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

Primary Purpose

Tympanic Membrane Perforation

Status
Completed
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Fibrin monomer
Hemostatic sponge
Sponsored by
CLOTILDE FUENTES OROZCO
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tympanic Membrane Perforation focused on measuring Fibrin monomer, Tympanoplasty, Hemostatic sponge

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Western Medical Center, Mexican Institute of Social Security

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Fibrin monomer

Hemostatic sponge

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Integrity of the graft
Integrity of the graft (100%) was evaluated by standard audiologic and tympanometric parameters.

Secondary Outcome Measures

Complications
Adhesions, granulomas and hearing loss

Full Information

First Posted
April 21, 2014
Last Updated
April 22, 2014
Sponsor
CLOTILDE FUENTES OROZCO
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1. Study Identification

Unique Protocol Identification Number
NCT02120651
Brief Title
Fibrin Monomer Compared With Hemostatic Sponge in the Integrity of the Graft During Tympanoplasty
Acronym
TISSUCOL
Official Title
Effect of the Fibrin Monomer in the Integrity of the Graft During Tympanoplasty Compared With the Effect of the Hemostatic Sponge
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
CLOTILDE FUENTES OROZCO

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tympanic Membrane Perforation
Keywords
Fibrin monomer, Tympanoplasty, Hemostatic sponge

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fibrin monomer
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Hemostatic sponge
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Fibrin monomer
Other Intervention Name(s)
Tissucol
Intervention Description
Fibrin monomer by microscopic tympanoplasty, every 4 weeks up to 3 months is evaluated graft integrity by standard audiologic and tympanometric parameters.
Intervention Type
Procedure
Intervention Name(s)
Hemostatic sponge
Intervention Description
Hemostatic sponge by microscopic tympanoplasty, every 4 weeks up to 3 months is evaluated graft integrity by standard audiologic and tympanometric parameters.
Primary Outcome Measure Information:
Title
Integrity of the graft
Description
Integrity of the graft (100%) was evaluated by standard audiologic and tympanometric parameters.
Time Frame
every 4 weeks up to 3 months
Secondary Outcome Measure Information:
Title
Complications
Description
Adhesions, granulomas and hearing loss
Time Frame
every 4 weeks up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clotilde Fuentes-Orozco, PhD
Organizational Affiliation
Instituto Mexicano del Seguro Social
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Luis-Humberto Govea-Camacho, PhD
Organizational Affiliation
Instituto Mexicano del Seguro Social
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Medical Center, Mexican Institute of Social Security
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico

12. IPD Sharing Statement

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

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