Evaluation of the Mechanism of Action of Platelet Rich Fibrin Matrix (PRFM) in Producing Skin Volume Augmentation
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of the Mechanism of Action of Platelet Rich Fibrin Matrix (PRFM) in Producing Skin Volume Augmentation|
- Changes in dermal and subdermal protein content after treatment with platelet rich fibrin matrix compared to control specimen [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Changes in local skin blood flow after treatment with platelet rich fibrin matrix [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Study Completion Date:||July 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a 12 week period.
Biological: Platelet rich fibrin matrix
Single treatment with platelet rich fibrin matrix
Other Name: Selphyl
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 over a 12 week period. Specimen of treated and control areas will undergo histologic and biochemical analysis and comparison.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00956020
|United States, New York|
|The NY Eye & Ear Infirmary|
|New York, New York, United States, 10003|
|Principal Investigator:||Anthony P Sclafani, MD||The NY Eye & Ear Infirmary|