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Fibrin Monomer Compared With Hemostatic Sponge in the Integrity of the Graft During Tympanoplasty

Effect of the Fibrin Monomer in the Integrity of the Graft During Tympanoplasty Compared With the Effect of the Hemostatic Sponge

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02120651
Acronym
TISSUCOL
Enrollment
80
Registered
2014-04-23
Start date
2012-01-31
Completion date
2014-01-31
Last updated
2014-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tympanic Membrane Perforation

Keywords

Fibrin monomer, Tympanoplasty, Hemostatic sponge

Brief 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 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.

Interventions

PROCEDUREFibrin monomer

Fibrin monomer by microscopic tympanoplasty, every 4 weeks up to 3 months is evaluated graft integrity by standard audiologic and tympanometric parameters.

PROCEDUREHemostatic sponge

Hemostatic sponge by microscopic tympanoplasty, every 4 weeks up to 3 months is evaluated graft integrity by standard audiologic and tympanometric parameters.

Sponsors

CLOTILDE FUENTES OROZCO
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients diagnosed with tympanic perforation and with surgical indication of Tympanoplasty (without otorrhea for 6 months)

Exclusion criteria

* Background of tympanic perforation caused by allergic or pulmonary diseases including asthma and allergic rhinitis.

Design outcomes

Primary

MeasureTime frameDescription
Integrity of the graftevery 4 weeks up to 3 monthsIntegrity of the graft (100%) was evaluated by standard audiologic and tympanometric parameters.

Secondary

MeasureTime frameDescription
Complicationsevery 4 weeks up to 3 monthsAdhesions, granulomas and hearing loss

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026