• Point-of-care
• Safe and rapid preparation of platelet-rich plasma (PRP) gel
• Autologous
• 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
• Septicemia
• 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.