Relese™ is comprised of dehydrated human amniotic membrane obtained from donated placental tissue.
INTENDED USE: Relese™ is a sheet skin substitute product that contains non-viable cells and is intended for use as a selective barrier and to protect wounds from the surrounding environment for chronic and acute wounds including dermal ulcers and other defects.
CLAIMED BENEFITS: The processed membrane is dehydrated, fenestrated and cut into various sizes, and presented in a sterilized, dehydrated sheet graft form. The processing of Relese™ preserves all layers of the placental membrane and maintains the 3D physiologic architecture of the natural barrier membrane. This triple layer barrier containing amnion, intermediate layer, and chorion provides a selective barrier and protection between wound and the surrounding environment.
OPTION: Relese™ is offered in a variety of sizes from 2x2 cm to 6x8 cm sheets. The amount of Relese™ used will be determined by the treating health care provider, based on the size of the wound. Relese™ can be applied over the wound area either wet or dry. If hydration is preferred, sterile solution is used to hydrate the graft after placement on the wound site. Relese™ is supplied as a terminally sterilized dehydrated human tissue allograft derived from human amnion and chorion membrane. Relese™ should be maintained in its original packaging and stored at ambient temperature (0°C to 38°C) until ready to use. Relese™ is for single patient use only.
The addition of Skin Substitutes or Cellular or Tissue Based Products (CTPs) to certain wounds may afford a healing advantage over dressings and conservative treatments when these options appear insufficient to affect complete healing, after at least a 30 day period of comprehensive conservative therapy. There are currently a wide variety of bioengineered products available for soft tissue coverage to affect closure. • Human skin allografts are derived from donated human skin (cadavers) • Allogeneic matrices are derived from human tissue (fibroblasts or membrane) • Composite matrices are derived from human keratinocytes, fibroblasts and xenogeneic collagen • Acellular matrices are derived from xenogeneic collagen or tissue
For Medicare to cover this product, it needs to be ordered and applied by your clinician. A patient cannot purchase it directly from a Durable Medical Equipment (DME) store and receive reimbursement for it.
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