Dermagraft® is an FDA-approved, a bioengineered human fibroblast-derived dermal substitute for the healing of diabetic foot ulcers.
• Provides metabolically active fibroblasts seeded on a bioabsorbable scaffold that produce many of the same proteins and growth factors that support the healing response in healthy skin: human collagen, extracellular matrix (ECM) proteins and cytokines and growth factors
• Helps restore the compromised wound bed and heal diabetic foot ulcers
• Proven to heal more diabetic foot ulcers faster in a randomized controlled trial and in real-world observational studies
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.
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 (dimethylsulfoxide) and bovine serum. Skin and eye contact with this packaging solution should be avoided. Dermagraft® has not been studied in patients receiving greater than eight 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. Please refer to the Dermagraft® Directions for Use for additional information.
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 refer to the Dermagraft® Directions for Use for additional information.
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. Please refer to the Dermagraft® Directions for Use for additional information.
|Assigned HCPCS code||●|
|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|
|Educational Material Available||●|
|Free Samples/Trials Available|
|Published Clinical Article Available||●|
Diabetic Foot Ulcers
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. Please refer to the Dermagraft® Directions for Use for additional information.
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 two 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 one minute. Allow Dermagraft® to thaw for two minutes. Dermagraft® should not thaw for longer than three 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 four times (for five seconds each) with saline solution. Please refer to the Dermagraft® Directions for Use for additional information.
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®.
5. Cover the wound with a non-adherent dressing. Fill, but do not pack, the wound with a dressing that provides a moist wound environment. Please refer to the Dermagraft® Directions for Use for additional information.
Not made with natural rubber latex
Organogenesis is a global leader in advanced wound care, offering a comprehensive portfolio of regenerative medicine products capable of supporting patients from early in the wound healing process through to wound closure, regardless of wound type.