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Clinical Trials/NCT02120651
NCT02120651
Completed
Phase 3

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

CLOTILDE FUENTES OROZCO1 site in 1 country80 target enrollmentJanuary 2012

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Tympanic Membrane Perforation
Sponsor
CLOTILDE FUENTES OROZCO
Enrollment
80
Locations
1
Primary Endpoint
Integrity of the graft
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
January 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
CLOTILDE FUENTES OROZCO
Responsible Party
Sponsor Investigator
Principal Investigator

CLOTILDE FUENTES OROZCO

PhD

Instituto Mexicano del Seguro Social

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Complications(every 4 weeks up to 3 months)

Study Sites (1)

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