CAMPR-II RWE TRIAL: A Saline-hydrated Allogeneic Dual-layer Amniotic Membrane Product or a Synthetic, Resorbable Polymeric Wound Matrix to a Coarsened Exact Matched Retrospective Control Cohort of Hard to Heal DFUs and VLUs

IP 2: Microlyte® is a sterile, single use absorbent polymeric wound matrix composed primarily of bioresorbable polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/in2. It absorbs wound fluid and forms a soft matrix that conforms to the wound surface and maintains a moist, wound-healing environment. The matrix contains silver only to prevent or minimize microbial growth within the matrix. Microlyte® Matrix is cleared by the U.S. Food and Drug Administration (FDA) under 510(k) \[K153756\] as a Class II device for the management of partial- and full-thickness wounds, including diabetic foot ulcers, venous stasis ulcers, pressure ulcers, surgical and traumatic wounds, and first- and second-degree burns and may be used over debrided and grafted partial-thickness wounds. It is fully synthetic and cleared as an antimicrobial barrier. The product is regulated under 21 CFR 878.4020 (dressing, wound,

IP 1: Membrane Wrap - Hydro is a saline-hydrated allogeneic dual-layer amniotic membrane product that meets the criteria for regulation as a human cell, tissue, or cellular or tissue-based product (HCT/P) solely under section 361 of the Public Health Service (PHS) Act and 21 CFR part 1271. The amnion allograft is screened, processed, labeled, and distributed in a manner that prevents transmission of disease and is an allograft derived from donated human birth tissue. Membrane Wrap - Hydro amniotic membrane processing includes cleaning, rinsing, applying sterile mesh, folding to create a dual layer, drying then cutting, followed by hydration with sodium chloride solution 0.9%" and sterilization using irradiation. Membrane Wrap - Hydro™ is intended to serve "as a supportive barrier and provides protective coverage from the surrounding environment to acute and chronic wounds. Membrane Wrap-Hydro may be applied from the onset of the wound and for the duration of the wound.