ReCell® Combined With Meshed Skin Graft in the Treatment of Acute Burn Injuries



Status:Active, not recruiting
Conditions:Other Indications, Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:5 - Any
Updated:6/9/2016
Start Date:January 2015
End Date:January 2017

Use our guide to learn which trials are right for you!

Demonstration of the Safety and Effectiveness of ReCell® Combined With Meshed Skin Graft for Reduction of Donor Area in the Treatment of Acute Burn Injuries

This is a randomized, within-subject controlled study to compare the clinical performance of
the ReCell device when used as an adjunct to meshed skin graft in subjects requiring skin
grafts for closure of burn injuries. Co-primary effectiveness endpoints include: (1)
confirmed treatment area closure (i.e., healing) prior to or at 8 weeks as assessed by a
blinded evaluator, and (2) a comparison of the actual expansion ratio, computed as the ratio
of measured treated area to the measured donor site area, achieved for the ReCell-treated
and control treatment areas. Safety will be evaluated in terms of long-term durability, scar
outcomes and treatment-related adverse events.


Inclusion Criteria:

1. The subject requires skin grafting as a result of an acute thermal burn injury (i.e.
injuries caused by exposure of the skin to fire/flames, excessive heat, hot steam or
water).

2. The area of total burn injury is 5-50% TBSA inclusive.

3. Two areas requiring skin grafting, each at least 300cm2 (or 600cm2 contiguous),
excluding hand/face and joints.

4. The subject is at least 5 years of age.

5. The subject (or family, for those under 18 years of age) is willing and able to
complete all followup evaluations required by the study protocol.

6. The subject is to abstain from any other treatment of the wound(s) for the duration
of the study unless medically necessary.

7. The subject agrees to abstain from enrollment in any other interventional clinical
trial for the duration of the study.

8. The subject and/or guardian are able to read and understand instructions and give
informed, voluntary, written consent.

Exclusion Criteria:

1. The subject's burn injuries were caused by chemicals, electricity, and/or radioactive
substances.

2. The subject is unable to follow the protocol.

3. The subject has other concurrent conditions that in the opinion of the investigator
may compromise patient safety or study objectives.

4. The subject has a known hypersensitivity to trypsin or compound sodium lactate for
irrigation (Hartmann's) solution.

5. Life expectancy is less than 1 year.
We found this trial at
7
sites
?
mi
from
Memphis, TN
Click here to add this to my saved trials
1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Fort Sam Houston, Texas 78234
?
mi
from
Fort Sam Houston, TX
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Washington, District of Columbia
?
mi
from
Washington,
Click here to add this to my saved trials
Winston-Salem, North Carolina 27157
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials