Shield® is intact fish skin indicated for the management of chronic and acute wounds such as diabetic foot ulcer wounds, pressure ulcers, vascular ulcers, post-Moh’s surgical wounds, and draining wounds commonly treated in physician’s private offices.
The grafts contain fat, protein, elastin, glycans and other natural skin elements, and are fenestrated to allow adequate wound drainage for appropriate wound moisture at the wound bed. Shield products are integrated with a silicone contact layer to protect the wound and for added workflow efficiency.
Shield products are classified as medical devices, and consist of intact fish skin that has been processed using Kerecis’ proprietary EnviroIntact™ method. The products are not subject to the May 31, 2021, FDA 351 regulation.
Shield Spiral features perforated fenestration marks cut in a spiral pattern specially designed for easy & flexible graft tailoring to accommodate a range of wound sizes and shapes.
Shield Adhesive is intact fish skin featuring an integrated silicone contact layer and border. It provides the optimal gentle adhesive while allowing for moisture control and protection of the fish skin graft.
Shield Standard features a borderless silicone contact layer protecting the 50 mm intact fish skin. It allows for cutting the fish skin and protective silicone to easily fit inside the wound edges and prevents the product from tenting over deeper wounds
Kerecis grafts have been the subject of 60+ peer-reviewed studies — including multiple randomized controlled trials — showing faster healing rates and superior clinical outcomes for chronic wounds.
Kerecis is currently covered by Anthem BCBS, Humana and now Cigna for the treatment of DFUs. With our Kerecis Current™ tool, clinicians can instantly confirm patient eligibility through their EMR systems — no guessing, no delays.
Optimum application of biologic solutions is dependent on the right environment, including:
Timely Graft Removal. Biologics are highly active in the wound bed, so providers need to prevent the graft from getting stuck in a covering dressing, or being accidentally removed by someone on the care team.
Similarly, providers need to avoid the risk of exudate getting stuck under the graft or dressing: Diabetic Foot Ulcers (DFUs) and other lower extremity wounds may have increased exudate initially when biologic grafts are used, so ensuring the exudate doesn’t get trapped under the graft or dressing is essential for best outcomes.
Time is everything for healthcare providers. Gathering the ideal contact layer or covering dressing is not just time consuming, it can be infeasible in certain situations.
The Solution: Shield is specially designed to help address these challenges.
A protective “shield” directly on the fish skin graft helps ensure the fish skin does not get stuck in covering dressings, and allow for optimal drapability so it conforms to the wound. The contact layer on Shield Adhesive helps keep the graft in place for the initial placement, then separate from the graft and allow for removal of the silicone without pulling away the graft.
Exudate management is the cornerstone of all good wound care. A silicone without proper exudate control could trap fluids and risk pooling of exudate, infections or hematomas forming. To help reduce this risk, Shield products have specially-designed fenestration lines in the fish skin graft, and extra large pores in the silicone. This allows for maximum fish skin contact with the wound, and maximum drainage while still providing protective coverage.
All included in a single product, Shield helps to protect the wound environment while speeding up the preparation and application process, helping to ensure patients get the best possible outcome from their fish skin graft application.