Dermagraft® is a cryopreserved human fibroblast-derived dermal substitute; it is composed of fibroblasts, extracellular matrix, and a bioabsorbable scaffold.
• Composed of living, human fibroblasts, an extracellular matrix, and a bioabsorbable polyglactin mesh scaffold
• Cryopreserved three-dimensional human dermal substitute
• FDA-approved (under a PMA) to treat diabetic foot ulcers
• Can be applied weekly for up to eight applications within a 12-week period
Dermagraft® is indicated for use in the treatment of full-thickness diabetic foot ulcers greater than six weeks duration, which extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure. Dermagraft® should be used in conjunction with standard wound care regimens and in patients that have adequate blood supply to the involved foot.
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 solutions.
CAUTION: 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®.
CAUTION: 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.
CAUTION: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.
CAUTION: 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.
CAUTION: Do not reuse, refreeze, or sterilize the product or its container.
CAUTION: 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.
CAUTION: Dermagraft® is packaged with a saline-based cryoprotectant that contains 10% DMSO (Dimethylsulfoxide) and bovine serum. Skin and eye contact with this packaging solution should be avoided.
CAUTION: Do not use Dermagraft® after the expiration date indicated on the labeled unit carton.
CAUTION: The product must remain frozen at -75°C +/- 10°C continuously until ready for use.
CAUTION: Dermagraft® has not been studied in patients receiving greater than 8 device applications.
CAUTION: 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.
In the 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.
Please see the Dermagraft® Directions for Use at www.dermagraft.com.
Dermagraft® must be stored continuously at -75°C +/- 10°C. For continuous storage, the transfer of Dermagraft® from its original shipping container into an appropriate freezer must take no longer than 15 seconds to ensure cell viability.
|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||●|
In clinical studies evaluating Dermagraft® for the treatment of ulcers in diabetic patients, Dermagraft® was applied weekly for up to a total of eight applications over a 12-week period.
Diabetic foot ulcers must receive adequate sharp debridement, removing any necrotic or hyperkeratinized tissue, leaving a wound bed that meets the clinical criteria for skin grafting prior to application of Dermagraft® (i.e., clean, granulating wound bed).
If extensive bleeding is observed after sharp debridement, the bleeding must be controlled before applying Dermagraft®; no topical agents may be used to stop the bleeding.
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
PREPARATION FOR USE
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.
1. Hold bag up to wound and trace the edge of the wound onto the bag.
2. With sterilized scissors, carefully cut the Dermagraft® from the edge of the bag along the traced lines, also creating a handling tab.
3. Carefully peel the plastic from both sides of Dermagraft® using sterilized forceps.
4. Apply Dermagraft® into the debrided ulcer covering surface of wound just below the epithelial layer and ensure no air is trapped under the Dermagraft®.
Following each application of Dermagraft®, the first wound dressing change should take place in approximately 72 hours.
NOTE: If a dressing change is needed prior to 72 hours, the non-adherent dressing layer should be left in place.
Dermagraft® may be applied weekly for up to 8 applications over a 12 week period.
Cover the wound with a non-adherent dressing. Fill, but do not pack, the wound with a dressing that provides a moist wound environment.
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.