Epidermal Coverage of Traumatic Wound Injuries Via Use of Autologous Spray Skin Applied Over Bilayered Wound Matrix

The goal of the study described herein is to determine the safety, tolerability, preliminary
and long-term effectiveness of the use of the Recell device over a widened STSG mesh. It is
hypothesized the ReCell cell suspension, in combination with INTEGRA™ MBWM, will improve upon
the current standard of care. The potential for ReCell's promotion of healing in the
interstices of the STSG mesh may close gaps that are potential points of failure during
subsequent rehabilitation and return to physical activity. Within the current study, each
participant will serve as his/her own control, allowing for comparison of ReCell treated
(experimental) and non-ReCell treated (control) regions of the grafted wound. In the proposed
study, each patient will serve as his/her own control. Due to the nature of the study, only
patients whose wounds have been previously successfully treated with INTEGRA™ MBWM as part of
their standard of care will qualify for participation.

Therefore, as part of enrollment eligibility criteria for this study, the identified study
wound will first be treated with INTEGRA™ MBWM. The wound will then be allowed to heal for
approximately two to four weeks, at which time a viable granulation layer will have developed
thus allowing for next stage STSG grafting. The timing of the STSG application will be
determined by clinician judgment based on the state of the granulation process, which varies
between patients, but typically takes 2 to 4 weeks.

Approximately two to four weeks after INTEGRA™ MBWM treatment, the studied wound will be
divided into a ReCell-treated area (over 1:5 meshed STSG) and a control area treated with
1:1.5 meshed STSG (no ReCell). In all cases, the ReCell region may be up to 320cm2 in size;
the upper limit of application area for one ReCell kit, with a similarly sized control
region. If the wound is larger than the combined ReCell and control regions (over 640cm2),
the areas outside the study regions will be designated as non-study areas and treated
according to standard of care. The same primary and secondary dressings will be used on
ReCell-treated areas, control areas and donor sites. Once the study and control wounds are
determined to have healed, standard local clinical practice will be followed.

Within-subject comparisons of the ReCell region and control region, in order to evaluate
improvements associated with use of ReCell, a battery of measurements and evaluations will be
made. These measurements are divided into three categories: safety and tolerability,
preliminary effectiveness (acute healing process) and long-term effectiveness.

The safety of research participants is foremost. Therefore, efforts will be made to control
risks to participants throughout the duration of their study participation. Wound healing
time, donor site morbidity and histology will be assessed during an acute 6 week phase, with
follow-up visits at Weeks 1, 2, 3, 4 and 6 post-treatment.

Subjects will continue in the study for long-term follow-up with clinic visits at Week 12 and
24 post-treatment. Healing of treated wound sites (A region and B region) and donor sites
(STSG 1:5, STSG 1:1.5 and ReCell) will be assessed at each visit. Treated wounds will be
considered healed when 95% or greater of the study area has re-epithelialized by Week 6
post-treatment. Donor sites will be considered healed when ≥95% of the donor site has
re-epithelialized by Week 4 post-treatment. Aesthetic and functional outcomes of the treated
areas will be assessed and documented. Subject satisfaction will also be assessed and
documented at these two time points.

Inclusion Criteria:

- • The subject is a male or female military healthcare beneficiary of any race or
ethnicity, aged 18 years or older, who is being treated for a traumatic wound at
WRNMMC

- The subject has soft tissue loss resulting from a traumatic mechanism such as an
explosive blast (i.e. motar, rocket, IED), high-velocity shells (i.e. missile),
an avulsion injury, gunshot wound motor vehicle accident and/or burn secondary to
blast

- The subject's full-thickness or deep partial-thickness traumatic wound injury has
been treated with INTEGRA™ MBWM as part of their standard of care

- The wound area is at least 200 cm2

- All areas of the study wound area are covered with INTEGRA™ MBWM and has fully
engrafted - engrafting defined as the presence of a contiguous vascularized
granulation layer indicated by the formation of a viable granulation layer (Note:
there may be some areas of incomplete granulation at the INTEGRA™ MBWM
application site, these areas will be excluded from the study wound area).

- The subject will comply with protocol requirements

- The subject will provide voluntary written informed consent and Health Insurance
Portability and Accountability Act (HIPAA) authorization

Exclusion Criteria:

- Subjects will not be eligible for study participation if they meet any of the
following criteria:

- The subject is pregnant and/or lactating (self-reported)

- The subject has evidence of the following lab value results:

1. Hematocrit ≤ 20%

2. INR > 1.8 second

3. Creatinine (serum) > 2.0 mg/dL

4. Bilirubin Total (serum) within upper limit of normal (normal range 0.3-1.9
md/dL

5. Liver function test (AST/ALT) greater than 2 times upper limit of normal as
defined by the clinical laboratory defined normal ranges

6. Albumin (serum) < 2.0 g/dL

7. Platelets < 70 K/µL

- The subject's targeted traumatic wound injury is a craniofacial wound

- The subject's targeted traumatic wound injury is on a weight-bearing surface

- The subject's targeted traumatic wound is a full-thickness burn injury with
visible eschar present (Note: Subjects with a traumatic wound of a burn nature
secondary to an explosive blast injury resulting in significant soft tissue loss
will NOT be excluded)

- The subject has active infection processes, that in the opinion of the
investigator may compromise safety or study objectives

- The subject is known to have a pre-existing condition that may interfere with
wound healing, e.g. malignancy, diabetes or autoimmune disease, immunocompromised
blood borne diseases, has AIDS, is HIV or Hepatitis-A positive, or currently has
a severe dermatological disorder (e.g. severe psoriasis, epidermolysis bullosa,
pyoderma gangrenosum)

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

- The subject has a known hypersensitivity to Trypsin and/or Compound Sodium
Lactate for Irrigation (Hartmann's) solution

- The subject cannot be compliant with study procedures and that, in the
investigator's opinion, would interfere with the study objectives