Using Autologous Platelet Rich Plasma (PRP) Gel to Treat Deep 2nd and 3rd Degree Burns
|ClinicalTrials.gov Identifier: NCT01843686|
Recruitment Status : Active, not recruiting
First Posted : May 1, 2013
Last Update Posted : January 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Burns||Device: Magellan® Other: Placebo Saline Gel and Usual and Customary Standard of Care||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Investigator)|
|Official Title:||Use of Autologous Platelet Rich Plasma (PRP) Gel as an Adjunct to the Treatment of Deep 2nd and 3rd Degree Burns|
|Actual Study Start Date :||April 2013|
|Estimated Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||March 2018|
Experimental: Autologous Platelet Rich Plasma (PRP)
Magellan Autologous Platelet Separator used to extract Platelet Rich Plasma from autologous whole blood. PRP is mixed with calcified thrombin to create a gel, which is place on the excised wound bed prior to application of split thickness autograft.
Autologous Platelet Rich Plasma Prepared Using the Magellan System
Other Name: Autologous Platelet Rich Plasma
Placebo Comparator: Saline Gel, Standard of Care
Normlgel Saline is placed on the excised wound bed prior to application of split thickness autograft.
Other: Placebo Saline Gel and Usual and Customary Standard of Care
- Demonstrate the safety of application of autologous platelet rich plasma (PRP) gel following excision of an acute deep 2nd and 3rd degree burn. [ Time Frame: 12 Months ]Examine that there is no increase in adverse events above what is seen with excision and split thickness autografting of deep 2nd and 3rd degree burns
- Assessment of a composite of wound healing measurements [ Time Frame: 12 Months ]
This treatment is intended to stimulate rapid healing and improve outcomes of standard of care burn treatments:
- Time to 100% healing and time to complete wound closure (skin re-epithelialization without drainage or dressing requirements conﬁrmed at study visits wound remained closed for at least 14 days)
- Length of hospital stay
- Time for return to full activity clinical wound measurement with respect to wound surface area and need for reoperation.
- Monitoring improvement of scar appearance.
- Assessment of wound flora, dermal collagen and elastin content, and epithelialization using tissue markers.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01843686
|United States, California|
|University of California, Davis, Division of Burn Surgery|
|Sacramento, California, United States, 95817|
|United States, District of Columbia|
|Medstar Health Research Institute|
|Washington, District of Columbia, United States, 20010|
|United States, Utah|
|University of Utah Hospital|
|Salt Lake City, Utah, United States, 84132|
|Study Director:||Brian R. Barnes, PhD||Arteriocyte, Inc.|