A human derived composite amnion-chorion membrane (ACM, BioXclude®, Snoasis Medical, CO, USA) is a dehydrated collagenous allograft comprised of amnion and chorion layers derived from the human placenta. Human placentas were donated under informed consent as regulated by the Food and Drug Administration’s (FDA) Good Tissue Practice and American Association of Tissue Banks (AATB). All donors were tested to be free of infectious diseases, including human immunodeficiency virus (HIV), human T-cell lymphotropic virus (HTLV), Hepatitis B and C, syphilis, and Cytomegalovirus (CMV)22. The amniotic and chorionic membranes were processed using a proprietary PURION® process that involves gentle cleansing and dehydrating the membranes while preserving the structural integrity and biochemical activity of the tissue. The amniotic membrane and the chorionic membrane were either processed separately, or laminated to form a two-layer graft. The composite amnion-chorion membrane is significantly thicker (~300 μm) compared to the layered amnion alone (<100 μm). Processed ACMs are terminally sterilized by gamma irradiation, which has been proven not to affect the bioactivity of the allograft, prior to sterile packaging23. Commercially available ACMs were obtained from Snoasis Medical and used directly in this study.
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