Fibrin Monomer Compared With Hemostatic Sponge in the Integrity of the Graft During Tympanoplasty
Condition: Tympanic Membrane Perforation
MeSH terms: Tympanic Membrane Perforation
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Fibrin monomer; Hemostatic sponge
Intervention type(s): Procedure; Procedure
Intervention description(s): Fibrin monomer by microscopic tympanoplasty, every 4 weeks up to 3 months is evaluated graft integrity by standard audiologic and tympanometric parameters.; Hemostatic sponge by microscopic tympanoplasty, every 4 weeks up to 3 months is evaluated graft integrity by standard audiologic and tympanometric parameters.
Other intervention name(s): Tissucol
Intervention MeSH terms: Hemostatics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Fibrin monomer; Tympanoplasty; Hemostatic sponge