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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 antibio…