Repair of Tympanic Membrane Perforation Using Tachosil Under Local Anesthesia

NCT04428463 | Unknown

• 1 other identifier: EMC-13-20
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tympanic Membrane Perforation

Keywords

tympanic membrane perforation; tachosil; local anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

tympanoplasty using fascia and cartilage

ACTIVE COMPARATOR

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

Procedure: fascia and cartilage

Tachosil

EXPERIMENTAL

repair of tympanic perforations under local anesthesia using Tachosil patch.

Procedure: Tachosil

Interventions

Tachosil PROCEDURE

tympanic membrane perforation repair using Tachosil patch under local anesthesia

Tachosil

fascia and cartilage PROCEDURE

tympanic membrane perforation repair using fascia and cartilage under general anesthesia

tympanoplasty using fascia and cartilage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

MeSH Terms

Conditions

Tympanic Membrane Perforation

Interventions

TachoSil

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Wounds and Injuries

Central Study Contacts

lev shlizerman, md

CONTACT

00972504433469; lev_sh@clalit.org.il

mary ghrayeb haddad, md

CONTACT

00972509311771; mary_gh@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: two groups. In one we will use the conventional treatment strategy using tympanoplasty with fascia and cartilage. in the intervention group we will use tachosil in closing the perforations.

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 11, 2020
• Study Start: June 30, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: June 16, 2020

Record last verified: 2020-06