Clinical Research Directory

Outcomes of Cartilage Tympanoplasty in Children

This study evaluates the anatomical and hearing outcomes of cartilage tympanoplasty in pediatric patients with chronic tympanic membrane perforations. A perforation (hole) in the eardrum in children can lead to recurrent ear discharge, chronic middle-ear infections, and conductive hearing loss. Cartilage tympanoplasty is a surgical technique that uses autologous cartilage (the patient's own cartilage tissue) to reconstruct and seal the eardrum. Cartilage is known for its rigidity and resistance to retraction, which may offer advantages in children who frequently experience middle-ear pressure and ventilation issues. Children aged 8 to 18 years presenting with large, subtotal, or persistent dry central perforations will undergo cartilage tympanoplasty at Assiut University Hospitals. All participants will undergo standardized pre-surgical and post-surgical evaluations, including otological microscopic examinations and pure-tone audiometry tests. The main objectives are to evaluate the graft success rate (complete anatomical closure and stability of the eardrum) and to measure functional hearing restoration, specifically changes in air-conduction thresholds and the air-bone gap (ABG).

Audiometric Parameters in Conductive Hearing Loss and Middle Ear Disease

We study audiometric parameters including Transient Otoacoustic emissions, pure-tone audiometry for air- and bone-conduction, and spondaic speech recognition thresholds for air- and bone conduction in a pre- and postoperative situation in patients due for surgery for tympanic membrane perforations and otosclerosis. The hypotheses are that the precision of the preoperative assessment may be increased, and our knowledge about the effect on the inner ear by middle ear surgery may be increased.

Effectiveness of Silver Nitrate Cauterization vs Conservative Management in Tympanic Membrane Perforation Closure

The objective of this study is to evaluate the effectiveness of 50% silver nitrate chemical cauterization compared to conservative management (spontaneous healing) in closing small, dry tympanic membrane perforations. Patients presenting with a small (\<4 mm), dry, unilateral tympanic membrane perforation will be assigned to either receive weekly applications of 50% silver nitrate for up to 4 weeks or undergo observation for spontaneous healing. The primary outcome is to assess and compare the proportion of patients achieving complete tympanic membrane closure after 4 weeks of follow-up

Does Adding a Fascial Layer to the Cartilage in Tympanoplasty for Large Tympanic Membrane Perforation Affect the Overall Results?

Large tympanic membrane (eardrum) perforations present a surgical challenge and are historically associated with lower graft take rates compared to smaller perforations. While autologous cartilage provides durable structural support and resistance to retraction, surgeons differ on whether placing an additional layer of temporalis fascia over the cartilage graft improves anatomical closure and functional hearing. The primary purpose of this study is to determine whether adding a temporalis fascia layer to a conchal cartilage and perichondrium graft improves graft healing rates and audiological outcomes in patients undergoing tympanoplasty for large or subtotal perforations. Adult participants with safe chronic suppurative otitis media and large or subtotal tympanic membrane perforations are randomly assigned in a 1:1 ratio to one of two surgical arms: * Group A:Tympanoplasty using an autologous conchal cartilage graft with attached perichondrium alone. * Group B: Tympanoplasty using an autologous conchal cartilage and perichondrium graft reinforced with an additional outer layer of temporalis fascia placed between the cartilage and the tympanic membrane remnant. All participants undergo clinical otomicroscopy/otoendoscopy to assess graft take, healing, and complications, alongside pure-tone audiometry (evaluating air-bone gap and hearing thresholds) preoperatively and at 6 months postoperatively.

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. Anterior and subtotal eardrum perforations represent challenging surgical scenarios due to limited visualization, lack of anterior graft support, and higher risks of graft retraction, medialization, or residual perforation. The boomerang-shaped cartilage and perichondrium graft provides a sturdy cartilage framework along the anterior border to secure structural support, while maintaining a thin perichondrial layer over the functional vibratory area to facilitate acoustic transmission. All enrolled participants undergo endoscopic Type I tympanoplasty using this autologous grafting technique. Follow-up assessments are conducted at 1, 3, and 6 months after surgery to determine successful graft uptake, evaluate hearing improvement (via pure-tone audiometry and air-bone gap closure), and monitor for complications such as blunting, retraction, lateralization, or infection.

Insulin Intratympanic Application

The objective of the present study was to study the impact of insulin insitu-gel formulation on healing progress after surgical procedures for treatment of dry tympanic membrane perforation for at least three consecutive months. At the beginning, an insulin insitu-gel was prepared from three different polymers compatible with insulin physiochemically and reported to be vain on insulin efficacy or safety. Insulin insitu-gel was prepared using chitosan, polyvinyl alcohol, and Pluronic F127 with glycerol as a penetration enhancer. Selection of an optimized formulation through in situ gel characterization and in vitro drug release kinetics then the formulation was evaluated for healing efficacy on human volunteers in RCT. A randomized controlled clinical study was implemented for clinical evaluation of insitu-gel formulation activity in the Department of Otorhinolaryngology, Minia University Hospital, from March 2026 to May 2026. Perforation healing signs as a primary indicator was followed and reported in three follow-up visits (1 week, 1 month, and 2 months) in addition hearing score pre- and post-surgery as secondary outcomes. Results of a clinical study showed that the healing is significantly superior in the insulin group than in the control group

