Please refer to the Apligraf Package Insert for complete prescribing information and contraindications.Wound Preparation
- Apligraf should be applied to a clean, noninfected, and debrided wound
- The wound should be thoroughly irrigated with a noncytotoxic solution
- VLUs bleed easily, so it is important to achieve hemostasis following debridement
- Before opening the Apligraf package, check the expiration date and pH to ensure it is within range
- Apligraf is packaged with the epidermal (matte) side facing up and the dermal (glossy) side facing down
- The dermal side rests on a polycarbonate membrane; be sure not to inadvertently remove it with Apligraf
- Open the package and remove Apligraf using aseptic techniques:
- Gently remove by lifting from the edge
- Apligraf must be used within 15 minutes of opening
- Apligraf may be placed on a saline soaked gauze and/or fenestrated to allow for drainage prior to application
- Place Apligraf over the wound with the dermal (glossy) side directly in contact with the wound surface
- Using a saline-moistened cotton tip applicator, smooth Apligraf onto the wound bed so there are no pockets or wrinkled edges
- Cover Apligraf using a nonadhesive primary dressing
- Anchor Apligraf using clinician's choice of fixation
- Apply a secondary nonocclusive dressing to create a bolster
- Apply appropriate compression
- Apligraf should always be used in conjunction with compression therapy and good wound care practices
- After the initial Apligraf application, the wound should be inspected weekly
- Good wound care practices, including debridement, dressing changes, and compression should be continued
- Debridement should be performed as to not disrupt healing tissue. Clean the wound with a noncytotoxic solution
- Apligraf may be reapplied weekly until the VLU has healeda
- Apply dressings and appropriate compression therapy, as shown previously
- The safety and effectiveness of Apligraf have not been established for patients receiving greater than 5 device applications. In the pivotal trial, patients received up to 5 applications over 3 weeks. The average number of applications per VLU patient was 3.3. (1. Apligraf [package insert]. Canton, MA: Organogenesis Inc.; 2017/ 2. Data on file. Organogenesis Inc).
Apligraf is supplied as a circular disk approximately 75 mm in diameter and 0.75 mm thick.
Apligraf has been processed under aseptic conditions and should be handled observing sterile technique. It should be kept in its tray on the medium in the sealed bag under controlled temperature 68°F-73°F (20°C-23°C) until ready for use.
Apligraf is supplied as a living, bi-layered skin substitute manufactured from cells processed under aseptic conditions using neonatal foreskin-derived keratinocytes and fibroblasts with bovine Type I collagen.
Apligraf is contraindicated for use on clinically infected wounds and in patients with known allergies to bovine collagen or hypersensitivity to the components of the shipping medium.
If the expiration date or product pH (6.8-7.7) is not within the acceptable range DO NOT OPEN AND DO NOT USE the product. A clinical determination of wound infection should be made based on all of the signs and symptoms of infection.
All reported adverse events, which occurred at an incidence of greater than 1% in the clinical studies are listed in Table 1, Table 2, and Table 3 of the Apligraf package insert. These tables list adverse events both attributed and not attributed to treatment.