Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04428463
Other study ID # EMC-13-20
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 30, 2020
Est. completion date June 2021

Study information

Verified date June 2020
Source HaEmek Medical Center, Israel
Contact lev shlizerman, md
Phone 00972504433469
Email lev_sh@clalit.org.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 27
Est. completion date June 2021
Est. primary completion date June 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Tachosil
tympanic membrane perforation repair using Tachosil patch under local anesthesia
fascia and cartilage
tympanic membrane perforation repair using fascia and cartilage under general anesthesia

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
HaEmek Medical Center, Israel

Outcome

Type Measure Description Time frame Safety issue
Primary closure of tympanic membrane perforation one month post operative the patient will be re-examined in the clinic to see if the perforation is closed. one month after the procedure
See also
  Status Clinical Trial Phase
Recruiting NCT04635228 - Biodesign® Otologic Repair Graft
Active, not recruiting NCT00222417 - Audiometric Parameters in Conductive Hearing Loss and Middle Ear Disease Phase 2/Phase 3
Recruiting NCT05086718 - Composite Cartilage Perichondrium Graft for Air Bone Gap Closure in Chronic Suppurative Otitis Media (CSOM) Without Posterior Meatal Flap N/A
Withdrawn NCT03904316 - Use of Biodesign® Otologic Graft in Tympanoplasty Phase 4
Completed NCT02307916 - Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations Phase 2
Terminated NCT01766856 - Eustachian Tube Function and Myringoplasty/Tympanoplasty N/A
Recruiting NCT06260618 - Effect of Chitodex Gel in Tympanoplasty Surgery N/A
Recruiting NCT04960384 - Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations Phase 2
Recruiting NCT03837665 - Efficacy of Platelet Enriched Plasma in Preventing Surgery for Patients With Chronic Tympanic Membrane Perforation Phase 1/Phase 2
Not yet recruiting NCT06257602 - Microscopic Versus Endoscopic Tympanoplasty
Completed NCT02550314 - A Study on the Regenerative Treatment of Tympanic Membrane With NPC-18 and FBG-18 Phase 3
Not yet recruiting NCT00310349 - PneuMum: Pneumococcal Vaccination of Australian Indigenous Mothers to See if it Protects Their Babies From Ear Disease Phase 3
Not yet recruiting NCT03416725 - Evaluation of Prognostic Factors in Tympanoplasty N/A
Completed NCT00714064 - PneuMum: Pneumococcal Vaccination of Australian Indigenous Mothers Phase 3
Completed NCT05605262 - Effects of 100% Medical Grade Manuka Honey on Tympanic Membrane Reconstruction Healing. Phase 2/Phase 3
Completed NCT02296944 - Anatomical and Functional Results of Surgery of the Tympanic Membrane Perforation of the Child N/A
Recruiting NCT05849844 - Tympanoseal Clinical Study N/A
Not yet recruiting NCT04687995 - Tragal Perichondrium Versus Pretragal Fascial (SMAS) Graft for Endoscopic Myringoplasty N/A
Completed NCT02120651 - Fibrin Monomer Compared With Hemostatic Sponge in the Integrity of the Graft During Tympanoplasty Phase 3
Withdrawn NCT03028272 - Hearing Results and Post Surgical Outcomes Using Amniotic Membrane Allograft vs. Fascia for Tympanoplasty N/A