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

February 27, 2019 updated by: Hinrich Staecker, MD, PhD, University of Kansas Medical Center
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
        • Sub-Investigator:
          • Matthew Shew, MD
        • Sub-Investigator:
          • Kevin Sykes, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • PRP

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to healing
Time Frame: 6 Weeks
Size of perforation
6 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Investigators

  • Principal Investigator: Hinrich Staecker, MD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2018

Primary Completion (Anticipated)

June 30, 2019

Study Completion (Anticipated)

June 30, 2019

Study Registration Dates

First Submitted

February 8, 2019

First Submitted That Met QC Criteria

February 8, 2019

First Posted (Actual)

February 12, 2019

Study Record Updates

Last Update Posted (Actual)

March 1, 2019

Last Update Submitted That Met QC Criteria

February 27, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00140843

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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