Effective healing and the formation of robust skin requires the presence and products of keratinocytes, fibroblasts and melanocytes1,2
RECELL provides a cellular suspension of three phenotypes: keratinocytes, fibroblasts and melanocytes.7
These isolated single cells stimulate healing throughout the wound bed rather than being limited to the wound edge.7
Singer AJ, Clark RAF. Cutaneous wound healing. New England Journal of Medicine. 1999; 341(10):738-746.
Pastar I, Stojadinovic O, Yin NC, Ramirez H, Nusbaum AG, Sawaya A, Patel SB, Khalid L, Isseroff RR, Tomic-Canic M. Epithelialization in wound healing: A comprehensive review. Advances in Wound Care. 2014; 3(7):445-464.
Komine et al. The activated keratinocytes. Acta dermatovenerologica APA Vol 4, 95, No 4: 169-173.
Freedberg et al. Keratins and the Keratinocyte Activation Cycle. The Society for Investigative Dermatology. 2001; 116(5):633-640.
Pastar I. Epithelialization in Wound Healing: A Comprehensive Review. Advances in Wound Care. 2014; 3(7):445-464.
Trim JT, Quick A. The use of RECELL® and Regenerative Epithelial Suspension™ in Effective Treatment of Skin Injuries and Defects. Journal of Wound Technology. 2015; 27:20-24.
Wood FM, Giles N, Stevenson A, Rea S, Fear M. Characterisation of the cell suspension harvested from the dermal-epidermal junction using a RECELL® kit. Burns. 2012; 38(1):44-51.
Indications for Use: The RECELL® Autologous Cell Harvesting Device is indicated for the treatment of acute thermal burn wounds in patients 18 years of age and older. The RECELL® device is used by an appropriately-licensed healthcare professional at the patient’s point of care to prepare autologous Regenerative Epidermal Suspension (RES™) for direct application to acute partial-thickness thermal burn wounds or application in combination with meshed autografting for acute full-thickness thermal burn wounds.
Contraindications: RECELL® is contraindicated for: the treatment of wounds clinically diagnosed as infected or with necrotic tissue, the treatment of patients with a known hypersensitivity to trypsin or compound sodium lactate (Hartmann’s) solution, patients having a known hypersensitivity to anesthetics, adrenaline/epinephrine, povidone-iodine, or chlorhexidine solutions.
Warnings: Autologous use only. Wound beds treated with a cytotoxic agent (e.g., silver sulfadiazine) should be rinsed prior to application of the cell suspension. RECELL® is provided sterile and is intended for single-use. Do not use if packaging is damaged or expired. Choose a donor site with no evidence of cellulitis or infection and process skin immediately. A skin sample should require between 15 and 30 minutes contact with Enzyme. Contact in excess of 60 minutes is not recommended. RECELL® Enzyme is animal derived and freedom from infectious agents cannot be guaranteed.
Precautions: RECELL® is not intended for use without meshed autograft for treatment of full-thickness burn wounds. The safety and effectiveness of RECELL® without meshed autograft have not been established for treatment of partial-thickness burn wounds: on the hands and articulating joints, >320 cm2, in patients with wounds totaling >20% total body surface area (TBSA). The safety and effectiveness of RECELL® with autografting have not been established for treatment of full-thickness burn wounds: on the hands and articulated joints, in patients with wounds totaling >50% TBSA.
Special Patient Populations: The safety and effectiveness of RECELL® have not been established for treatment of acute thermal partial-thickness or full-thickness burn wounds in pediatric patients younger than 18 years of age. For complete Important Safety Information, refer to Instructions For Use.