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

Phase 1

Terminated

• Conditions: Tympanic Membrane Perforation
• Interventions: Biological: Platelet Rich Plasma

• Registration Number: NCT03837665
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-02
• Study First Submitted: 2019-02-08
• Study First Submitted QC: 2019-02-08
• Study First Posted: 2019-02-12
• Primary Completion: 2019-10-29
• Study Completion: 2019-10-29
• Status Verified: 2024-06
• Results First Submitted: 2024-06-21
• Results First Submitted QC: 2024-06-21
• Last Update Submitted: 2024-06-21
• Results First Posted: 2024-07-16
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PRP Treatment	Platelet Rich Plasma	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.

Primary Outcome Measures

Name	Time	Method
Prevention of Patients Requiring Surgery	6 Weeks	Number of participants that are able to avoid surgery for their perforation.

Secondary Outcome Measures

Name	Time	Method
Time to Healing	6 Weeks	Size of perforation

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States