhalant product, Propofol injection
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Our Lady of the Lake Hospital
Tympanic Membrane Perforation
Tympanoseal Clinical Study
The purpose of this investigational study is to assess the ability of Tympanoseal (sodium/calcium alginate), an investigational device, to act as a scaffold during healing of the tympanic membrane.
- Trial name
- NCT05849844
- Testing
- Tympanoseal
- Where
- 2 sites in United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Grace Medical, Inc.
Middle Ear Effusion, Tympanic Membrane Perforation
PneuMum: Pneumococcal Vaccination of Australian Indigenous Mothers
PneuMum is a randomised controlled trial that aims to find out if pneumococcal vaccination for Australian Indigenous mothers, in the last few months of pregnancy or at delivery, can prevent ear disease in infants.
- Conditions
- Middle Ear Effusion, Tympanic Membrane Perforation, Acute Otitis Media, Pneumococcal Infections
- Trial name
- PneuMum (NCT00714064)
- Testing
- 23vPPV, dTpa (Pneumovax, Boostrix)
- Where
- Australia
- Volunteers
- 227 people, healthy volunteers welcome
- Sponsor
- Menzies School of Health Research
Tympanic Membrane Perforation, Chronic Otitis Media
Platelet-Rich Fibrin in Revision Cartilage Tympanoplasty
The aim of this study is to evaluate the success rate of revision surgery using a conchal cartilage graft supported with autologous platelet-rich fibrin (PRF), performed under local anesthesia, in patients who previously…
- Trial name
- NCT07893418
- Testing
- PRF-supported conchal cartilage tympanoplasty under local anesthesia
- Where
- Turkey (Türkiye)
- Volunteers
- 35 people
- Sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Otitis Media Chronic, Tympanic Membrane Perforation
Use of Autologous Plasma Rich in Platelets and Extracellular Vesicles in the Surgical Treatment of Chronic Middle Ear Infections
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.
- Trial name
- NCT04761562
- Testing
- Platelet- and extracellular vesicle-rich plasma, Control group
- Where
- Slovenia
- Volunteers
- 100 people
- Sponsor
- University Medical Centre Ljubljana
Tympanic Membrane Perforation, Eardrum Perforation
Biodesign® Otologic Repair Graft
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.
- Trial name
- NCT04635228
- Testing
- Biodesign Otologic Repair Graft
- Where
- 5 sites in United States, United Kingdom
- Volunteers
- 87 people
- Sponsor
- Cook Research Incorporated
Tympanic Membrane Perforation
Endoscopic Overlay Tympanoplasty for TM Perforation
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.
- Trial name
- NCT02331797
- Testing
- Endoscopic Technique, Microscopic Technique
- Where
- Thailand
- Volunteers
- 64 people
- Sponsor
- Prince of Songkla University
Chronic Otitis Media, Tympanic Membrane Perforation
Comparison of Postoperative Outcomes of Interlay vs Underlay Graft in Tympanoplasty
Chronic otitis media is a long-term ear infection that may cause a hole in the eardrum, leading to repeated ear discharge and hearing loss.
- Conditions
- Chronic Otitis Media, Tympanic Membrane Perforation, Conductive Hearing Loss
- Trial name
- NCT07149480
- Testing
- Underlay Tympanoplasty, Interlay Tympanoplasty
- Where
- Pakistan
- Volunteers
- 60 people
- Sponsor
- Shaikh Zayed Hospital, Lahore
Tympanic Membrane Perforation
Microscopic Versus Endoscopic Tympanoplasty
In this study, The investigatirs will compare surgical and anatomical outcomes of endoscopic and microscopic tympanoplasty type 1(myringoplasty) using tragal perichondrum and cartilage, and conduct a post-treatment survey…
- Trial name
- NCT06257602
- Testing
- Tragal graft tympanoplasty
- Volunteers
- 80 people
- Sponsor
- Assiut University
Tympanic Membrane Perforation
Repair of Tympanic Membrane Perforation Using Tachosil Under Local Anesthesia
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…
- Trial name
- NCT04428463
- Testing
- Tachosil, fascia and cartilage
- Volunteers
- 27 people
- Sponsor
- HaEmek Medical Center, Israel
Tympanic Membrane Perforation
Comparison Tympanoplasty With Membrane Amniotic and Autologous Fascia
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.
