Repair of Tympanic Membrane Perforation Using Tachosil Under Local Anesthesia

NCT ID: NCT04428463

Last Updated: 2020-06-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-30
• Study Completion Date: 2021-06-30

Brief Summary

Tympanic membrane perforations are common medical problem that encounters a lot of patients in all age groups.

The gold standard for treatment of perforations is tympanic membrane closure procedure (tympanoplasty) which is done under general anesthesia.

This procedure could be problematic for many patients who are not suitable for general anesthesia due to their medical status.

It's also time consuming for the patient and for the medical system, since it takes a lot of time to reach the operation room and hospitalization for at least two days.

The purpose in this study is to use Tachosil (Fibrinogen based patch) under local anesthesia to close tympanic membrane perforations.

Tachosil is in use for hemostasis and for tissue repair after injury. Tachosil is bound to the tissue and form a waterproof membrane. In the setting of ENT clinic and under local anesthesia, the investigators will start the procedure with debridement of the tympanic perforation edges, then they will close the perforation using two pieces of Tachosil under and above the perforation in the right form (active side to the active side).

If the results will be similar to tympanoplasty results, this method may be used for closure of tympanic perforation and save time and money for the patient and for the health system.

Detailed Description

Tympanoplasty is the gold standard treatment for tympanic membrane perforation.

It is done under general anesthesia in the following form:

Incision in the post auricular area, harvesting of fascia and cartilage from the concha of the pinna .

In Trans ear canal approach starting with debridement of the edges of the tympanic membrane perforation and closing the perforation using cartilage and fascia.

After being informed about the study and potential risks, all patients giving informed consent will participate in the study.

This study will include two groups. The first group will be treated with the conventional way as described above. The interventional group will be treated using Tachosil in the following order:

Local anesthesia using Lidocadren (lidocaine and epinephrine) will be injected to the ear canal using dental needle.

Debridement of the edges of the tympanic membrane perforation Placing the tachosil under and above the perforation in the correct order. The patient could be discharged home immediately after the procedure if no adverse effects are seen (dizziness, nausea or vomiting).

After one month, similar to the conventional treatment method, the patient will be invited to the otology clinic, for hearing test and microscopic examuntaion of the tympanic membrane, to see if the perforation is closed.

The study will compare the success rate in the two groups and if it will be similar that will help publish this method and use it in patients who are not suitable to general anesthesia and in hospitals were waiting time table for operation room is very long.

Conditions

Tympanic Membrane Perforation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tympanoplasty using fascia and cartilage

tympanoplasty under general anesthesia using fascia and cartilage witch is the gold standard for treating tympanic membrane perforations.

Group Type: ACTIVE_COMPARATOR

fascia and cartilage

Intervention Type: PROCEDURE

tympanic membrane perforation repair using fascia and cartilage under general anesthesia

Tachosil

repair of tympanic perforations under local anesthesia using Tachosil patch.

Group Type: EXPERIMENTAL

Tachosil

Intervention Type: PROCEDURE

tympanic membrane perforation repair using Tachosil patch under local anesthesia

Interventions

Tachosil

tympanic membrane perforation repair using Tachosil patch under local anesthesia

Intervention Type: PROCEDURE

fascia and cartilage

tympanic membrane perforation repair using fascia and cartilage under general anesthesia

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• chronic tympanic membrane perforation
• dry ear at least 4 weeks before the procedure
• no evidence of cholesteatoma
• hearing test in the last 3 months
• signing informed consent

Exclusion Criteria

• age under 18 years
• pregnant
• breastfeeding
• a known sensitivity for any ingredient
• a perforation that is more than one third of the tympanic membrane area.
• new onset perforation (less than 3 months)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HaEmek Medical Center, Israel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

lev shlizerman, md

Role: CONTACT

lev_sh@clalit.org.il

00972504433469

mary ghrayeb haddad, md

Role: CONTACT

mary_gh@clalit.org.il

00972509311771

Other Identifiers

EMC-13-20

Identifier Type: -

Identifier Source: org_study_id