Hearing Loss,ConductivePTANCT03817242
Half-thickness Tragal Cartilage Graft vs Temporalis Fascia Graft Tympanoplasty Type I
A study testing Tympanoplasty using tragal cartilage graft and Tympanoplasty using temporalis fascia graft in people with Hearing Loss,Conductive, run by Lady Reading Hospital, Pakistan at 1 site in Pakistan.
Trial summary
The rationale of this study is to find out the surgical outcome and success rates of tragal cartilage and temporalis fascia, subsequently to develop guide line in light of the results of this study for our department as our institute is going to follow one patient in one bed policy in future. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Hearing Loss,Conductive
- What is being tested?
- Tympanoplasty using tragal cartilage graft and Tympanoplasty using temporalis fascia graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2017to 31 Dec 2017
- Phase
- Interventional
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All patients of both genders in the age range 16 - 60 years.
- Inactive mucosal COM remained dry for at least one month.
- Conductive hearing loss with minimum air-bone gap (ABG) of 10 Decibel (dB).
- Middle ear is free of disease.
Who cannot join
- Attic and / or posterior retraction pocket with cholesteatoma.
- Ossicular chain dysfunction and associated otogenic complication.
- Active mucosal COM.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Half-thickness Tragal Cartilage Graft to Temporalis Fascia Graft
The rationale of this study is to find out the surgical outcome and success rates of tragal cartilage and temporalis fascia, subsequently to develop guide line in light of the results of this study for our department as our institute is going to follow one patient in one bed policy in future. The purpose of this study is to compare the graft success rate of cartilage versus temporalis fascia in tympanoplasty type I in our institute, as no such study has been conducted in our province before.
Read the detailed description
Tympanic membrane is forming lateral wall of the middle ear cleft which separates middle ear from the external auditory canal. It is made of three layers except in the upper part (Pars Flaccida). The outer layer of TM (Tympanic Membrane) is made of epithelium; middle layer is fibrous tissue, while inner layer is mucosal lining. The thickness of TM measures 0.1 mm, having diameter of 7-10 mm, weighing approximately 14 mg. The function of TM is to assist in hearing and protection of middle ear from infection. Perforation in tympanic membrane is the loss in continuity of TM layers. The causes of TM perforation may be trauma like blast, accident and firearm or infection of the middle ear like acute or chronic suppurative otitis media. It can also be iatrogenic as in case of placement of grommet for glue ear. The purpose of Tympanoplasty is to reconstruct TM perforation and restores sound conducting mechanism. In 1955, Zoellner and Wullstein used different types of graft materials for tympanoplasty. Later Heermann introduced cartilage palisade graft labeled as Simmering Technique. Similarly Goodhill also introduced first cartilage perichondrium composite graft material. Different graft materials can be used to close the TM defect. Some of these materials are temporalis fascia, tragal cartilage, perichondrium and fat. Temporalis fascia and tragal perichondrium had more anatomic proximity, compliance and translucency. The mode of action of these biological graft materials is that it provides support for the membrane remnant to proliferate and heal the defect. The temporalis fascia is thin, translucent and available in sufficient amount; but due to its close resemblance with tympanomeatal flap in color it may be displaced unintentionally during handling. However the reported success rate of temporalis fascia graft in literature varies from 93 to 97%.
On the other hand cartilage is middle ear friendly and survives for comparatively longer time due to the fact that its nourishment is based on diffusion process. Due to rigid nature of cartilage it prevents medialization of the graft to promontory in case of severe eustachian tube dysfunction. Cartilage graft is used in cases of chronically malfunction eustachian tube, adhesive otitis media, recurrent perforation and large TM perforation. But its demerits are its thick nature which hinders sound conduction and it is limited availability. The success rate of the cartilage graft tympanoplasty varies in the literature from 43 - 100%.
Chronic suppurative otitis media is an endemic health problem in our society. The reasons could be probably low literacy level, communities situated far flung from health facilities, lack of specialist service to the public in outreach area and inappropriate treatment of the middle ear infections. Sufficient number of patient suffering from inactive mucosal chronic otitis media with decreased hearing are presenting to otolaryngology unit. Tympanoplasty is the surgery of choice for chronic otitis media inactive mucosal type.
Hypothesis is that cartilage graft tympanoplasty is more successful than temporalis fascia tympanoplasty.
- Conditions
- Hearing Loss,Conductive
- Being tested
- Tympanoplasty using tragal cartilage graft, Tympanoplasty using temporalis fascia graft
- Keywords
- Cartilage, Hearing loss, Tympanoplasty
- Medical subject headings
- Hearing Loss, Conductive, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tympanoplasty using tragal cartilage graftProcedure or surgery
tympanoplasty type I is performed using tragal cartilage in arm 1
Tympanoplasty using temporalis fascia graftProcedure or surgery
tympanoplasty type I is performed using temporalis fascia in arm 2
| Study group | Role | What they receive |
|---|---|---|
| tympanoplasty with tragal cartilage | Active comparator | Tympanoplasty was performed using tragal cartilage graft Receives: Procedure: Tympanoplasty using tragal cartilage graft |
| tympanoplasty with temporalis fascia | Active comparator | Tympanoplasty was performed using temporalis fascia graft Receives: Procedure: Tympanoplasty using temporalis fascia graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft take up
the graft take rate is determined in both the groups
Measured: 06 months of follow up
Secondary outcomes (1)
Objective change in hearing level
Change in hearing level is objectively assessed by performing pure tone audiometry and that is recorded in decibels on audiogram
Measured: 03 months of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start1 Jan 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss,ConductiveStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Tympanoplasty I is performed in these patients in Group 1 tragal cartilage graft is used while in group 2 temporalis fascia graft is used
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lady Reading Hospital, Pakistan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fazal Wahid, Lady Reading Hospital, Pakistan
- Investigators
- Zahid Nazar, Study director, Lady Reading Hospital, Peshawar, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817242
- Sponsor's protocol ID
- LadyRH
- Acronym
- PTA
- Status last verified
- Jan 2019
- First submitted
- 28 Dec 2018
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: This data can be share with other researcher through indexed journal
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Half-thickness Tragal Cartilage Graft to Temporalis Fascia Graft
- ClinicalTrials.gov ID
- NCT03817242
- Acronym / sponsor ID
- PTA / LadyRH
- Conditions
- Hearing Loss,Conductive
- Keywords
- Cartilage, Hearing loss, Tympanoplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Lady Reading Hospital, PakistanOther government
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 25 Jan 2019 (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.
