Comparing the Effect of PRP-enriched Gelfoam and Conventional Gelfoam on the Healing of Chronic Tympanic Membrane Perforation; A Double-blind Randomized Clinical Trial
In the present study we aim to evaluate the effect of PRP-enriched gelfoam on the healing of chronic TM perforation in comparison with gelfoam alone.
In this Double-blind randomized clinical trial Patients with chronic tympanic membrane rupture attending to Otolaryngology clinic with ages between 18 and 60 years old who are candidates for type I Tympanoplasty will be 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 will be excluded from the study. Patients will be randomly allocated to two groups; intervention group will undergo Tympanoplasty with platelet rich plasma (PRP)-enriched gel foams and control group will undergo operation with conventional gel foams alone. In the first post operational visit, three days after intervention, wound dressing and mesh were disposed. Patients’ information was recorded 2 and 3 months after surgery and underwent analysis by a statistician.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016083017413N16
Registration date:2016-09-12, 1395/06/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-09-12, 1395/06/22
Registrant information
Name
Hamidreza Karimi-Sari
Name of organization / entity
Student Research Committee, Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 4354
Email address
hrkarimisari@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Baqiyatallah University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effect of PRP-enriched Gelfoam and Conventional Gelfoam on the Healing of Chronic Tympanic Membrane Perforation; A Double-blind Randomized Clinical Trial
Public title
Evaluating effect of PRP-enriched gelfoam on healing of Tympanic membrane rupture
Purpose
Treatment
Inclusion/Exclusion 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.
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 (RegenKit BCT). Samples will be centrifuged in room’s temperature by 3000 rounds/min in 5 minutes then 3 ml of the resulting solution will be disposed from the top of the kit. Based on factory’s instruction, the remaining solution will be shaken for obtaining 1ml of high density and homogenous PRP. In the following, small (1 and 2- mm) and two large (1 to 2 mm more than size of perforation) gel foams will be prepared and enriched with PRP in galipot. In control group gel foams will be impregnated with normal saline for blinding purpose. Then surgeon, who is not aware of added material to gel foams, will be paged to the OR. After convenient prep and drep 1 ml of Lidocaine 2% will be injected to ear canal using insulin syringe. Following anesthesia, sharp rosen will be used for trimming of TM perforation margins and gel foams will be put in the middle ear. Then one of the large gel foams will be located in middle ear, under TM, and another one will be fixed in ear canal on the TM. Ear canal will be filled with small gel foams and Tetracycline mesh and wound dressing will be done using one gauze and surgifix. After operation, patients will be visited in recovery room and will be discharged with oral cephalexin.
Category
Treatment - Surgery
2
Description
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 impregnated with normal saline for blinding purpose. Then surgeon, who is not aware of added material to gel foams, will be paged to the OR. After convenient prep and drep 1 ml of Lidocaine 2% will be injected to ear canal using insulin syringe. Following anesthesia, sharp rosen will be used for trimming of TM perforation margins and gel foams will be put in the middle ear. Then one of the large gel foams will be located in middle ear, under TM, and another one will be fixed in ear canal on the TM. Ear canal will be filled with small gel foams and Tetracycline mesh and wound dressing will be done using one gauze and surgifix. After operation, patients will be visited in recovery room and will be discharged with oral cephalexin.