Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66160

More Details

Status
Recruiting
Sponsor
University of Kansas Medical Center

Study Contact

Kevin Sykes, PhD
913-588-7154
ksykes@kumc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.