Tympanic Membrane PerforationPhase 3TISSUCOLNCT02120651
Fibrin Monomer Compared With Hemostatic Sponge in the Integrity of the Graft During Tympanoplasty
A Phase 3 study testing Fibrin monomer and Hemostatic sponge in people with Tympanic Membrane Perforation, run by CLOTILDE FUENTES OROZCO at 1 site in Mexico.
Trial summary
The diagnosis of tympanic perforation reaches a high number of records in otorhinolaryngology services worldwide. Most of the tympanoplasties are performed in patients whose cause of perforation and hearing loss was chronic otitis media; this entity affects the population between 0.5 to 30% , the statistics mention… Read more about this study
- Who is it for?
- Ages 16 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Tympanic Membrane Perforation
- What is being tested?
- Fibrin monomer and Hemostatic sponge
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2012to Jan 2014
- Phase
- Phase 3
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed with tympanic perforation and with surgical indication of Tympanoplasty (without otorrhea for 6 months)
Who cannot join
- Background of tympanic perforation caused by allergic or pulmonary diseases including asthma and allergic rhinitis.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Western Medical Center, Mexican Institute of Social Security
Guadalajara, Jalisco, 44340
About this study
Official title: Effect of the Fibrin Monomer in the Integrity of the Graft During Tympanoplasty Compared With the Effect of the Hemostatic Sponge
The diagnosis of tympanic perforation reaches a high number of records in otorhinolaryngology services worldwide. Most of the tympanoplasties are performed in patients whose cause of perforation and hearing loss was chronic otitis media; this entity affects the population between 0.5 to 30% , the statistics mention more than 20 million people with this disease in the world. Since the introduction of tympanoplasty in the second half of the nineteenth century there have been numerous publications nationally and internationally about various experiences and new techniques. Including the use of fibrin monomer . This procedure is usually performed with the use of hemostatic sponge and recently with fibrin monomer, both materials are part of the basic input and surgical hemostatic agents. In this hospital are performed on average 110 tympanoplasty per year which has a percentage of non- integrity of the graft in the case of microscopic tympanoplasties using hemostatic sponge of 16% which is similar to the index of lack of integrity of the graft in microscopic tympanoplasties reported worldwide (18%), with the recent addition to the service of fibrin monomer, was necessary to evaluate if this material contributes to the integrity of the graft in microscopic tympanoplasty, as it has been reported in previous studies, so if there is found more integrity with this material, it can be recommended for routine use, improving the final prognosis of the patients.
Read the detailed description
Objective: Assess the effect of fibrin monomer in the integrity of the graft during tympanoplasties compared with the effect of the hemostatic sponge at the hospital of specialties Western Medical Center.
Material and Methods: Clinical trial with single blind, parallel-groups and randomized assignation. There were included patients with a diagnosis of tympanic perforation, candidates for surgical treatment by performing only microscopic tympanoplasties, which fulfilled the selection criteria. The main variable of the study was the integrity of the graft.
The statistical analysis was performed according to the nature of variables, for continuous data using measures of central tendency and dispersion and for the qualitative data with frequencies and percentages. To evaluate the effect of fibrin monomer relative to the hemostatic sponge, the data relating to the integrity of the graft between the groups were analyzed by chi-square.
- Conditions
- Tympanic Membrane Perforation
- Being tested
- Fibrin monomer, Hemostatic sponge
- Keywords
- Fibrin monomer, Tympanoplasty, Hemostatic sponge
- 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.
Fibrin monomerProcedure or surgery
Also called Tissucol
Fibrin monomer by microscopic tympanoplasty, every 4 weeks up to 3 months is evaluated graft integrity by standard audiologic and tympanometric parameters.
Hemostatic spongeProcedure or surgery
Hemostatic sponge by microscopic tympanoplasty, every 4 weeks up to 3 months is evaluated graft integrity by standard audiologic and tympanometric parameters.
| Study group | Role | What they receive |
|---|---|---|
| Fibrin monomer | Active comparator | 40 patients, the material was ready to use in the case of the fibrin monomer it was maintained in cooling according to the indications of lab maintenance and it was taken out a few minutes before using the material to prepare it according to instructional use and thus ensure that the conditions of maintenance of equipment are appropriate to the best outcome with their use. Receives: Procedure: Fibrin monomer |
| Hemostatic sponge | Placebo comparator | 40 patients, the material was ready to use in the case of the hemostatic sponge was cut into small size, prepared and impregnated with hydrocortisone as in the standard procedure. Receives: Procedure: Hemostatic sponge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Integrity of the graft
Integrity of the graft (100%) was evaluated by standard audiologic and tympanometric parameters.
