Tympanic Membrane PerforationNCT04428463
Repair of Tympanic Membrane Perforation Using Tachosil Under Local Anesthesia
A study testing Tachosil and fascia and cartilage in people with Tympanic Membrane Perforation, run by HaEmek Medical Center, Israel.
Trial summary
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 under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tympanic Membrane Perforation
- What is being tested?
- Tachosil and fascia and cartilage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2020to Jun 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic tympanic membrane perforation
- dry ear at least 4 weeks before the procedure
- no evidence of cholesteatoma
- hearing test in the last 3 months
- signing informed consent
Who cannot join
- age under 18 years
- pregnant
- breastfeeding
- a known sensitivity for any ingredient
- a perforation that is more than one third of the tympanic membrane area.
- new onset perforation (less than 3 months)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Fibrinogen- Based Collagen Fleece Graft Myringoplasty for Chronic Tympanic Membrane Perforations - a Prospective Study
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 under general anesthesia.
Read more
This procedure could be problematic for many patients who are not suitable for general anesthesia due to their medical status.
It's also time consuming for the patient and for the medical system, since it takes a lot of time to reach the operation room and hospitalization for at least two days.
The purpose in this study is to use Tachosil (Fibrinogen based patch) under local anesthesia to close tympanic membrane perforations.
Tachosil is in use for hemostasis and for tissue repair after injury. Tachosil is bound to the tissue and form a waterproof membrane. In the setting of ENT clinic and under local anesthesia, the investigators will start the procedure with debridement of the tympanic perforation edges, then they will close the perforation using two pieces of Tachosil under and above the perforation in the right form (active side to the active side).
If the results will be similar to tympanoplasty results, this method may be used for closure of tympanic perforation and save time and money for the patient and for the health system.
Read the detailed description
Tympanoplasty is the gold standard treatment for tympanic membrane perforation.
It is done under general anesthesia in the following form:
Incision in the post auricular area, harvesting of fascia and cartilage from the concha of the pinna .
In Trans ear canal approach starting with debridement of the edges of the tympanic membrane perforation and closing the perforation using cartilage and fascia.
After being informed about the study and potential risks, all patients giving informed consent will participate in the study.
This study will include two groups. The first group will be treated with the conventional way as described above. The interventional group will be treated using Tachosil in the following order:
Local anesthesia using Lidocadren (lidocaine and epinephrine) will be injected to the ear canal using dental needle.
Debridement of the edges of the tympanic membrane perforation Placing the tachosil under and above the perforation in the correct order. The patient could be discharged home immediately after the procedure if no adverse effects are seen (dizziness, nausea or vomiting).
After one month, similar to the conventional treatment method, the patient will be invited to the otology clinic, for hearing test and microscopic examuntaion of the tympanic membrane, to see if the perforation is closed.
The study will compare the success rate in the two groups and if it will be similar that will help publish this method and use it in patients who are not suitable to general anesthesia and in hospitals were waiting time table for operation room is very long.
- Conditions
- Tympanic Membrane Perforation
- Being tested
- Tachosil, fascia and cartilage
- Keywords
- tympanic membrane perforation, tachosil, local anesthesia
- 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.
TachosilProcedure or surgery
tympanic membrane perforation repair using Tachosil patch under local anesthesia
fascia and cartilageProcedure or surgery
tympanic membrane perforation repair using fascia and cartilage under general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| tympanoplasty using fascia and cartilage | Active comparator | tympanoplasty under general anesthesia using fascia and cartilage witch is the gold standard for treating tympanic membrane perforations. Receives: Procedure: fascia and cartilage |
| Tachosil | Experimental | repair of tympanic perforations under local anesthesia using Tachosil patch. Receives: Procedure: Tachosil |
What is being measured
The primary outcome is the main question the study is designed to answer.
closure of tympanic membrane perforation
one month post operative the patient will be re-examined in the clinic to see if the perforation is closed.
Measured: one month after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start30 Jun 2020 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tympanic Membrane PerforationStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- two groups. In one we will use the conventional treatment strategy using tympanoplasty with fascia and cartilage. in the intervention group we will use tachosil in closing the perforations.
