• Open tissue architecture optimal for cell infiltration and host tissue remodeling
• Aseptic processing preserves tissue's natural structure
• Ready right out of the package
• Does not require rehydration
• Available in multiple sizes
• Shelf life of three years at ambient temperature
• Flexible, thin sheet conforms to anatomy and maintains surface contact
AlloPatch® Pliable is processed to remove cells while maintaining the integrity of the matrix with the intent to address the issues of the specific and nonspecific inflammatory responses. AlloPatch® Pliable is used as a wound care scaffold for the replacement of damaged or inadequate integumental tissue such as diabetic foot ulcers, venous leg ulcers, pressure ulcers or for other homologous use.
Conditions that could potentially inhibit integration of AlloPatch® Pliable include, but are not limited to: fever, uncontrolled diabetes, pregnancy, low vascularity of surrounding tissue, local or systemic infection, mechanical trauma, poor nutrition or poor general medical condition, dehiscence and/or necrosis due to poor revascularization, inability to cooperate with and/or comprehend post-operative instructions, infected or nonvascular surgical sites.
Do not sterilize. Do not freeze. No known sensitizing agents are present in this tissue. AlloPatch® Pliable is packaged in an ethanol solution and must be rinsed in a sterile solution prior to implantation.
Care should be taken when using AlloPatch® Pliable in conjunction with electrical equipment. NOTE: No antibiotics were used during the processing of this tissue. Do not use if container seal is not intact or damaged, if container label or identifying barcode is severely damaged, not legible, or missing, if expiration date shown on container label has passed. Do not refrigerate or freeze.
Extensive medical screening procedures have been used in the selection of all tissue donors for the Musculoskeletal Transplant Foundation (MTF) (please see MTF's Donor Screening and Testing document). Transmission of infectious diseases such as HIV or hepatitis, as well as a theoretical risk of the Creutzfeldt-Jakob (CJD) agent, may occur in spite of careful donor selection and serological testing.
Possible adverse effects of using human tissues include but are not limited to: local or systemic infection, dehiscence and/or necrosis due to poor revascularization, specific or nonspecific immune response to graft.
Store at ambient temperature. Do not refrigerate or freeze.
Moderate/Highly Exudating Wounds
Non/Minimally Exudating Wounds
AlloPatch® Pliable is packaged in a sterilized foil pouch that is designed to be passed directly into the sterile field. Use standard aseptic/sterile technique to open package.
1. Peel back the outer Tyvek package and pass inner foil pouch to sterile field.
2. Remove tissue from inner pouch using sterile gloves/forceps and immediately rinse by submerging completely in a sterile solution prior to implantation.
3. Once the tissue has been removed from the inner pouch, discard the pouch and packaging solution outside of the sterile field away from electrosurgical equipment.
4. Trim AlloPatch® Pliable to desired shape and size using sterile, dry scissors. Trim to dimensions appropriate for tension-free application and maximum contact with wound bed.
5. Place graft on wound ensuring as much contact as possible with prepared wound bed and ensuring no more than 0.5mm-2.0mm overlap of wound edges.
6. Anchor AlloPatch® Pliable by suturing, taping or stapling the sheet, ensuring first that graft overlaps adjacent intact skin.
7. Use an appropriate, non-adherent primary dressing and secondary dressing to maintain moist wound environment and the placement of tissue.
NOTE: Ensure the wound site has been debrided and prepared prior to graft placement.
Dressings covering AlloPatch® Pliable should be changed weekly or as needed.
Primary Dressing: AlloPatch® Pliable should be covered with a non-adherent dressing.
Secondary Dressing: AlloPatch® Pliable requires a moist wound environment. Use appropriate moisture management dressings for the wound type and treatment ideology.
To further encourage healing, patient should be appropriately offloaded following each visit as per institution's standard protocols.