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

No results posted yet for this study

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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02169362 on ClinicalTrials.gov