RegenKit®-Wound Gel-1 and RegenKit®-Wound Gel-2 are cutting-edge medical device kits designed for advanced wound care. RegenKit®-Wound Gel-1 contains one PRP tube and one ATS (Autologous Thrombin Serum) tube to prepare approximately 6.5 mL of autologous RegenWound® Gel. RegenKit®-Wound Gel-2, ideal for larger wound areas, includes two PRP tubes and one ATS tube to produce approximately 13 mL of RegenWound® Gel.

Both kits utilize pharmaceutical-grade vacuum tubes to collect and process blood efficiently, isolating and concentrating growth factors, functional platelets, and plasma proteins while eliminating iron-laden red blood cells. This process yields a nutrient-rich autologous wound gel, optimized for purity, recovery, and sustained delivery of healing factors directly to the wound bed.

RegenKit®-Wound Gel-1 and RegenKit®-Wound Gel-2 are designed for the safe and efficient preparation of autologous platelet-rich plasma (PRP) gels directly at the point of care. The resulting RegenWound® Gel can be topically applied under the supervision of a healthcare professional to manage exuding cutaneous wounds, including chronic diabetic ulcers, pressure ulcers, leg ulcers, and mechanically or surgically debrided wounds.

RegenKit®-Wound Gel-1 and RegenKit®-Wound Gel-2 are single-use devices intended for the rapid preparation of PRP gels at the patient’s bedside to enhance wound healing through re-epithelialization, revascularization, and granulation tissue formation.

RegenKit®-Wound Gel-1 Includes:

• 1 RegenWound® PRP 10 mL Tube
• 1 RegenWound® ATS Tube
• 1 Safety-Lok™ Butterfly Needle
• 1 Collection Holder
• 1 Transfer Device
• 1 Transfer Needle
• 1 5 mL Luer-Lok™ Syringe

RegenKit®-Wound Gel-2 Includes:

• 2 RegenWound® PRP 10 mL Tubes
• 1 RegenWound® ATS Tube
• 1 Safety-Lok™ Butterfly Needle
• 1 Collection Holder
• 1 Transfer Device
• 1 Transfer Needle
• 1 5 mL Luer-Lok™ Syringe

Designed to support high-volume wound care settings, both kits offer a premium wound-healing solution with minimal preparation time and maximum ease of use.

Key Features:

• Concentrated Platelets: Direct delivery of live, functional platelets and growth factors to the wound bed.
• Flexible Fibrin Matrix: A manipulable gel adaptable to any wound shape, ensuring sustained release of healing factors.
• Safe and Effective: Fully autologous preparation with PRP naturally activated using the patient’s own thrombin serum.
• Rapid Preparation: Requires a simple 20 mL (Wound Gel-1) or 30 mL (Wound Gel-2) blood draw, followed by a single 5-minute centrifuge spin and 10-minute setting time.

RegenKit®-Wound Gel-1 and RegenKit®-Wound Gel-2 must be used following strict aseptic technique. Avoid cross-contamination, improper centrifuge usage, or using components past their expiration date. These kits are for single-use only. Follow all manufacturer instructions for centrifugation and ensure proper safety precautions during blood collection and handling. Use proper safety precautions to avoid contact with patient blood or cross-contamination. Use proper safety precautions to protect against needles or broken tubes. Do not use sterile component of this kit if it is opened or damaged. Do not use components of this kit if they are broken or present a defect. Do not use the tube if it has lost vacuum. Do not use the sodium citrate solution or other tube components separately. Store between 5 ºC and 30ºC; bring the kit to ambient temperature before using tubes. Do not re-sterilise, do not use after the expiration date. Single use device, do not reuse any part of the kit. Reuse may lead to infection or other illness / injury. Transfer needle must be used to transfer liquids only and should not be used for injection. The preparation of the platelet-rich plasma (PRP) must be performed by a physician trained on the equipment and procedure, or under the supervision of the physician. The treatment with PRP must be performed by a qualified physician. Do not inject PRP intravascularly. The patient must be informed of the general risks associated with the treatment and of the possible adverse effects. The safety and effectiveness of combination of PRP with other therapies should be assessed by the physician. The safety and effectiveness have not been evaluated in children and in pregnant or lactating women. The PRP must be prepared from fresh blood and must be used within four hours (extemporaneous use only).

All tubes and components of the kit are to be entirely discarded by elimination method after each use to avoid potential contamination with blood products. Use a 45° fixed angle rotor centrifuge or a horizontal head swinging bucket centrifuge (ex. RegenPRP Centri provided by Regen Lab). Follow the manufacturer’s instructions when using the centrifuge. Tubes should be centrifuged, as recommended in the instructions for use, at a relative centrifugation force (RCF) of 1500 g. Excessive RCF (over 2200 g) may lead to tube breakage resulting in blood exposure, and possible injury. RCF below 1500 g may lead to incorrect blood separation and red blood cell contamination of PRP. Centrifuge carriers and inserts size should be adapted to the tubes. Use of carriers too large or too small may result in breakage of the tubes. Caution should be taken to ensure that tubes are properly seated in the centrifuge carriers. Tubes must be balanced in the centrifuge.

Possible adverse effects:

Possible side effects of blood collection
Blood collection may cause damage of the blood vessels, hematomas, superficial phlebitis, delayed wound healing, early or late infection and/or temporary or permanent nerve damage that may result in pain or numbness.