Indications for Use
ActiGraft® System (RD2 System) is intended to be used at point-of-care for the safe and rapid preparation of Whole Blood Clot (WBC) gel from a small sample of a patient’s own peripheral blood. Under the supervision of a healthcare professional, the WBC gel produced by ActiGraft is topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers, diabetic ulcers, and mechanically or surgically-debrided wounds.
Important Safety Information
ActiGraft was not verified to be compatible with other wound care products. Assure the patient monthly blood draw is below 250ml per month. Throughout the processing and application of ActiGraft System, use universal precautions as defined by the facility policy and procedure manual. All parts of the procedure shall be performed in such a manner as to minimize splashing, spattering, and generation of potential droplets of blood. The ActiGraft System includes blood-contacting components that have been sterilized by Ethylene Oxide, which may cause serious allergic reactions in patients that are sensitized. Failure to follow instructions may lead to suboptimal outcomes or product failure. Outcomes may vary.
Use of the System
The ActiGraft should be used in conjunction with standard of care procedures for comprehensive wound management such as:
• Removal of necrotic or infected tissue
• Off-loading
• Compression therapy for venous stasis ulcers
• Establishment of adequate blood circulation
• Management of wound infection
• Wound cleansing
• Nutritional support, blood glucose control for subjects with diabetic ulcers
• Bowel/bladder care for subjects with pressure ulcers at risk for contamination
• Management of underlying disease
Contraindications
The ActiGraft is contraindicated in patients with the following types of wounds:
• Wounds due to malignancy
• Wounds with active clinically diagnosed infection
Precautions
• Some blood-contacting components of the ActiGraft have been sterilized by Ethylene Oxide, which can cause serious allergic reactions in some sensitized individuals.
• Throughout the processing and application of ActiGraft, use universal precautions as defined by the facility policy and procedure manual. All parts of the procedure shall be performed in such a manner as to minimize splashing, spattering, and generation of potential droplets.
• Calcium gluconate should only be used with ActiGraft system.
• Calcium gluconate (Preservative Free): Use only if solution is clear and seal intact.
• Calcium Gluconate Note: Supersaturated solutions are prone to precipitation. The precipitate, if present, may be dissolved by warming the vial to 60C to 80C, with occasional agitation, until the solution becomes clear. Shake vigorously. Allow to cool to room temperature before dispensing. Use Calcium Gluconate only if clear immediately prior to use.
• If a patient complaint on increase in pain in the days following ActiGraft application, even if the clot is complete and intact, consider to remove the clot to expose the wound and explore for possible infection in the wound or in the near area.