Efficacy of Platelet Enriched Plasma in Preventing Surgery for Patients With Chronic Tympanic Membrane Perforation
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|ClinicalTrials.gov Identifier: NCT03837665|
Recruitment Status : Unknown
Verified February 2019 by Hinrich Staecker, MD, PhD, University of Kansas Medical Center.
Recruitment status was: Recruiting
First Posted : February 12, 2019
Last Update Posted : March 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Tympanic Membrane Perforation||Biological: Platelet Rich Plasma||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Platelet Enriched Plasma in Preventing Surgery for Patients With Chronic Tympanic Membrane Perforation|
|Actual Study Start Date :||May 2, 2018|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||June 30, 2019|
Experimental: PRP Treatment
Participants receive platelet rich plasma treatment. Participants will be asked to make up to 5 trips to the clinic (one for eligibility, one for the PRP, three follow-up visits). Participation is expected to last up to about 6 weeks. After the second visit and application of PRP, patients will be monitored closely for any complications or concerns. This will include a follow up phone call 3-5 days after the initial application of PRP. Patients will also be followed closely in 2 week intervals or sooner should any problems or concerns arise.
Biological: Platelet Rich Plasma
Platelet Rich Plasma (PRP) is blood plasma that has been enriched with platelets.
Other Name: PRP
- Prevention of patients requiring surgery [ Time Frame: 6 Weeks ]Number of participants that are able to avoid surgery for their perforation.
- Time to healing [ Time Frame: 6 Weeks ]Size of perforation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03837665
|Contact: Kevin Sykes, PhDfirstname.lastname@example.org|
|Contact: Bryan Humphreyemail@example.com|
|United States, Kansas|
|University of Kansas Medical Center||Recruiting|
|Kansas City, Kansas, United States, 66160|
|Sub-Investigator: Matthew Shew, MD|
|Sub-Investigator: Kevin Sykes, PhD|
|Principal Investigator:||Hinrich Staecker, MD||University of Kansas Medical Center|