A Phase 1/2 interventional study of Platelet Rich Plasma in Tympanic Membrane Perforation, sponsored by University of Kansas Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-16.
Sponsored by University of Kansas Medical Center · Phase 1/2, Interventional, and Treatment
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.
45 studies on the registry are indexed under Tympanic Membrane Perforation; 10 are open to participants now.
This study's enrollment of 1 is below the median of 57 across 31 interventional studies indexed under Tympanic Membrane Perforation.
Browse Tympanic Membrane Perforation studies →University of Kansas Medical Center is the lead sponsor of 483 studies on the registry; 113 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Platelet Rich Plasma (PRP) is blood plasma that has been enriched with platelets.
Also known as: PRP
Prevention of Patients Requiring Surgery
Number of participants that are able to avoid surgery for their perforation.
Time frame: 6 Weeks
Time to Healing
Size of perforation
Time frame: 6 Weeks
| Milestone | PRP Treatment |
|---|---|
| Started | 1 |
| Completed | 1 |
| Not completed | 0 |
Number of participants that are able to avoid surgery for their perforation.
No measurements were reported for this outcome.
Size of perforation
No measurements were reported for this outcome.
Collected over 6 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PRP Treatment | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
0 participants reported because only 1 participant was enrolled and therefore confidentiality is an issue.
| Age, Categorical | PRP Treatment |
|---|---|
| <=18 years | — |
| Between 18 and 65 years | — |
| >=65 years | — |
| Age, Continuous | PRP Treatment |
|---|
| Sex: Female, Male | PRP Treatment |
|---|---|
| Female | — |
| Male | — |
| Race (NIH/OMB) | PRP Treatment |
|---|---|
| American Indian or Alaska Native | — |
| Asian | — |
| Native Hawaiian or Other Pacific Islander | — |
| Black or African American | — |
| White | — |
| More than one race | — |
| Unknown or Not Reported | — |
| Region of Enrollment(participants) | PRP Treatment |
|---|
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This study is terminated, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Tympanic Membrane Perforation→
University of Kansas Medical Center