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NCT03837665 Clinical Trial

Efficacy of Platelet Enriched Plasma in Preventing Surgery for Patients With Chronic Tympanic Membrane Perforation

Tympanic Membrane Perforation Clinical Trial

Official title:
Efficacy of Platelet Enriched Plasma in Preventing Surgery for Patients With Chronic Tympanic Membrane Perforation

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03837665
Other study ID # STUDY00140843
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date May 2, 2018
Est. completion date June 30, 2019

Study information
Verified date February 2019
Source University of Kansas Medical Center
Contact Kevin Sykes, PhD
Phone 913-588-7154
Email ksykes@kumc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

By doing this study, researchers hope to find out if platelet rich plasma (PRP) can heal holes in the eardrum as an alternative to surgery.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date June 30, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients who meet criteria for tympanoplasty procedure

- Willing to comply with the protocol and attend all study visits

- Able to provide written informed consent

Exclusion Criteria:

- Patients who have previously undergone middle ear or lateral skull base surgery

- Patients who would not qualify for a tympanoplasty

- Any type of platelet disorder, cancer, or ongoing systemic infection

- Any type of hemodynamic instability, septicemia, infection, tobacco use, any use of steroids to the ear drums

- Type I diabetes or other autoimmune pathology

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Platelet Rich Plasma
Platelet Rich Plasma (PRP) is blood plasma that has been enriched with platelets.

Locations
Country Name City State
United States University of Kansas Medical Center Kansas City Kansas

Sponsors (1)
Lead Sponsor Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevention of patients requiring surgery Number of participants that are able to avoid surgery for their perforation. 6 Weeks
Secondary Time to healing Size of perforation 6 Weeks
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