The rationale of this study is to find out the surgical outcome and success rates of tragal cartilage and temporalis fascia, subsequently to develop guide line in light of the results of this study for our department as our institute is going to follow one patient in one bed policy in future. The purpose of this study is to compare the graft success rate of cartilage versus temporalis fascia in tympanoplasty type I in our institute, as no such study has been conducted in our province before.
Detailed description
Tympanic membrane is forming lateral wall of the middle ear cleft which separates middle ear from the external auditory canal. It is made of three layers except in the upper part (Pars Flaccida). The outer layer of TM (Tympanic Membrane) is made of epithelium; middle layer is fibrous tissue, while inner layer is mucosal lining. The thickness of TM measures 0.1 mm, having diameter of 7-10 mm, weighing approximately 14 mg. The function of TM is to assist in hearing and protection of middle ear from infection. Perforation in tympanic membrane is the loss in continuity of TM layers. The causes of TM perforation may be trauma like blast, accident and firearm or infection of the middle ear like acute or chronic suppurative otitis media. It can also be iatrogenic as in case of placement of grommet for glue ear. The purpose of Tympanoplasty is to reconstruct TM perforation and restores sound conducting mechanism. In 1955, Zoellner and Wullstein used different types of graft materials for tympanoplasty. Later Heermann introduced cartilage palisade graft labeled as Simmering Technique. Similarly Goodhill also introduced first cartilage perichondrium composite graft material. Different graft materials can be used to close the TM defect. Some of these materials are temporalis fascia, tragal cartilage, perichondrium and fat. Temporalis fascia and tragal perichondrium had more anatomic proximity, compliance and translucency. The mode of action of these biological graft materials is that it provides support for the membrane remnant to proliferate and heal the defect. The temporalis fascia is thin, translucent and available in sufficient amount; but due to its close resemblance with tympanomeatal flap in color it may be displaced unintentionally during handling. However the reported success rate of temporalis fascia graft in literature varies from 93 to 97%.
On the other hand cartilage is middle ear friendly and survives for comparatively longer time due to the fact that its nourishment is based on diffusion process. Due to rigid nature of cartilage it prevents medialization of the graft to promontory in case of severe eustachian tube dysfunction. Cartilage graft is used in cases of chronically malfunction eustachian tube, adhesive otitis media, recurrent perforation and large TM perforation. But its demerits are its thick nature which hinders sound conduction and it is limited availability. The success rate of the cartilage graft tympanoplasty varies in the literature from 43 - 100%.
Chronic suppurative otitis media is an endemic health problem in our society. The reasons could be probably low literacy level, communities situated far flung from health facilities, lack of specialist service to the public in outreach area and inappropriate treatment of the middle ear infections. Sufficient number of patient suffering from inactive mucosal chronic otitis media with decreased hearing are presenting to otolaryngology unit. Tympanoplasty is the surgery of choice for chronic otitis media inactive mucosal type.
Hypothesis is that cartilage graft tympanoplasty is more successful than temporalis fascia tympanoplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Tympanoplasty I is performed in these patients in Group 1 tragal cartilage graft is used while in group 2 temporalis fascia graft is used
| Arm | Type | Receives |
|---|---|---|
| tympanoplasty with tragal cartilage | Active comparator | Procedure: Tympanoplasty using tragal cartilage graftTympanoplasty was performed using tragal cartilage graft |
| tympanoplasty with temporalis fascia | Active comparator | Procedure: Tympanoplasty using temporalis fascia graftTympanoplasty was performed using temporalis fascia graft |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- All patients of both genders in the age range 16 - 60 years.
- Inactive mucosal COM remained dry for at least one month.
- Conductive hearing loss with minimum air-bone gap (ABG) of 10 Decibel (dB).
- Middle ear is free of disease.
Key exclusion criteria (3 listed)
- Attic and / or posterior retraction pocket with cholesteatoma.
- Ossicular chain dysfunction and associated otogenic complication.
- Active mucosal COM.
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 |
|---|---|---|
| Tympanoplasty using tragal cartilage grafttympanoplasty type I is performed using tragal cartilage in arm 1 | Procedure or surgery | tympanoplasty with tragal cartilage |
| Tympanoplasty using temporalis fascia grafttympanoplasty type I is performed using temporalis fascia in arm 2 | Procedure or surgery | tympanoplasty with temporalis fascia |
Primary outcome
Graft take up
Time frame: 06 months of follow up
the graft take rate is determined in both the groups
1 secondary outcome
Objective change in hearing level
Time frame: 03 months of follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
- Individual participant dataSharing planned: Yes. This data can be share with other researcher through indexed journal
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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.
Zahid Nazar study director
Lady Reading Hospital, Peshawar, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tympanoplasty using tragal cartilage graft and Tympanoplasty using temporalis fascia graft in people with Hearing Loss,Conductive, run by Lady Reading Hospital, Pakistan at 1 site in Pakistan.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft take up (time frame: 06 months of follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2019.