NCT02169362

Applying Platelet Rich Plasma (PRP) Gel to Acute Deep Partial Thickness Thermal Injuries

Phase I, Double-Blind, Randomized, Controlled Study to Demonstrate the Safety of Applying Autologous Platelet Rich Plasma (PRP) Gel (Magellan® Bio-Bandage™) to Acute Deep Partial Thickness Thermal Injuries

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Arteriocyte, Inc. · Industry
• Sex: All
• Age: 18 Years – 86 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The objective of this trial is to demonstrate the safety of applying autologous PRP gel (Magellan® Bio-Bandage™) to acute deep partial thickness thermal burns in the first days after burn injury. The Magellan® Bio-Bandage™ Burn Wound Care Kit is intended for the preparation and application of an autologous biological covering to deep partial thickness burn wounds to delay or minimize skin grafting requirements.

Conditions

• Acute Deep Partial Thickness Thermal Burns

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-07-01
• Primary completion: 2018-01-01
• Completion: 2018-05-01
• First posted: 2014-06-23
• Last updated: 2017-04-13

Locations

8 sites across 1 country: United States