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

NCT03837665 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: STUDY00140843
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Tympanic Membrane Perforation

Keywords

Platelet Rich Plasma; TM perforations; Hearing loss; Hole in the eardrum

Outcome Measures

Primary Outcomes (1)

• Prevention of Patients Requiring Surgery

  Number of participants that are able to avoid surgery for their perforation.

  6 Weeks

Secondary Outcomes (1)

• Time to Healing

  6 Weeks

Study Arms (1)

PRP Treatment

EXPERIMENTAL

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

Interventions

Platelet Rich Plasma BIOLOGICAL

Platelet Rich Plasma (PRP) is blood plasma that has been enriched with platelets.

Also known as: PRP

PRP Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who meet criteria for tympanoplasty procedure
• Willing to comply with the protocol and attend all study visits
• Able to provide written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Tympanic Membrane Perforation; Hearing Loss

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Wounds and Injuries; Hearing Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Hinrich Staecker, MD, PhD
• Organization: University of Kansas Medical Center

hstaecker@kumc.edu

913-588-6701

Study Officials

• Hinrich Staecker, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: February 12, 2019
• Study Start: May 2, 2018
• Primary Completion: October 29, 2019
• Study Completion: October 29, 2019
• Last Updated: July 16, 2024
• Results First Posted: July 16, 2024

Record last verified: 2024-06

Locations

US (1)