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04428463
- Sponsor's protocol ID
- EMC-13-20
- Status last verified
- Jun 2020
- First submitted
- 9 Jun 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibrinogen- Based Collagen Fleece Graft Myringoplasty for Chronic Tympanic Membrane Perforations - a Prospective Study
- ClinicalTrials.gov ID
- NCT04428463
- Acronym / sponsor ID
- EMC-13-20
- Conditions
- Tympanic Membrane Perforation
- Keywords
- tympanic membrane perforation, tachosil, local anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 30 Jun 2020 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 11 Jun 2020 (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.
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 under general anesthesia.
This procedure could be problematic for many patients who are not suitable for general anesthesia due to their medical status.
It's also time consuming for the patient and for the medical system, since it takes a lot of time to reach the operation room and hospitalization for at least two days.
The purpose in this study is to use Tachosil (Fibrinogen based patch) under local anesthesia to close tympanic membrane perforations.
Tachosil is in use for hemostasis and for tissue repair after injury. Tachosil is bound to the tissue and form a waterproof membrane. In the setting of ENT clinic and under local anesthesia, the investigators will start the procedure with debridement of the tympanic perforation edges, then they will close the perforation using two pieces of Tachosil under and above the perforation in the right form (active side to the active side).
If the results will be similar to tympanoplasty results, this method may be used for closure of tympanic perforation and save time and money for the patient and for the health system.
Detailed description
Tympanoplasty is the gold standard treatment for tympanic membrane perforation.
It is done under general anesthesia in the following form:
Incision in the post auricular area, harvesting of fascia and cartilage from the concha of the pinna .
In Trans ear canal approach starting with debridement of the edges of the tympanic membrane perforation and closing the perforation using cartilage and fascia.
After being informed about the study and potential risks, all patients giving informed consent will participate in the study.
This study will include two groups. The first group will be treated with the conventional way as described above. The interventional group will be treated using Tachosil in the following order:
Local anesthesia using Lidocadren (lidocaine and epinephrine) will be injected to the ear canal using dental needle.
Debridement of the edges of the tympanic membrane perforation Placing the tachosil under and above the perforation in the correct order. The patient could be discharged home immediately after the procedure if no adverse effects are seen (dizziness, nausea or vomiting).
After one month, similar to the conventional treatment method, the patient will be invited to the otology clinic, for hearing test and microscopic examuntaion of the tympanic membrane, to see if the perforation is closed.
The study will compare the success rate in the two groups and if it will be similar that will help publish this method and use it in patients who are not suitable to general anesthesia and in hospitals were waiting time table for operation room is very long.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two groups. In one we will use the conventional treatment strategy using tympanoplasty with fascia and cartilage. in the intervention group we will use tachosil in closing the perforations.
| Arm | Type | Receives |
|---|---|---|
| tympanoplasty using fascia and cartilage | Active comparator | Procedure: fascia and cartilagetympanoplasty under general anesthesia using fascia and cartilage witch is the gold standard for treating tympanic membrane perforations. |
| Tachosil | Experimental | Procedure: Tachosilrepair of tympanic perforations under local anesthesia using Tachosil patch. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- chronic tympanic membrane perforation
- dry ear at least 4 weeks before the procedure
- no evidence of cholesteatoma
- hearing test in the last 3 months
- signing informed consent
Key exclusion criteria (6 listed)
- age under 18 years
- pregnant
- breastfeeding
- a known sensitivity for any ingredient
- a perforation that is more than one third of the tympanic membrane area.
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 |
|---|---|---|
| Tachosiltympanic membrane perforation repair using Tachosil patch under local anesthesia | Procedure or surgery | Tachosil |
| fascia and cartilagetympanic membrane perforation repair using fascia and cartilage under general anesthesia | Procedure or surgery | tympanoplasty using fascia and cartilage |
Primary outcome
closure of tympanic membrane perforation
Time frame: one month after the procedure
one month post operative the patient will be re-examined in the clinic to see if the perforation is closed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Tachosil and fascia and cartilage in people with Tympanic Membrane Perforation, run by HaEmek Medical Center, Israel.
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 5 inclusion and 6 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 Jun 2020. 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 lev shlizerman, md (00972504433469, lev_sh@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
closure of tympanic membrane perforation (time frame: one month after the procedure). 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 16 Jun 2020.