- Trial name
- NCT03569969
- Testing
- device: Tympanoplasty with Membrane Amniotic, Tympanoplasty With Autologous Fascia
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Mohammad Sadegh Bagheri Baghdasht
Tympanic Membrane Perforation, Chronic Otitis Media
Boomerang-Shaped Cartilage Graft in Endoscopic Tympanoplasty
This study evaluates the anatomical and functional outcomes of using a boomerang-shaped chondroperichondrial graft in endoscopic Type I tympanoplasty for repairing anterior or subtotal tympanic membrane perforations.
- Trial name
- NCT07823894
- Testing
- Endoscopic Type I Tympanoplasty with Boomerang-Shaped Chondroperichondrial Graft
- Volunteers
- 50 people
- Sponsor
- Assiut University
Tympanum; Perforation
General Anesthesia With or Without Local Ear Block in Middle Ear Surgeries
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…
- Trial name
- NCT03569046
- Testing
- local anaesthetic injection, Normal Saline Flush, 0.9% Injectable Solution, general anesthetic
- Where
- Egypt
- Volunteers
- 80 people
- Sponsor
- Abd-Elazeem Abd-Elhameed Elbakry
Otitis Media
Long-term Antibiotics for Treatment and Prevention of Otitis Media in Aborignal Children
This clinical trial was conducted in a population where tympanic membrane perforation occurs in 60% infants in the first year of life.
- Trial name
- COMIT1 (NCT00539149)
- Testing
- Amoxycillin
- Where
- Australia
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- Menzies School of Health Research
Tympanic Membrane Perforation
A Study on the Regenerative Treatment of Tympanic Membrane With NPC-18 and FBG-18
To assess the efficacy and safety of the regeneration treatment of tympanic membrane with NPC-18 and FBG-18.
- Trial name
- NCT02550314
- Testing
- fiblast,gelatin sponge,fibrin glue
- Volunteers
- 20 people
- Sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Tympanic Membrane Perforation, Tympanoplasty
Comparison of Results of Myringoplasty Using Biodesign - an Otologic Graft Made From Porcine Small Intestinal Submucosa, Temporalis Fascia, or Tragal Perichondrium - a Retrospective Cohort Analysis
The goal of this observational, retrospective study is to learn whether a ready-made graft patch (Biodesign, made from porcine small intestinal submucosa) works as well as a participant's own tissue graft (such as tragal…
- Conditions
- Tympanic Membrane Perforation, Tympanoplasty, Myringoplasty
- Trial name
- Biodesign (NCT07698171)
- Testing
- tympanoplasty using Biodesign, tympanoplasty using autologous tissue graft
- Where
- Israel
- Volunteers
- 60 people
- Sponsor
- Wolfson Medical Center
Tympanic Membrane Perforation
Fibrin Monomer Compared With Hemostatic Sponge in the Integrity of the Graft During Tympanoplasty
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…
- Trial name
- TISSUCOL (NCT02120651)
- Testing
- Fibrin monomer, Hemostatic sponge
- Where
- Mexico
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- CLOTILDE FUENTES OROZCO
Barotrauma;Ear, Tympanum; Perforation
Effectiveness of Sequential Eustachian Tube Maneuvers in Hyperbaric Oxygen Conditions
Middle ear barotrauma represents the predominant complication associated with hyperbaric oxygen therapy, manifesting symptoms ranging from otalgia to tympanic membrane perforation.
- Trial name
- NCT06408363
- Testing
- Maneuver group
- Where
- Brazil
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Hospital Felicio Rocho
Chronic Tympanic Membrane Perforation
In-office Repair of Chronic Tympanic Membrane Perforations
The goal of this clinical trial is to compare the application of fibroblast growth factor 2 (FGF2) with normal saline for the healing of chronic tympanic membrane (TM) perforations. This is an extension of a prior study.
- Trial name
- NCT06448039
- Testing
- Fibroblast Growth Factor 2, Saline control
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- D. Bradley Welling, MD, PhD