Tympanic Membrane Perforation
Conditions
Keywords
Platelet Rich Plasma, TM perforations, Hearing loss, Hole in the eardrum
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.
Interventions
BIOLOGICALPlatelet Rich Plasma
Platelet Rich Plasma (PRP) is blood plasma that has been enriched with platelets.
Sponsors
University of Kansas Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevention of Patients Requiring Surgery | 6 Weeks | Number of participants that are able to avoid surgery for their perforation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Healing | 6 Weeks | Size of perforation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Platelet Rich Plasma: Platelet Rich Plasma (PRP) is blood plasma that has been enriched with platelets. | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Prevention of Patients Requiring Surgery
Number of participants that are able to avoid surgery for their perforation.
Time frame: 6 Weeks
Population: 0 participants reported because only 1 participant was enrolled and therefore confidentiality is an issue.
Secondary
Time to Healing
Size of perforation
Time frame: 6 Weeks
Population: 0 participants reported because only 1 participant was enrolled and therefore confidentiality is an issue.