NCT02120651

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 23, 2014

Completed
Last Updated

April 23, 2014

Status Verified

April 1, 2014

Enrollment Period

1.1 years

First QC Date

April 21, 2014

Last Update Submit

April 22, 2014

Conditions

Tympanic Membrane Perforation

Keywords

Fibrin monomerTympanoplastyHemostatic sponge

Outcome Measures

Primary Outcomes (1)

  • Integrity of the graft

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

    every 4 weeks up to 3 months

Secondary Outcomes (1)

  • Complications

    every 4 weeks up to 3 months

Study Arms (2)

Fibrin monomer

ACTIVE COMPARATOR

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.

Procedure: Fibrin monomer

Hemostatic sponge

PLACEBO COMPARATOR

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.

Procedure: Hemostatic sponge

Interventions

Fibrin monomerPROCEDURE

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

Also known as: Tissucol
Fibrin monomer
Hemostatic spongePROCEDURE

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

Hemostatic sponge

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Medical Center, Mexican Institute of Social Security

Guadalajara, Jalisco, 44340, Mexico

Location

MeSH Terms

Conditions

Tympanic Membrane Perforation

Interventions

fibrinmonomerFibrin Tissue Adhesive

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic DiseasesWounds and Injuries

Intervention Hierarchy (Ancestors)

FibrinBlood ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Clotilde Fuentes-Orozco, PhD

    Instituto Mexicano del Seguro Social

    STUDY DIRECTOR

  • Luis-Humberto Govea-Camacho, PhD

    Instituto Mexicano del Seguro Social

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

April 21, 2014

First Posted

April 23, 2014

Study Start

January 1, 2012

Primary Completion

February 1, 2013

Study Completion

January 1, 2014

Last Updated

April 23, 2014

Record last verified: 2014-04

Locations

ME(1)