Clinical application of embryonic membrane in middle ear surgery

Clinical application of an amniotic membrane in canal wall down tympanomastoidectomy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015081915496N16

Enrollment

150

Registered

2017-05-07

Start date

2017-04-21

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

choronic otitis media with choleasteaoma. Chronic atticoantral suppurative otitis media, Other chronic suppurative otitis media,Suppurative otitis media, unspecified,Chronic mastoiditis

Interventions

Intervention 1: The aminiotic membrane used for coverage of muscle flap in intervention group. Intervention 2: The aminiotic membrane did not used for coverage of muscle flap in control group.

Treatment - Surgery

The aminiotic membrane used for coverage of muscle flap in intervention group.

The aminiotic membrane did not used for coverage of muscle flap in control group.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria: all patients more than 18 years old; canal wall down mastoidectomy because of choronic otitis media with choleastetoma; final size of tympanic membrane perforation more than 50%. Exclusion criteria: revision surgery; pre operative medical problems such as asthma, diabetes, coagulation disorders, cardiovascular disease, basic metabolic disorder and chronic liver or renal disease; patients without adequate follow up (less than 6 months); canal wall down mastoidectomy because of other reason such as tumors.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Tympanic membrane graft successes rate. Timepoint: within 6 months after surgery. Method of measurement: Observation by physician.;Epithelialization. Timepoint: within 6 months after surgery. Method of measurement: Observation by physician.;Otorrhea. Timepoint: within 6 months after surgery. Method of measurement: Observation by physician.;Existance granulation tissue. Timepoint: within 6 months after surgery. Method of measurement: Observation by physician.;Hearing threshold. Timepoint: before operation -6 months after operation. Method of measurement: pure tone audiometry.	—

Measure

Time frame

Tympanic membrane graft successes rate. Timepoint: within 6 months after surgery. Method of measurement: Observation by physician.;Epithelialization. Timepoint: within 6 months after surgery. Method of measurement: Observation by physician.;Otorrhea. Timepoint: within 6 months after surgery. Method of measurement: Observation by physician.;Existance granulation tissue. Timepoint: within 6 months after surgery. Method of measurement: Observation by physician.;Hearing threshold. Timepoint: before operation -6 months after operation. Method of measurement: pure tone audiometry.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSareh Roosta

Department of Otolaryngology, Shiraz University of Medical Sciences

Roosta.Sareh@gmail.com+98 71 3629 1478

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026