IMPORTANT SAFETY INFORMATION
INDICATIONS FOR USE: The RECELL Autologous Cell Harvesting Device and RECELL GO Autologous Cell Harvesting Device are indicated for the treatment of thermal burn wounds and full-thickness skin defects. The RECELL Device and RECELL GO Device is used by an appropriately licensed and trained healthcare professional at the patient’s point of care to prepare autologous Spray-On Skin Cells for direct application to acute partial-thickness thermal burn wounds in patients 18 years of age and older, or application in combination with meshed autografting for acute full-thickness thermal burn wounds in pediatric and adult patients and full-thickness skin defects after traumatic avulsion (e.g., degloving) or surgical excision (e.g., necrotizing soft tissue infection) or resection (e.g., skin cancer) in patients 15 years of age and older.
CONTRAINDICATIONS: RECELL and RECELL GO are contraindicated for the treatment of: wounds clinically diagnosed as infected or with necrotic tissue present in the wound bed, patients with a known hypersensitivity to trypsin or compound sodium lactate (Hartmann’s) solution, and patients with a known hypersensitivity to anesthetics, adrenaline/epinephrine, povidone-iodine, or chlorhexidine solutions.
WARNINGS: Autologous use only. Control infections and excise all necrotic tissue on the wound bed prior to application of the meshed autograft and/or Spray-On Skin Cells. Wound beds treated with a cytotoxic agent (e.g., silver sulfadiazine) should be rinsed prior to application. Choose a donor site with no evidence of cellulitis or infection and process skin immediately. The enzyme is animal-derived and freedom from infectious agents cannot be guaranteed.
PRECAUTIONS: RECELL and RECELL GO are not intended for use without a meshed autograft for the treatment of acute full-thickness burn wounds or full-thickness skin defects. The safety and effectiveness of the device have not been established for the treatment of: full-thickness skin defects on the hands and genitalia; full-thickness burn wounds in patients younger than 28 days of age; and partial-thickness burn wounds >320 cm2, on the hands and articulating joints, or in patients with wounds totaling >20% TBSA.
INSTRUCTIONS FOR USE: Consult the Instructions for Use at avitamedical.com for complete Safety Information prior to using RECELL and RECELL GO.
References: 1) Instructions for Use. RECELL® Autologous Cell Harvesting Device. 2) 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. Published online November 12, 2011. doi:10.1016/ j.Burns.2011.03.001. 3) Navarro FA, Stoner ML, Lee HB, et al. Melanocyte repopulation in full-thickness wounds using a cell spray apparatus. J Burn Care Rehabil 2001;22:41–6. 4) Freedberg I, Tomic-Canic M, Komine M, et al. Keratins and the Keratinocyte Activation Cycle J Invest Dermatol 116:633-640, 2001.
