Tympanic Membrane Perforation

8

Review clinical trials related to Tympanic Membrane Perforation. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

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).

Participants needed: 35
Trial details
Age: 8-18Biological sex: AllType: InterventionalSponsor: Assiut UniversityUpdated: Oct 8, 2026
Eligibility criteria

Children aged 8-18 years [+5]

Cholesteatoma [+4]

Status: Not yet recruiting

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.

Participants needed: 50
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Assiut UniversityUpdated: Sep 22, 2026
Eligibility criteria

Age 18 years and older [+3]

Unsafe ear (e.g., presence of cholesteatoma, marginal perforation, or attic path... [+3]

Status: Not yet recruiting

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

Participants needed: 56
Trial details
Age: 18-60Biological sex: AllType: InterventionalSponsor: Muhammad Ali JavedUpdated: Sep 22, 2026
Eligibility criteria

Patients aged between 18 and 60 years [+4]

Age <18 years or >60 years [+9]

Status: Not yet recruiting

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.

Participants needed: 50
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Assiut UniversityUpdated: Sep 17, 2026
Eligibility criteria

Age 18 years or older [+7]

Active ear discharge at the time of surgery [+10]

Status: Not yet recruiting

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.

Participants needed: 500
Trial details
Age: 10+Biological sex: AllType: ObservationalSponsor: University Hospital, BrestUpdated: Dec 18, 2024Locations: 1
Eligibility criteria

Not listed

Status: Recruiting

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.

Participants needed: 44
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Central Adelaide Local Health Network IncorporatedUpdated: Nov 13, 2024Locations: 2
Eligibility criteria

Individuals who have otoscopic evidence of tympanic membrane perforation that is... [+8]

Operative ear is the better or only hearing ear [+7]

Status: Recruiting

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.

Participants needed: 45
Trial details
Age: 2-100Biological sex: AllType: InterventionalSponsor: Grace Medical, Inc.Updated: Oct 15, 2024Locations: 2
Eligibility criteria

Male or female patients over 2 years of age at enrollment [+2]

Active otorrhea or otitis media [+6]

Status: Not yet recruiting

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.

Participants needed: 20
Trial details
Age: 18-99Biological sex: AllType: InterventionalSponsor: HaEmek Medical Center, IsraelUpdated: Aug 13, 2024
Eligibility criteria

Chronic tympanic membrane perforation (>6 months). [+4]

Known ossicular chain dysfunction [+3]