Measured: every 4 weeks up to 3 months
Secondary outcomes (1)
Complications
Adhesions, granulomas and hearing loss
Measured: every 4 weeks up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startJan 2012
- Primary completionFeb 2013
- Study completionJan 2014
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- CLOTILDE FUENTES OROZCO
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, CLOTILDE FUENTES OROZCO, Instituto Mexicano del Seguro Social
- Investigators
- Clotilde Fuentes-Orozco, PhD, Study director, Instituto Mexicano del Seguro SocialLuis-Humberto Govea-Camacho, PhD, Principal investigator, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120651
- Sponsor's protocol ID
- TISSUCOL-012
- Acronym
- TISSUCOL
- Status last verified
- Apr 2014
- First submitted
- 21 Apr 2014
- Last updated
- 23 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Fibrin Monomer in the Integrity of the Graft During Tympanoplasty Compared With the Effect of the Hemostatic Sponge
- ClinicalTrials.gov ID
- NCT02120651
- Acronym / sponsor ID
- TISSUCOL / TISSUCOL-012
- Conditions
- Tympanic Membrane Perforation
- Keywords
- Fibrin monomer, Tympanoplasty, Hemostatic sponge
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- CLOTILDE FUENTES OROZCOOther government
- Study start
- Jan 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 23 Apr 2014 (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 diagnosis of tympanic perforation reaches a high number of records in otorhinolaryngology services worldwide. Most of the tympanoplasties are performed in patients whose cause of perforation and hearing loss was chronic otitis media; this entity affects the population between 0.5 to 30% , the statistics mention more than 20 million people with this disease in the world. Since the introduction of tympanoplasty in the second half of the nineteenth century there have been numerous publications nationally and internationally about various experiences and new techniques. Including the use of fibrin monomer . This procedure is usually performed with the use of hemostatic sponge and recently with fibrin monomer, both materials are part of the basic input and surgical hemostatic agents. In this hospital are performed on average 110 tympanoplasty per year which has a percentage of non- integrity of the graft in the case of microscopic tympanoplasties using hemostatic sponge of 16% which is similar to the index of lack of integrity of the graft in microscopic tympanoplasties reported worldwide (18%), with the recent addition to the service of fibrin monomer, was necessary to evaluate if this material contributes to the integrity of the graft in microscopic tympanoplasty, as it has been reported in previous studies, so if there is found more integrity with this material, it can be recommended for routine use, improving the final prognosis of the patients.
Detailed description
Objective: Assess the effect of fibrin monomer in the integrity of the graft during tympanoplasties compared with the effect of the hemostatic sponge at the hospital of specialties Western Medical Center.
Material and Methods: Clinical trial with single blind, parallel-groups and randomized assignation. There were included patients with a diagnosis of tympanic perforation, candidates for surgical treatment by performing only microscopic tympanoplasties, which fulfilled the selection criteria. The main variable of the study was the integrity of the graft.
The statistical analysis was performed according to the nature of variables, for continuous data using measures of central tendency and dispersion and for the qualitative data with frequencies and percentages. To evaluate the effect of fibrin monomer relative to the hemostatic sponge, the data relating to the integrity of the graft between the groups were analyzed by chi-square.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibrin monomer | Active comparator | Procedure: Fibrin monomer40 patients, the material was ready to use in the case of the fibrin monomer it was maintained in cooling according to the indications of lab maintenance and it was taken out a few minutes before using the material to prepare it according to instructional use and thus ensure that the conditions of maintenance of equipment are appropriate to the best outcome with their use. |
| Hemostatic sponge | Placebo comparator | Procedure: Hemostatic sponge40 patients, the material was ready to use in the case of the hemostatic sponge was cut into small size, prepared and impregnated with hydrocortisone as in the standard procedure. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with tympanic perforation and with surgical indication of Tympanoplasty (without otorrhea for 6 months)
Key exclusion criteria (1 listed)
- Background of tympanic perforation caused by allergic or pulmonary diseases including asthma and allergic rhinitis.
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 |
|---|---|---|
| Fibrin monomerAlso: TissucolFibrin monomer by microscopic tympanoplasty, every 4 weeks up to 3 months is evaluated graft integrity by standard audiologic and tympanometric parameters. | Procedure or surgery | Fibrin monomer |
| Hemostatic spongeHemostatic sponge by microscopic tympanoplasty, every 4 weeks up to 3 months is evaluated graft integrity by standard audiologic and tympanometric parameters. | Procedure or surgery | Hemostatic sponge |
Primary outcome
Integrity of the graft
Time frame: every 4 weeks up to 3 months
Integrity of the graft (100%) was evaluated by standard audiologic and tympanometric parameters.
1 secondary outcome
Complications
Time frame: every 4 weeks up to 3 months
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 23 Apr 2014.
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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.
Clotilde Fuentes-Orozco, PhD study director
Instituto Mexicano del Seguro Social
Luis-Humberto Govea-Camacho, PhD principal investigator
Instituto Mexicano del Seguro Social
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fibrin monomer and Hemostatic sponge in people with Tympanic Membrane Perforation, run by CLOTILDE FUENTES OROZCO at 1 site in Mexico.
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: finished, as of the sponsor's last update on 23 Apr 2014. 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 Mexico. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Integrity of the graft (time frame: every 4 weeks up to 3 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 23 Apr 2014.