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

University of Kansas

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Tympanic Membrane Perforation

Treatments: Biological: Platelet Rich Plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT03837665

STUDY00140843

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1 participants in 1 patient group

PRP Treatment

Experimental group

Description:

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.

Treatment:

Biological: Platelet Rich Plasma