Please refer to the Dermagraft Directions For Use for complete prescribing information and contraindications.
Materials required for preparation and application of Dermagraft:
- Water bath/thawing tub (containing 37°C water) with lid
- Sterilized scissors
- Surgical gloves
- Clock or timer
- Sterile normal saline (0.9% sodium chloride) at room temperature
- Permanent ink marker
- Sterilized blunt-end forceps
- Rinsing stand for Dermagraft
- Dressing supplies
Prepare thawing tub with 2 liters of water at 34°C to 37°C. Tear open the foil pouch with your hands at top and remove the clear bag containing Dermagraft. Remove Dermagraft from shipper; submerge within 1 minute. Allow Dermagraft to thaw for 2 minutes. Dermagraft should not thaw for longer than 3 minutes. Remove Dermagraft from water bath. Place in rinsing stand. Cut the clear bag open above the cut line with sterilized scissors. Dermagraft should be rinsed 4 times (for 5 seconds each) with saline solution.
- Hold bag up to wound and trace the edge of the wound onto the bag.
- With sterilized scissors, carefully cut the Dermagraft from the edge of the bag along the traced lines, also creating a handling tab
- Carefully peel the plastic from both sides of Dermagraft using sterilized forceps
- Apply Dermagraft into the debrided ulcer covering surface of wound just below the epithelial layer and ensure no air is trapped under the Dermagraft
- Cover the wound with a non-adherent dressing. Fill, but do not pack, the wound with a dressing that provides a moist wound environment. See full directions for use for additional information
Dermagraft is supplied frozen in a clear bag containing one piece of approximately 2 in x 3 in (5 cm x 7.5 cm) for a single-use application.
Dermagraft must be stored continuously at -75°C ± 10°C.
Dermagraft is a cryopreserved, 3-dimensional, human dermal substitute composed of human fibroblasts, an extracellular matrix, and a bioabsorbable polyglactin mesh scaffold.
Dermagraft allows for serial applications without the need for removal of the product from the wound.1
- Dermagraft Directions for Use. Organogenesis. 2015.
Dermagraft is contraindicated for use in ulcers that have signs of clinical infection or in ulcers with sinus tracts. Dermagraft is contraindicated in patients with known hypersensitivity to bovine products as it may contain trace amounts of bovine proteins from the manufacturing medium and storage solution.
The product must remain frozen at -75°C ± 10°C continuously until ready for use. Do not use any topical agents, cytotoxic cleansing solutions, or medications (e.g., lotions, ointments, creams, or gels) on an ulcer being treated with Dermagraft as such preparations may cause reduced viability of Dermagraft. Do not reuse, refreeze, or sterilize the product or its container. Do not use the product if there is evidence of container damage or if the date and time stamped on the shipping box has expired. Dermagraft is packaged with a saline-based cryoprotectant that contains 10% DMSO (Dimethyl sulfoxide) and bovine serum. Skin and eye contact with this packaging solution should be avoided. Dermagraft has not been studied in patients receiving greater than 8 device applications. Dermagraft has not been studied in patients with wounds that extend into the tendon, muscle, joint capsule, or bone. Dermagraft has not been studied in children under the age of 18 years, in pregnant women, in patients with ulcers over a Charcot deformity of the mid-foot, or in patients receiving corticosteroids or immunosuppressive or cytotoxic agents. To ensure the delivery of metabolically active, living cells to the patient's wound, do not hold Dermagraft at room temperature for more than 30 minutes. After 30 minutes, the product should be discarded and a new piece thawed and prepared consistent with Preparation for Use instructions. The persistence of Dermagraft in the wound and the safety of this device in diabetic foot ulcer patients beyond six months has not been evaluated. Testing has not revealed a tumorigenic potential for cells contained in the device. However, the long-term response to these cells is unknown. Always thaw and rinse product according to the Preparation for Use instructions to ensure the delivery of metabolically active, living cells to the patient's wound. Do not use Dermagraft after the expiration date indicated on the labeled unit carton.
In clinical studies conducted to date, the overall incidence of reported adverse events was approximately the same for patients who received Dermagraft compared to those who received the Control treatment.