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tympanoplasty results using gelfoam block , autologus fat and mix of fat and gelfoam in Chronic Otitis Media

Comparison of tympanoplasty results using gelfoam block support, autologus fat blocks and mix of fat and gelfoam blocks in Chronic Otitis Media: A Clinical Trial studyl

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220608055103N1
Enrollment
96
Registered
2022-10-04
Start date
2022-07-23
Completion date
Unknown
Last updated
2022-11-21

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

Conditions

Chronic Otitis Media. Central perforation of tympanic membrane

Interventions

Intervention 1: Intervention group: , gelfoam is used in group A. Intervention 2: Intervention group: Fat block is used in group B.In order to prepare fat blocks, about 0.5 to 1 cubic centimeter is r

Sponsors

Rasht University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: All patients with chronic otitis media with simple TM perforation and the age range of 18 to 65 years

Exclusion criteria

Exclusion criteria: ABG > 40 db ossicular disorders Evidence of cholesteatoma Complete perforation without edge (at least 2 mm) TM Active otorrhea during recent a month Presence of large and thick plaques of tympanosclerosis in the edges of perforation underlying diseases such as diabetes, hypothyroidy, severe uremia, bleeding diseases, immunodeficiency diseases smoking Evidence in favor of Eustachian tube disorder, such as bilateral perforation, bilateral otorrhea, atelectatic ears, etc

Design outcomes

Primary

MeasureTime frame
Link success rate. Timepoint: before surgery and 3 months after surgery. Method of measurement: Pure tone audiometry at frequencies of 512, 1024, 2048 Hz is used to measure ABG, and tympanogram and the amount and location of its peak (types A, B, C) are used to check the health of the new tympanic membrane.

Secondary

MeasureTime frame
(ABG rate ) air bone gap. Timepoint: before surgery and 3 months after surgery. Method of measurement: Pure tone audiometry at frequencies of 512, 1024, 2048 Hz is used to measure chatter, and tympanogram and the amount and location of its peak (types A, B, C) are used to check the health of the new tympanic membrane.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShadman Nemati

Rasht University of Medical Sciences

drshadmannemati_ent@yahoo.com+98 13 3322 5242

Outcome results

None listed

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