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

Phase 3

Completed

• Conditions: Tympanic Membrane Perforation
• Interventions: Procedure: Hemostatic sponge; Procedure: Fibrin monomer

• Registration Number: NCT02120651
• Lead Sponsor: CLOTILDE FUENTES OROZCO

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.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2013-02
• Study Completion: 2014-01
• Status Verified: 2014-04
• Study First Submitted: 2014-04-21
• Study First Submitted QC: 2014-04-22
• Last Update Submitted: 2014-04-22
• Study First Posted: 2014-04-23
• Last Update Posted: 2014-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hemostatic sponge	Hemostatic sponge	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.
Fibrin monomer	Fibrin monomer	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.

Primary Outcome Measures

Name	Time	Method
Integrity of the graft	every 4 weeks up to 3 months	Integrity of the graft (100%) was evaluated by standard audiologic and tympanometric parameters.

Secondary Outcome Measures

Name	Time	Method
Complications	every 4 weeks up to 3 months	Adhesions, granulomas and hearing loss

Trial Locations

Locations (1)

Western Medical Center, Mexican Institute of Social Security; 🇲🇽 Guadalajara, Jalisco, Mexico