Efficacy of Platelet Enriched Plasma in Preventing Surgery for Patients With Chronic Tympanic Membrane Perforation
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
- Tympanic Membrane Perforation
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
| Arm | Description | Assigned 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. |
|
Recruiting Locations
University of Kansas Medical Center
Kansas City, Kansas 66160
Kansas City, Kansas 66160
More Details
- Status
- Unknown status
- Sponsor
- University of Kansas Medical Center