Amnion Wound Covering for Enhanced Wound Healing

Extensive burns and full thickness skin wounds can be devastating to patients, even when
treated with our current standard of care. There are an estimated 500,000 burns treated in
the United States each year. Moreover, in the military environment, soldiers who suffer from
extensive burn injuries on the battlefield may benefit from rapid treatments that result in
complete closure and protection of the wounds. As such, there is a need for mobile platform
technologies that allow fast treatment at the site where the injury occurred, or at the very
least at the forward operating sites. This safety investigation of a human amnion membrane
powder product for wound healing is a with-in patient-controlled study, enrolling 10 subjects
undergoing donor skin graft harvest. The single-center study will include patients undergoing
donor skin harvest such that two regions, of at least 25 cm2 and separated by at least a 5 cm
gap, of donor site wounds in comparable skin locations, are available for covering with the
amnion membrane product and the current institutional standard of care (SOC) covering. The
proposed sterilized product is composed of lyophilized, gamma-irradiated powder made from
amniotic membrane for topical application with the purpose of enhanced wound healing.

The primary objective of the study is to evaluate the safety of a human amnion membrane
product intended for enhanced wound healing. The secondary objective is efficacy as evidenced
by complete wound closure relative to standard of care (SOC) treatment in a similar wound on
the same subject at donor sites created for skin grafts at 14 days and 28 days
postoperatively.

Inclusion Criteria:

- The subject requires autologous primary skin graft with two donor sites in similar
areas, each measuring at least 25 cm2 with the likely depth of 0.012 inches and
separated by a 5 cm gap. It is preferable that the two sites be on right and left
sides of the body, but it is not an exclusion if they must be on the same side.

- Eligible primary wound sites may be traumatic or chronic, and will be at least 50 cm2
(that will receive the donor graft) to allow assessment of two separate experimental
donor sites of 25 cm2.

- The subject is between the ages of 18 and 85 years of age.

- The subject is willing to complete all follow-up evaluations required by the study
protocol.

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

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

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

- The subject is able and willing to follow the protocol requirements

Exclusion Criteria:

- The subject's primary wound site is less than 50 cm2The subject's primary wound site
is not deemed appropriate for skin graft based upon the investigator's clinical
experience

- The subject has a microbiologically proven pre-existing local or systemic bacterial
infection.

- The subject has been receiving a systemic antibiotic for more than 48 hours prior to
grafting.

- Unstable cardiac disorders within the past 6 months including angina, abnormal ECG,
history of cardiac arrest, surgery and/or other interventional procedure.

- Hepatic disease or altered liver function as defined by ALT or AST value >3 times the
upper limit of normal and/or T. Bilirubin >1.5 mg/dL at screening

- Renal disease or altered renal function as defined by serum creatinine > 2 mg/dL at
screening, or end-stage renal disease.

- Hemoglobin <10.0 or >19.0 g/dL

- Known coagulopathy or platelet disorder, or INR > 1.6 , PTT > 38 sec; PLT < 50,000 at
screening

- The subject is known to have a pre-existing, chronic condition that, in the opinion of
the Investigator, may interfere with wound healing including but not limited to:
current malignancy, uncontrolled diabetes (HbA1c >8) or diabetic ulcers, autoimmune
disease or other immunocompromised diseases, renal impairment or ESRD, liver disease,
hematological