Regen Wound Gel is an autologous platelet-rich plasma gel. Topically applied to manage exuding cutaneous wounds such as leg ulcers, pressure wounds, and diabetic ulcers.
• Safe and rapid preparation of platelet-rich plasma (PRP) gel
• Small sample of a patient's own peripheral blood
RegenKit®-Wound Gel-2 is designed to be used at point-of-care for the safe and rapid preparation of platelet-rich plasma (PRP) gel (Regen Wound Gel) from a small sample of a patient's own peripheral blood. Under the supervision of a health care professional, the Regen Wound Gel is topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers and diabetic ulcers, and mechanically or surgically debrided wounds.
• Congenital and acquired disorders of platelet function and thrombocytopenia
• Hemodynamic instability
• Severe metabolic or systemic disorders
• Coronary artery disease
• Congestive heart failure
• Liver failure
• Renal failure on hemodialysis
• Active gastrointestinal bleeding
• Hemoglobin less than 10g/dl
• Platelet count less than100x109/L
• Serum albumin level less than 2.5g/dl
• Wounds with active clinically diagnosed infection
• Patient unwilling to accept known risks
• Hypersensitivity to sodium citrate anticoagulant
• Wounds due to malignancy
• Consistent use of non-steroidal anti-inflammatory drugs (NSAIDs) within 48 hours of the procedure
• Consistent use of other medication or dietary supplement(s) which alter platelet function, within 3 days of the procedure
• Corticosteroid injection at the treatment site within 1 month of the procedure
• Systemic use of corticosteroids within 2 weeks of the procedure
• Recent fever or illness
• Hematological malignancies
• Other non-hematological malignancies
There was a total of 37 adverse events (AEs) reported in 29 subjects in the clinical trial. Of these 37 AEs, four AEs were serious adverse events. Among the 33 other AEs, 11 (33.3%) occurred in the Regen Wound Gel group, while 22 (66.6%) occurred in the control group. None of the AEs were considered related to Regen Wound Gel.
Blood collection may cause damage of the blood vessels, hematomas, superficial phlebitis, early or late infection and/or temporary or permanent nerve damage that may result in pain or numbness.
The kit should be stored between 5°C-30°C (41°F-86°F). The platelet rich plasma and serum must be stored at room temperature (15°C-25°C, 59°F-77°F) and used within four hours of blood collection. Addition of calcified thrombin will change the liquid PRP to a gel consistency in about 10 minutes, depending on the proportion of serum used and the coagulation status of the patient's blood. The resulting Regen Wound Gel should be transferred to the wound bed immediately.
Within the tube- USP anticoagulant sodium citrate 4% w/v solution; Autologous Thrombin Serum- processed with the red (ATS) tube.
Needed reagents not supplied in the kit: A USP 10% injectable solution of calcium is needed to trigger the coagulation of PRP. Either calcium gluconate or calcium chloride can be used.
The materials used for platelet separator consist of medical grade polymer, and glass certified as suitable for use as medical devices. All kit components supplied with RegenKit®-Wound Gel-2 are sterile.
Moderate/Highly Exudating Wounds
Non/Minimally Exudating Wounds
Applied topically. RegenKit®-Wound Gel-2 should be used in conjunction with standard of care (SOC) procedures for
comprehensive wound management
Cover the Regen Wound gel with layers of paraffin gauze to reduce moisture loss. Fix this primary dressing with permeable dressing tape. Cover the primary dressing with a secondary dressing of sterile gauze to absorb exudates, and bandage or other means of appropriate fixation. This secondary dressing is changed as often as deemed necessary. The paraffin gauze should be in direct contact with the fibrin polymer and the wound, and should not be removed until the next treatment except in case of infection. In case of infection, the wound should be cleaned and treated for the infection before resuming PRP treatment. Repeat the treatment after one week, then the interval can be increased to 2 or 3 weeks or even more. Repeat until full closure of the wound.
As deemed necessary by provider.
Biocompatibility Testing Various studies were conducted in accordance with the FDA guidance "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". The battery of testing included the following tests: cytotoxicity, sensitization, irritation, acute systemic toxicity, hemocompatibility, and rabbit pyrogen study.
The RegenKit®-Wound Gel-2 contains 2 RegenBCT tubes and 1 Regen ATS tube. Each tube is filled with 10ml of blood (30ml of blood needed in total) to produce approximately 13ml of Regen Wound Gel for use in the treatment of wounds, such as diabetic foot ulcers, classified up to 3A according to the University of Texas Classification. The material produced may be used to treat a deep wound with wound surface area up to 5 cm².
The materials used for platelet separator consist of medical grade polymer, USP anticoagulant sodium citrate 4% w/v solution and glass certified as suitable for use as medical devices. All kit components supplied with RegenKit®-Wound Gel-2 are sterile.
RegenKit®-Wound Gel-2 is packaged in a single blister and is sterilized by exposure to a minimum dose of 25 kGy gamma irradiation.
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