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Evaluating effect of PRP-enriched gelfoam on healing of Tympanic membrane rupture

Comparing the Effect of PRP-enriched Gelfoam and Conventional Gelfoam on the Healing of Chronic Tympanic Membrane Perforation; A Double-blind Randomized Clinical Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016083017413N16
Enrollment
30
Registered
2016-09-12
Start date
2016-09-22
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

Tympanic Membrane Perforation. Perforation of tympanic membrane

Interventions

Intervention 1: After transferring the patient to operation room and before presence of surgeon, 8 ml of blood will be obtained from patient’s brachial vein in intervention group and will be stored in
Treatment - Surgery
After transferring the patient to operation room and before presence of surgeon, 8 ml of blood will be obtained from patient’s brachial vein in intervention group and will be stored in PRP kits (Regen
After transferring the patient to operation room and before presence of surgeon, small (1 and 2- mm) and two large (1 to 2 mm more than size of perforation) gel foams will be prepared and will be imp

Sponsors

Baqiyatallah University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: patients with ages between 18 and 60 years old who were candidates for type I Tympanoplasty were enrolled in the study. Patients with active otorrhea, cholesteatoma, canal stenosis, TM perforation more than 5 mm, autoimmune and hematologic diseases, active neoplasm, immunosuppressive treatment and diabetes as well as smokers were excluded from the study.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Healing of Tympanic Membrane. Timepoint: 2 and 3 months after intervention. Method of measurement: Hook tool.;Tympanic Membrane Rupture. Timepoint: Before Intervention. Method of measurement: Hook tool.

Secondary

MeasureTime frame
Side Effects. Timepoint: 2 and 3 months after intervention. Method of measurement: History and Examination.;Treatment Cost. Timepoint: After Intervention. Method of measurement: Receipt.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Hossein Khosravi

Students' Research Committee, Baqiyatallah University of Medical Sciences, Tehran, Iran

dr.mhkhosravi@gmail.com+98 21 8862 0826

Outcome results

None listed

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