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 perichondrium or temporalis fascia) to close a hole in the eardrum (tympanic membrane perforation). The main questions this study aims to answer are: Does the eardrum hole close after surgery, and is the closure rate similar between Biodesign and autologous tissue grafts? Do participants have similar hearing improvement after surgery (measured by the air-bone gap, a common hearing test measure)? Is the operating time different between the graft types? Are there differences in complications or adverse reactions? Study hypothesis: Biodesign will have a similar eardrum closure rate compared with autologous tissue grafts, with similar hearing improvement and low complication rates, and may be associated with a shorter operating time. How the study will work: Investigators will review medical records of participants who had myringoplasty/tympanoplasty for eardrum perforation in the department between 2020 and 2024. Data already recorded as part of usual care will be collected, including: pre-surgery eardrum findings (size and location of the perforation) and hearing tests; operative details (technique and operating time); and follow-up at about 3 months, including an ear exam to confirm closure and check for adverse reactions, plus a hearing test. Participants will be excluded if they have other ear conditions (such as cholesteatoma, otosclerosis, or tympanosclerosis), if the eardrum was described as flaccid, or if follow-up or post-operative hearing data are missing.

A Prospective Comparative Study of Dry vs Wet Temporalis Fascia Graft in Tympanoplasty

This study was conducted to compare two methods of using temporalis fascia graft in tympanoplasty, namely wet temporalis fascia graft and dry temporalis fascia graft. Tympanoplasty is an ear surgery performed to repair a hole in the ear drum and to improve hearing in patients with chronic otitis media. Temporalis fascia is a thin layer of tissue taken from the area over the temple muscle and is commonly used as graft material for repair of the ear drum. The study included adult patients aged 18 to 60 years who had chronic otitis media with inactive mucosal disease, a large central perforation of the ear drum, and conductive hearing loss confirmed on pure-tone audiometry. Patients were assigned to one of two treatment groups. One group underwent tympanoplasty using a wet temporalis fascia graft, while the other group underwent tympanoplasty using a dry temporalis fascia graft. The main purpose of the study was to assess whether one graft preparation technique gave better surgical and hearing outcomes than the other. The outcomes were assessed three months after surgery. Hearing improvement was measured by comparing the air-bone gap before and after surgery on pure-tone audiometry. Graft success was assessed by otoscopic examination to determine whether the graft had healed properly, remained in correct position, and closed the ear drum perforation. Complete air-bone gap closure was also assessed as an additional hearing outcome.

Perf-Fix Study for Chronic Tympanic Membrane Repair

The purpose of the study is to assess the effectiveness of Perf-Fix as a gel patch to aid in the natural healing process to close chronic, \>25% tympanic membrane perforation.

Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations

This study is a double blinded, placebo-controlled phase II study evaluating the efficacy of FGF-2 for the treatment of chronic non-healing tympanic membrane perforations (TMP). The documentation of TM closure will be the main efficacy outcome measure. Pretreatment photographs will document the area of the TM perforation and allow measurement of surface areas of the TMP for comparison of pre- and post-treatment. The study will be divided into two phases, the Randomized Treatment phase (part A), and the Unblinded Crossover phase (part B). In part A of the study, subjects will be randomized 1:1 (using simple randomization) to receive FGF-2 or placebo treatment up to 3 treatments. Subjects that fail three study treatments will move on to part B of the study. Subjects who received placebo in part A and failed three placebo treatments will crossover to receive unblinded FGF-2 for up to 3 treatments. Subjects who received FGF-2 in part A and failed three experimental treatments will not have additional FGF-2 treatment, and will move on to study follow up.

Otological Study of Facial Cleft Patients Over 10 Years of Age (Excluding Isolated Cleft Lip) (EFEOF)

Studies published on the placement of transtympanic ventilatory tubes in children with cleft palate show heterogeneous results, highlighting the need for a new study with strong statistical power and long-term follow-up to clarify the real benefits of this intervention. Mirashrafi (2022) and Maina (2022), for example, emphasize the current uncertainties regarding the management of otitis media with effusion in children with cleft palate. Mirashrafi conducted a study on 40 children and found no significant difference between those with a complete cleft palate and those with an incomplete cleft palate in terms of middle ear status after the placement of transtympanic ventilatory tubes. Maina, in an ongoing review, identified a lack of consensus on the optimal management of chronic otitis media with effusion, with outcomes being varied and often of low methodological quality. The absence of convincing evidence justifies the need for further research to establish clear guidelines. The objective is to study the otological status of patients based on the presence or absence of ENT surgical management involving the placement of transtympanic ventilatory tubes.

Effect of Chitodex Gel in Tympanoplasty Surgery

The general purpose of this study is to compare Chitosan-dextran (Chitodex) gel versus current standard of care, Gelfoam, as a middle ear (ME) and external auditory canal (EAC) packing agent as part of tympanoplasty, ossiculoplasty and mastoidectomy procedures.

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. Tympanoseal is intended for use following removal or extrusion of indwelling tympanostomy tubes or traumatic injury of the tympanic membrane.

Trans Canal Tympanoplasty With Local Anesthesia Using Fat Graft and "TachoSil"

Eligible participants with chronic tympanic membrane perforation (\>6 month) will be given a detailed description and offered to participate in the study. the study investigates the efficacy of trans canal tympanoplasty with local anesthesia using fat pad and "Tachosil". Participants will be followed for 1 year after the procedure with otological examination and successive hearing evaluations.