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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 30, 2019

Interventions

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

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Prevention of patients requiring surgery
    • Time Frame: 6 Weeks
    • Number of participants that are able to avoid surgery for their perforation.

Secondary Measures

  • Time to healing
    • Time Frame: 6 Weeks
    • Size of perforation

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Kansas Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hinrich Staecker, MD, PhD, Professor – University of Kansas Medical Center
  • Overall Official(s)
    • Hinrich Staecker, MD, Principal Investigator, University of Kansas Medical Center
  • Overall Contact(s)
    • Kevin Sykes, PhD, 913-588-7154, ksykes@kumc.edu

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