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Autologous platelet rich fibrin matrix will release growth factors which could increase the production of dermal proteins or affect the vascularity and status of neighboring tissues. This study is designed to evaluate the histologic and biochemical effect of injection of platelet rich fibrin matrix into the skin.
Subjects will be treated with platelet rich fibrin matrix into the skin of the inner aspect of the upper arm. Injected areas will be monitored clinically and will also undergo biopsies between 30 minutes and 12 weeks after treatment. Specimen of treated areas will undergo histologic and biochemical analysis and comparison to standard laboratory control specimen of untreated skin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a period from 30 minutes to 12 weeks after treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet rich fibrin matrix | Biological | Single treatment with platelet rich fibrin matrix |
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| Measure | Description | Time Frame |
|---|---|---|
| Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 30 Minutes After Treatment With Platelet Rich Fibrin Matrix | Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 30 minutes after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment. | 30 minutes after treatment |
| Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 1 Week After Treatment With Platelet Rich Fibrin Matrix | Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 1 week after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment. | 1 week after treatment |
| Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 2 Weeks After Treatment With Platelet Rich Fibrin Matrix | Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 2 weeks after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment. | 2 weeks after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony P Sclafani, MD | The NY Eye & Ear Infirmary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The NY Eye & Ear Infirmary | New York | New York | 10003 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22006233 | Result | Sclafani AP, McCormick SA. Induction of dermal collagenesis, angiogenesis, and adipogenesis in human skin by injection of platelet-rich fibrin matrix. Arch Facial Plast Surg. 2012 Mar-Apr;14(2):132-6. doi: 10.1001/archfacial.2011.784. Epub 2011 Oct 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a 12 week period. Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a 12 week period. Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 30 Minutes After Treatment With Platelet Rich Fibrin Matrix | Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 30 minutes after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment. | Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 30 minutes after treatment. | Posted | Number | %specimen with >25%new collagen/HPF | 30 minutes after treatment | skin biopsy specimen | Participants |
|
3 months
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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 | Treatment | Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a 12 week period. Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anthony Sclafani, MD | NYEEI Department of Otolaryngology | 212-979-4200 | asclafani@nyee.edu |
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| Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 6 Weeks After Treatment With Platelet Rich Fibrin Matrix |
Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 6 weeks after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment. |
| 6 weeks after treatment |
| Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 10 Weeks After Treatment With Platelet Rich Fibrin Matrix | Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 10 weeks after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment. | 10 weeks after treatment |
| Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 12 Weeks After Treatment With Platelet Rich Fibrin Matrix | Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 12 weeks after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment. | 12 weeks after treatment |
| Qualitative Changes in Dermal and Sub Dermal Vascularity 30 Minutes After Treatment With Platelet Rich Fibrin Matrix | Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 30 minutes after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment. | 30 minutes after treatment |
| Qualitative Changes in Dermal and Sub Dermal Vascularity 1 Week After Treatment With Platelet Rich Fibrin Matrix | Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 1 week after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment. | 1 week after treatment |
| Qualitative Changes in Dermal and Sub Dermal Vascularity 2 Weeks After Treatment With Platelet Rich Fibrin Matrix | Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 2 weeks after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment. | 2 weeks after treatment |
| Qualitative Changes in Dermal and Sub Dermal Vascularity 6 Weeks After Treatment With Platelet Rich Fibrin Matrix | Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 6 weeks after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment. | 6 weeks after treatment |
| Qualitative Changes in Dermal and Sub Dermal Vascularity 10 Weeks After Treatment With Platelet Rich Fibrin Matrix | Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 10 weeks after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment. | 10 weeks after treatment |
| Qualitative Changes in Dermal and Sub Dermal Vascularity 12 Weeks After Treatment With Platelet Rich Fibrin Matrix | Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 12 weeks after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment. | 12 weeks after treatment |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a period from 30 minutes to 12 weeks after treatment.
Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix
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| Primary | Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 1 Week After Treatment With Platelet Rich Fibrin Matrix | Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 1 week after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment. | Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 1 week after treatment. | Posted | Number | %specimen with >25%new collagen/HPF | 1 week after treatment | Skin biopsy specimen | Participants |
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| Primary | Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 2 Weeks After Treatment With Platelet Rich Fibrin Matrix | Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 2 weeks after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment. | Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 2 weeks after treatment. | Posted | Number | %specimen with >25%new collagen/HPF | 2 weeks after treatment | skin biopsy specimen | Participants |
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| Primary | Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 6 Weeks After Treatment With Platelet Rich Fibrin Matrix | Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 6 weeks after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment. | Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 6 weeks after treatment. | Posted | Number | %specimen with >25%new collagen/HPF | 6 weeks after treatment | Skin biopsy specimen | Participants |
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| Primary | Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 10 Weeks After Treatment With Platelet Rich Fibrin Matrix | Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 10 weeks after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment. | Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 10 weeks after treatment. | Posted | Number | %specimen with >25%new collagen/HPF | 10 weeks after treatment |
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| Primary | Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 12 Weeks After Treatment With Platelet Rich Fibrin Matrix | Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 12 weeks after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment. | Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 12 weeks after treatment. | Posted | Number | %specimen with >25%new collagen/HPF | 12 weeks after treatment |
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| Primary | Qualitative Changes in Dermal and Sub Dermal Vascularity 30 Minutes After Treatment With Platelet Rich Fibrin Matrix | Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 30 minutes after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment. | Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 30 minutes. | Posted | Number | % spec.with>5 immature capillaries/HPF | 30 minutes after treatment | Skin biopsy specimen | Participants |
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| Primary | Qualitative Changes in Dermal and Sub Dermal Vascularity 1 Week After Treatment With Platelet Rich Fibrin Matrix | Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 1 week after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment. | Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 1 week. | Posted | Number | % spec.with>5 immature capillaries/HPF | 1 week after treatment |
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| Primary | Qualitative Changes in Dermal and Sub Dermal Vascularity 2 Weeks After Treatment With Platelet Rich Fibrin Matrix | Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 2 weeks after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment. | Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 2 weeks. | Posted | Number | % spec.with>5 immature capillaries/HPF | 2 weeks after treatment |
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| Primary | Qualitative Changes in Dermal and Sub Dermal Vascularity 6 Weeks After Treatment With Platelet Rich Fibrin Matrix | Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 6 weeks after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment. | Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 6 weeks. | Posted | Number | % spec.with>5 immature capillaries/HPF | 6 weeks after treatment |
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| Primary | Qualitative Changes in Dermal and Sub Dermal Vascularity 10 Weeks After Treatment With Platelet Rich Fibrin Matrix | Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 10 weeks after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment. | Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 10 weeks. | Posted | Number | % spec.with>5 immature capillaries/HPF | 10 weeks after treatment |
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| Primary | Qualitative Changes in Dermal and Sub Dermal Vascularity 12 Weeks After Treatment With Platelet Rich Fibrin Matrix | Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 12 weeks after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment. | Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 12 weeks. | Posted | Number | % spec.with>5 immature capillaries/HPF | 12 weeks after treatment |
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