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

NCT02120651 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2014-04-23

No results posted yet for this study

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.

Conditions

  • Tympanic Membrane Perforation

Interventions

PROCEDURE

Fibrin monomer

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

PROCEDURE

Hemostatic sponge

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

Sponsors & Collaborators

  • CLOTILDE FUENTES OROZCO

    lead OTHER_GOV

Principal Investigators

  • Clotilde Fuentes-Orozco, PhD · Instituto Mexicano del Seguro Social

  • Luis-Humberto Govea-Camacho, PhD · Instituto Mexicano del Seguro Social

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-02-28
Completion
2014-01-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02120651 on ClinicalTrials.gov