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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
Sponsor:
Information provided by (Responsible Party):
Hinrich Staecker, MD, PhD, University of Kansas Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Tympanic Membrane Perforation Biological: Platelet Rich Plasma Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

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 Name: PRP




Primary Outcome Measures :
  1. Prevention of patients requiring surgery [ Time Frame: 6 Weeks ]
    Number of participants that are able to avoid surgery for their perforation.


Secondary Outcome Measures :
  1. Time to healing [ Time Frame: 6 Weeks ]
    Size of perforation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Kevin Sykes, PhD 913-588-7154 ksykes@kumc.edu
Contact: Bryan Humphrey bhumphrey@kumc.edu

Locations
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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         
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
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Principal Investigator: Hinrich Staecker, MD University of Kansas Medical Center
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Responsible Party: Hinrich Staecker, MD, PhD, Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03837665    
Other Study ID Numbers: STUDY00140843
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019

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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
Keywords provided by Hinrich Staecker, MD, PhD, University of Kansas Medical Center:
Platelet Rich Plasma
TM perforations
Hearing loss
Hole in the eardrum
Additional relevant MeSH terms:
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Tympanic Membrane Perforation
Ear Diseases
Otorhinolaryngologic Diseases
Wounds and Injuries