Tympanic Membrane PerforationNCT03028272
Hearing Results and Post Surgical Outcomes Using Amniotic Membrane Allograft vs. Fascia for Tympanoplasty
A study testing Skye Barrier and Fascia in people with Tympanic Membrane Perforation, run by University of Missouri-Columbia.
Trial summary
The trial seeks to provide evidence that the Skye ActiveBarrier provides similar surgical and functional outcomes as fascia when used for tympanoplasties while offering benefits including reduced operative time, better patient satisfaction, and fewer complications. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Tympanic Membrane Perforation
- What is being tested?
- Skye Barrier and Fascia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Dec 2020
- 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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Presence of a tympanic membrane perforation
- Patient at PI's clinic
Who cannot join
- Presence of cholesteatoma
- Prior surgery on the same-sided TM or middle ear
- Ossicular chain abnormalities
- Congenital deformities involving the middle ear or eustachian tube
- Refusal to undergo surgery
About this study
Official title: Hearing Results and Post Surgical Outcomes Using Amniotic Membrane Allograft Versus Fascia for Tympanoplasty: A Randomized Prospective Trial
The trial seeks to provide evidence that the Skye ActiveBarrier provides similar surgical and functional outcomes as fascia when used for tympanoplasties while offering benefits including reduced operative time, better patient satisfaction, and fewer complications.
Read the detailed description
A prospective randomized controlled trial will be conducted. Eligible patients will be identified, recruited and randomized to receive either repair using the standard fascia graft or repair using the Skye ActiveBarrier. Subjects will undergo a preoperative evaluation followed by TM repair and subsequent regular office visits to assess functional outcomes, complications, and satisfaction. Patients will be blinded to the substrate used for their repair. As there are two different approaches for a tympanoplasty (through the ear canal or incision behind the ear) based on the subject's ear anatomy and location of the perforation, a sham surgery will not be necessary to disguise which graft is received. At follow up visits, photos may be taken of patients' TMs and these photos will be evaluated for healing by an otologist who did not conduct the surgery in a blinded fashion. At the 1 year follow up appointment, subjects will be told which substrate they received and at the study's conclusion subjects will notified about the study's findings.
- Conditions
- Tympanic Membrane Perforation
- Being tested
- Skye Barrier, Fascia
- Keywords
- tympanic membrane perforation
- 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.
Skye BarrierOther
Substrate derived from amniotic tissue that is FDA-approved for human implantation
FasciaOther
Autologous donor substrate. Examples include tragal cartilage, perichondrium, temporalis fascia, and temporoparietal fascia
| Study group | Role | What they receive |
|---|---|---|
| Fascia | Active comparator | Autologous donor substrate Receives: Other: Fascia |
| Skye Barrier | Experimental | Amniotic membrane allograft Receives: Other: Skye Barrier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparable or improved performance of Skye ActiveBarrier
Comparable or improved performance will be assessed by combining data from 6 specific measurements: air and bone gap audiogram, word recognition score via audiogram, number of surgical/post-surgical complications, operating time and healing time.
Measured: 12-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start1 Jan 2017
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Why it stopped: Lack of qualified participants
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.
- More trials run by University of Missouri-ColumbiaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arnaldo L. Rivera, University of Missouri-Columbia
- Investigators
- Arnaldo Rivera, M.D., Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028272
- Sponsor's protocol ID
- 2006074
- Status last verified
- Apr 2021
- First submitted
- 18 Jan 2017
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not intend to share individual participant data to other researchers. Analyzed data will be published in peer-review journal.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hearing Results and Post Surgical Outcomes Using Amniotic Membrane Allograft Versus Fascia for Tympanoplasty: A Randomized Prospective Trial
- ClinicalTrials.gov ID
- NCT03028272
- Acronym / sponsor ID
- 2006074
- Conditions
- Tympanic Membrane Perforation
- Keywords
- tympanic membrane perforation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of qualified participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 23 Jan 2017 (estimated)
- 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 trial seeks to provide evidence that the Skye ActiveBarrier provides similar surgical and functional outcomes as fascia when used for tympanoplasties while offering benefits including reduced operative time, better patient satisfaction, and fewer complications.
Detailed description
A prospective randomized controlled trial will be conducted. Eligible patients will be identified, recruited and randomized to receive either repair using the standard fascia graft or repair using the Skye ActiveBarrier. Subjects will undergo a preoperative evaluation followed by TM repair and subsequent regular office visits to assess functional outcomes, complications, and satisfaction. Patients will be blinded to the substrate used for their repair. As there are two different approaches for a tympanoplasty (through the ear canal or incision behind the ear) based on the subject's ear anatomy and location of the perforation, a sham surgery will not be necessary to disguise which graft is received. At follow up visits, photos may be taken of patients' TMs and these photos will be evaluated for healing by an otologist who did not conduct the surgery in a blinded fashion. At the 1 year follow up appointment, subjects will be told which substrate they received and at the study's conclusion subjects will notified about the study's findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fascia | Active comparator | Other: FasciaAutologous donor substrate |
| Skye Barrier | Experimental | Other: Skye BarrierAmniotic membrane allograft |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Presence of a tympanic membrane perforation
- Patient at PI's clinic
Key exclusion criteria (5 listed)
- Presence of cholesteatoma
- Prior surgery on the same-sided TM or middle ear
- Ossicular chain abnormalities
- Congenital deformities involving the middle ear or eustachian tube
- Refusal to undergo surgery
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 |
|---|---|---|
| Skye BarrierSubstrate derived from amniotic tissue that is FDA-approved for human implantation | Other | Skye Barrier |
| FasciaAutologous donor substrate. Examples include tragal cartilage, perichondrium, temporalis fascia, and temporoparietal fascia | Other | Fascia |
Primary outcome
Comparable or improved performance of Skye ActiveBarrier
Time frame: 12-18 months
Comparable or improved performance will be assessed by combining data from 6 specific measurements: air and bone gap audiogram, word recognition score via audiogram, number of surgical/post-surgical complications, operating time and healing time.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Individual participant dataSharing planned: No. The investigators do not intend to share individual participant data to other researchers. Analyzed data will be published in peer-review 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.
Arnaldo Rivera, M.D. principal investigator
University of Missouri-Columbia
Questions about this trial
What is this clinical trial studying?
A study testing Skye Barrier and Fascia in people with Tympanic Membrane Perforation, run by University of Missouri-Columbia.
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 2 inclusion and 5 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: withdrawn, as of the sponsor's last update on 15 Apr 2021. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Comparable or improved performance of Skye ActiveBarrier (time frame: 12-18 months). 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 15 Apr 2021.