A 54-year-old male sustained a 4.5% total body surface area (TBSA) flame burn to the face after a water heater exploded.
After initial debridement, the patient’s wound was treated with xenograft. Twelve days after the initial burn injury, the wound was excised and Spray-On SkinTM Cells were prepared using the RECELL System (Figures A & B). The cell suspension was applied directly over the prepared wound bed. The area was dressed with TelfaTM Clear, followed by XeroformTM.
The wound was healed by post-treatment Day 6 (Figure C). At 1 month post-treatment the patient experienced breakdown on the forehead with superimposed infection (Figure D). However, the wound showed restoration of pigmentation and close pigmentation match to surrounding skin without significant areas of hyper/hypopigmentation. Subsequent follow-ups (not pictured) showed continued improvement in restoration of pigment. The clinician noted that pliability and durability of the RECELL-treated area was similar to surrounding non-injured skin.
Indications for Use: The RECELL® Autologous Cell Harvesting Device is indicated for the treatment of acute thermal burn wounds. The RECELL device is used by an appropriately-licensed healthcare professional at the patient’s point of care to prepare autologous RES® Regenerative Epidermal Suspension 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.
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, and in patients younger than 28 days of age (neonates).
Special Patient Populations: The safety and effectiveness of RECELL have not been established for treatment of acute thermal partial-thickness burn wounds in pediatric patients younger than 18 years of age. For complete Important Safety Information, refer to Instructions For Use.