Tympanic Membrane PerforationNCT05282810
Cartilage Versus Temporalis Fascia Graft in Tympanoplasty for Recurrent Tympanic Membrane Perforation '' Comparative Study ''
An observational study of Tympanic Membrane Perforation, run by Assiut University.
Trial summary
Use of Cartilage Versus Temporalis Fascia as a Graft in Tympanoplasty for Recurrent Tympanic Membrane Perforation Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tympanic Membrane Perforation
- What is being tested?
- tympanoplasty
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Apr 2022to May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Patients will be randomly divided into Group 1, where only temporalis fascia alone will be used as a graft and Group 2, where cartilage will be used along with temporalis fascia graft. Patients will be followed up and examined at 2 and 6 month to assess 1. graft take up (healing) 2. pure tone audiometry( hearing )
Who may be able to join
- patients with safe chronic suppurative otitis media patient with recurrent perforation patirnt with coductive hearing loss
Who cannot join
- sensorineural hearing loss active infection compromised immune system
Trial locations and contacts
No sites are listed yet.
hamza el shafey ahmed, doctor contact
About this study
Official title: Cartilage Versus Temporalis Fascia Graft in Tympanoplasty for Recurrent Tympanic Membrane
Use of Cartilage Versus Temporalis Fascia as a Graft in Tympanoplasty for Recurrent Tympanic Membrane Perforation
Read the detailed description
The main aim of successful tympanoplasty is to create a well aerated closed cavity after total removal of the disease. Numerous types of grafting materials have been used for closure of the tympanic membrane including fascia, periosteum, perichondrium, cartilage, vein, skin, and fat tissue . Autografts are thought to be the most compatible grafting materials with the best surgical results in tympanoplasty Temporal muscle fascia is composed of irregularly arranged elastic fibers and fibrous connective tissue. For this reason postoperative dimensions of temporal muscle fascia are unpredictable.
Cartilage has a constant shape, firmer than fascia and also lack fibrous tissue, so that postoperative dimensions remains the same and beside this, it is also nourished by diffusion and show great adaptation with TM . These advantages make the cartilage graft more preferable by otologists recently.
the use of cartilage graft in many different ways such as perichondrium cartilage island technique, palisade technique or cartilage reinforcement technique
- Conditions
- Tympanic Membrane Perforation
- Being tested
- tympanoplasty
- Medical subject headings
- Tympanic Membrane Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tympanoplastyOther
use of cartilage versus tempotalis fascia in tympanoplasty for recuurent perforation
| Study group | Role | What they receive |
|---|---|---|
| cartilage tympanoplasty | use cartilage in tympanoplasty for recuurent perforation Receives: Other: tympanoplasty | |
| temporalis fascia graft in tympanoplasty | use temporalis fascia as a graft in tympanoplasty for recuurent perforation Receives: Other: tympanoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cartilage Versus Temporalis Fascia Graft in Tympanoplasty for Recurrent Tympanic Membrane Perforation '' Comparative Study ''
compare of improvment of hearing by using temporalis fascia versus cartilage tympanoplasty in recurrent perforation compare of graft take up by using temporalis fascia versus cartilage tympanoplasty in recurrent perforation
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study startApr 2022 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tympanic Membrane PerforationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroleen Mounir Tawfik, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282810
- Sponsor's protocol ID
- recurrent tympanoplasty
- Status last verified
- Mar 2022
- First submitted
- 8 Mar 2022
- Last updated
- 16 Mar 2022
- Results posted
- No
Publications
Jalali MM, Motasaddi M, Kouhi A, Dabiri S, Soleimani R. Comparison of cartilage with temporalis fascia tympanoplasty: A meta-analysis of comparative studies. Laryngoscope. 2017 Sep;127(9):2139-2148. doi: 10.1002/lary.26451. Epub 2016 Dec 9.
