Applying Platelet Rich Plasma (PRP) Gel to Acute Deep Partial Thickness Thermal Injuries
NCT02169362 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2017-04-13
Summary
The study will examine the safety of using a concentration of proteins from a patient's own blood, referred to as platelet rich plasma or (PRP) and applying it to a second degree burn wound.
Conditions
- Acute Deep Partial Thickness Thermal Burns
Interventions
- DEVICE
-
Autologous Platelet Rich Plasma (PRP) Gel (Magellan® Bio-Bandage™)
Application of up to 18 mL of autologous PRP gel (Magellan® Bio-Bandage™) to the surface of an acute deep partial thickness burn wound no greater than 72 cm squared within 72 hours of the initial injury. Intervention is in addition to standard of care treatment. The PRP Bio-Bandage™ is prepared using the Magellan® System and is FDA cleared via BK030040 and BK040068.
Sponsors & Collaborators
-
Department of Health and Human Services
collaborator FED -
Arteriocyte, Inc.
lead INDUSTRY
Principal Investigators
-
Brian Barnes, PhD · Arteriocyte, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 86 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-07-31
- Primary Completion
- 2018-01-31
- Completion
- 2018-05-31
Countries
- United States
Study Locations
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