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

Primary Purpose

Tympanic Membrane Perforation

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Platelet Rich Plasma

About this trial

This is an interventional treatment trial for Tympanic Membrane Perforation focused on measuring Platelet Rich Plasma, TM perforations, Hearing loss, Hole in the eardrum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of Kansas Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PRP Treatment

Arm 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.

Outcomes

Primary Outcome Measures

Prevention of patients requiring surgery

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

Secondary Outcome Measures

Time to healing

Size of perforation

Full Information

NCT ID

NCT03837665

First Posted

February 8, 2019

Last Updated

February 27, 2019

Sponsor

University of Kansas Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03837665

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Unknown status

Study Start Date

May 2, 2018 (Actual)

Primary Completion Date

June 30, 2019 (Anticipated)

Study Completion Date

June 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Kansas Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tympanic Membrane Perforation

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PRP Treatment

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Platelet Rich Plasma

Other Intervention Name(s)

PRP

Intervention Description

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

Primary Outcome Measure Information:

Title

Prevention of patients requiring surgery

Description

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

Time Frame

6 Weeks

Secondary Outcome Measure Information:

Title

Time to healing

Description

Size of perforation

Time Frame

6 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kevin Sykes, PhD

Phone

913-588-7154

ksykes@kumc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Bryan Humphrey

bhumphrey@kumc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hinrich Staecker, MD

Organizational Affiliation

University of Kansas Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Kansas Medical Center

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Matthew Shew, MD

First Name & Middle Initial & Last Name & Degree

Kevin Sykes, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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