The purpose of this research study is to find our if human amnion membrane powder can be safely used as a covering for wounds and can improve the condition of skin graft donor sites. The amnion powder product is composed of "lyophilized" (freeze-dried), "gamma irradiation sterilized" (exposed to bacteria killing radiation) fragments of amniotic membrane.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
This sterilized product is composed of lyophilized, gamma-irradiated powder made from amniotic membrane for topical application with the purpose of enhanced wound healing.
Institutional standard of care wound covering.
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Incidence of Donor Site Wound Closure
Wound closure for both amnion membrane product and SOC will be defined as skin re-epithelization without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart.
Time frame: Week 4
Incidence of Donor Site Wound Healing
Wound Healing for both amnion membrane product and SOC will be assessed clinically confirmed at two consecutive study visits 2 weeks apart.
Time frame: week 12
Presence of infection
The presence of infection will be evaluated in accordance with guidelines derived from Cutting and Harding using standard clinical measures.
Time frame: up to 26 Weeks
Vancouver Scar Assessment Scale
Scar formation will be evaluated the Vancouver Scar Assessment Scale.The scale is composed by the following Sub scales (minimum and maximum ranges in parenthesis): Pigmentation (0-2), Vascularity (0-3), Pliability (0-5), Height (0-3). Total score 0-13. Lower score denotes better outcomes for total range and subscales.
Time frame: up to 26 Weeks
Presence of Dermatitis
Allergic Response to Human Amnion Membrane Product Covering will be assessed clinically by the presence of dermatitis.
Time frame: Up to 26 Weeks
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