PubMed 27933630Shakya D, Nepal A. Long-term results of type I tympanoplasty with perichondrium reinforced cartilage palisade vs temporalis fascia for large perforations: A retrospective study. J Otol. 2021 Jan;16(1):12-17. doi: 10.1016/j.joto.2020.07.004. Epub 2020 Jul 29.
PubMed 33505444
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cartilage Versus Temporalis Fascia Graft in Tympanoplasty for Recurrent Tympanic Membrane
- ClinicalTrials.gov ID
- NCT05282810
- Acronym / sponsor ID
- recurrent tympanoplasty
- Conditions
- Tympanic Membrane Perforation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Use of Cartilage Versus Temporalis Fascia as a Graft in Tympanoplasty for Recurrent Tympanic Membrane Perforation
Detailed description
The main aim of successful tympanoplasty is to create a well aerated closed cavity after total removal of the disease. Numerous types of grafting materials have been used for closure of the tympanic membrane including fascia, periosteum, perichondrium, cartilage, vein, skin, and fat tissue . Autografts are thought to be the most compatible grafting materials with the best surgical results in tympanoplasty Temporal muscle fascia is composed of irregularly arranged elastic fibers and fibrous connective tissue. For this reason postoperative dimensions of temporal muscle fascia are unpredictable.
Cartilage has a constant shape, firmer than fascia and also lack fibrous tissue, so that postoperative dimensions remains the same and beside this, it is also nourished by diffusion and show great adaptation with TM . These advantages make the cartilage graft more preferable by otologists recently.
the use of cartilage graft in many different ways such as perichondrium cartilage island technique, palisade technique or cartilage reinforcement technique
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cartilage tympanoplasty | – | Other: tympanoplastyuse cartilage in tympanoplasty for recuurent perforation |
| temporalis fascia graft in tympanoplasty | – | Other: tympanoplastyuse temporalis fascia as a graft in tympanoplasty for recuurent perforation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients will be randomly divided into Group 1, where only temporalis fascia alone will be used as a graft and Group 2, where cartilage will be used along with temporalis fascia graft. Patients will be followed up and examined at 2 and 6 month to assess 1. graft take up (healing) 2. pure tone audiometry( hearing )
Key inclusion criteria (1 listed)
- patients with safe chronic suppurative otitis media patient with recurrent perforation patirnt with coductive hearing loss
Key exclusion criteria (1 listed)
- sensorineural hearing loss active infection compromised immune system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tympanoplastyuse of cartilage versus tempotalis fascia in tympanoplasty for recuurent perforation | Other | cartilage tympanoplasty, temporalis fascia graft in tympanoplasty |
Primary outcome
Cartilage Versus Temporalis Fascia Graft in Tympanoplasty for Recurrent Tympanic Membrane Perforation '' Comparative Study ''
Time frame: Baseline
compare of improvment of hearing by using temporalis fascia versus cartilage tympanoplasty in recurrent perforation compare of graft take up by using temporalis fascia versus cartilage tympanoplasty in recurrent perforation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Background: PubMed 27933630Jalali MM, Motasaddi M, Kouhi A, Dabiri S, Soleimani R. Comparison of cartilage with temporalis fascia tympanoplasty: A meta-analysis of comparative studies. Laryngoscope. 2017 Sep;127(9):2139-2148. doi: 10.1002/lary.26451. Epub 2016 Dec 9.
- Background: PubMed 33505444Shakya D, Nepal A. Long-term results of type I tympanoplasty with perichondrium reinforced cartilage palisade vs temporalis fascia for large perforations: A retrospective study. J Otol. 2021 Jan;16(1):12-17. doi: 10.1016/j.joto.2020.07.004. Epub 2020 Jul 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hamza el shafey ahmed, doctor contact
Questions about this trial
What is this clinical trial studying?
An observational study of Tympanic Membrane Perforation, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact caroleen mounir, researcher (01206045590, caroleenmounir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cartilage Versus Temporalis Fascia Graft in Tympanoplasty for Recurrent Tympanic Membrane Perforation '' Comparative Study '' (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05282810, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.