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Recruitment barriers
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet Rich Plasma | Biological | Platelet Rich Plasma (PRP) is blood plasma that has been enriched with platelets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevention of Patients Requiring Surgery | Number of participants that are able to avoid surgery for their perforation. | 6 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Healing | Size of perforation | 6 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hinrich Staecker, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
0 participants reported because only 1 participant was enrolled and therefore confidentiality is an issue.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Prevention of Patients Requiring Surgery | Number of participants that are able to avoid surgery for their perforation. | 0 participants reported because only 1 participant was enrolled and therefore confidentiality is an issue. | Posted | 6 Weeks |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hinrich Staecker, MD, PhD | University of Kansas Medical Center | 913-588-6701 | hstaecker@kumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 7, 2018 | Sep 6, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018058 | Tympanic Membrane Perforation |
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D014947 | Wounds and Injuries |
| D006311 | Hearing Disorders |
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|
| Age, Continuous |
| Sex: Female, Male |
|
| Race (NIH/OMB) |
|
| Region of Enrollment | participants |
|
|
| Secondary | Time to Healing | Size of perforation | 0 participants reported because only 1 participant was enrolled and therefore confidentiality is an issue. | Posted | 6 Weeks |
|
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| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |