Apligraf® is the only bioengineered, bi-layered, living cell-based technology that has FDA approval for the treatment of both venous leg ulcers and diabetic foot ulcers.
• Contains a combination of cytokines and growth factors found in human skin which are known to aid in the healing process
• FDA approved for diabetic foot ulcers and venous leg ulcers
Apligraf® is indicated for use with standard therapeutic compression for the treatment of non-infected partial- and full-thickness skin ulcers due to venous insufficiency of greater than one month duration and which have not adequately responded to conventional ulcer therapy.
Apligraf® is also indicated for use with standard diabetic foot ulcer care for the treatment of full-thickness neuropathic diabetic foot ulcers of greater than three weeks duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure.
Apligraf® is contraindicated for use on clinically infected wounds. Contraindicated in patients with known allergies to bovine collagen and with a known hypersensitivity to the components of the Apligraf® agarose shipping medium.
Do not open and use Apligraf® after the expiration date or if the pH is not within the acceptable range (6.8-7.7) as determined by the manufacturer provided pH color chart.
Allergic reactions to the components in the Apligraf® agarose shipping medium and bovine collagen, (a component of Apligraf®), have been reported. Discontinue product use if a patient shows evidence of an immunologic reaction. Patients should notify their physician of any symptoms of an allergic reaction. In clinical studies evaluating over 1,000 patients, no allergic reactions were reported.
Do not use Apligraf® if there is evidence of container damage or product contamination.
Apligraf® should not be reused, frozen or sterilized after opening.
Apligraf® should be kept in its tray on the shipping medium in the sealed bag under controlled temperature 68°F-73°F (20°C-23°C) until ready for use.
Apligraf® should be handled using sterile technique and placed on a prepared wound bed within 15 minutes of opening the package.
Do not use cytotoxic agents, including Dakin's Solution, Mafenide Acetate, Scarlet Red Dressing, Tincoban, Zinc Sulfate, Povidoneiodine solution, or Chlorhexidine with Apligraf®. In in vitro and in vivo histology studies, exposure to these agents degraded Apligraf®.
Device exposure to Mafenide Acetate, Polymyxin/Nystatin or Dakin's Solution also reduced Apligraf® cell viability.
Diagnosis of wound infection may be complicated by the white or yellow appearance of Apligraf® after it becomes hydrated with wound fluid. Apligraf®-treated wounds with respect to signs of suspected infection, including a change from baseline at the ulcer site for pain, edema, erythema, drainage, odor, warmth and/or unexplained fever, should be evaluated and treated according to standard practice for infection.
The persistence of Apligraf® cells on the wound and the safety of this device in venous ulcer patients beyond one year and in diabetic foot ulcer patients beyond 6 months has not been evaluated.
Testing to date has not revealed a tumorigenic potential of the cells contained in the device. However, the long term potential of skin cancers from these cells is unknown.
Although the cells and Apligraf® have been tested for multiple pathogens and are processed under aseptic conditions, all living tissue may transmit infectious agents.
The safety and the effectiveness of Apligraf® have not been established for patients receiving greater than 5 device applications.
|Shelf life greater than 2 years|
|Shelf life limited|
|Indicated for acute wounds|
|Indicated for chronic wounds|
|Indicated for diabetic ulcers||●|
|Indicated for pressure ulcers|
|Indicated for surgical wounds|
|Indicated for third-degree burns|
|Indicated for venous ulcers||●|
|Contact manufacturer for usage guidelines|
|Variety of sizes|
|Educational Material Available||●|
|Free Samples/Trials Available|
|Published Clinical Article Available||●|
Check expiration date. If expired, do not open or use. Check product pH. If not 6.8-7.7 by the provided pH chart, do not open or use.
Apligraf® should be kept in its polyethylene bag at controlled temperature 68°F-73°F (20°C-23°C) until immediately prior to use. Cut open the sealed polyethylene bag and transfer the plastic tray to the sterile field with aseptic technique. Apligraf® should always be handled aseptically.
Lift off the tray lid and note epidermal and dermal layer orientation: Apligraf® is packaged with the epidermal (dull, matte finish) layer facing up and the dermal (glossy) layer facing down, resting on the polycarbonate membrane.
Using a sterile atraumatic instrument, gently dislodge approximately (1/2)" of Apligraf® away from the wall of the tray. There should be no evidence of contamination, visible particulates or pungent odor. When lifting Apligraf®, be careful not to perforate or lift the polycarbonate membrane beneath Apligraf®. The polycarbonate membrane should remain in the tray.
With sterile gloved hands, insert one index finger under the released section of Apligraf®. Use the other index finger to grasp the Apligraf® in a second spot along the edge of the device. Holding the Apligraf® in two places lift the entire Apligraf® out of the tray using a smooth, even motion. This easy motion should prevent Apligraf® from bending and folding over onto itself. To minimize Apligraf® damage, avoid Apligraf® contact with foreign bodies and minimize handling Apligraf® except by its margins. Do not allow Apligraf® to fold or wrinkle on itself. If excessive folding occurs, Apligraf® can be floated (epidermal surface up) onto warm sterile saline solution in a sterile tray.
Apligraf® should be placed so that the dermal layer (the glossy layer closest to the medium) is in direct contact with the wound surface. Using a saline moistened cotton applicator, smooth Apligraf® onto the wound bed so there are no pockets or wrinkled edges. If there is excessive Apligraf®, which is not in contact with the wound bed, it should be trimmed away or it may adhere to the dressing.
Venous Leg Ulcers: Secure Apligraf® with a three-layer dressing so as to assure contact to wound bed. Apply a non-adherent dressing over the ulcer and Apligraf®, extending (1/2)" beyond the ulcer perimeter and inflamed skin margins. Apply a non-occlusive dressing such as fine mesh gauze. This may be folded or rolled as a bolster. Apply a self adherent elastic wrap from metatarsals to tibial plateau so that therapeutic compression is applied to the ulcer site.
The wound should be inspected and the dressing changed at least once a week during the immediate post application period. More frequent changes may be required on highly exudative wounds. Additional applications of Apligraf® may be necessary. Prior to additional applications, non-adherent remnants of Apligraf® should be gently removed. Healing tissue or adherent Apligraf® should not be disrupted. The wound bed should be cleansed with a non-cytotoxic solution prior to additional applications of Apligraf®. Additional applications of Apligraf® should not be applied over areas where Apligraf® is adherent. The wound site should continue to be dressed with a non-adherent dressing, pressure bolster and elastic overwrap as described above. Upon complete wound closure, patients should be continued with compression therapy such as support stockings. The safety and the effectiveness of Apligraf® have not been established for patients receiving greater than five device applications.
Diabetic Foot Ulcers: Apligraf® should be dressed with non-adherent saline moistened dressing, a layer of dry gauze, a layer of petrolatum gauze and gauze wrap.
The wound should be inspected and the dressing in contact with Apligraf® should be changed once a week. Outer dressings may be changed more frequently (daily). Additional applications of Apligraf® may be necessary. Prior to additional applications, non-adherent remnants of Apligraf® should be gently removed. Additional saucerized debridement may be needed to remove non-viable tissue. Healing tissue or adherent Apligraf® should not be disrupted. The wound bed should be cleansed with a non-cytotoxic solution prior to additional applications of Apligraf®. Additional applications of Apligraf® should not be applied over areas where Apligraf® is adherent. The wound site should continue to be dressed as described. After healing patients should continue to wear appropriate pressure relieving footwear and utilize other ulcer preventive footcare practices. The safety and the effectiveness of Apligraf® have not been established for patients receiving greater than five device applications.
Organogenesis Inc. is a global leader in regenerative medicine, offering a portfolio of bioactive and acellular biomaterials products for advanced wound care, orthopedics, and spine. Organogenesis' portfolio is designed to treat a variety of patients with repair and regenerative needs.