An 85-year-old female presented with a 9% total burn surface area (TBSA) mixed-depth flame burn injury to the lower left arm. This case report focuses on the treatment outcomes achieved using Spray-On SkinTM Cells in combination with a 2:1 meshed split-thickness skin graft (STSG). This case report focuses on a treatment area with the RECELL System which represents an approximately 2-3% body surface area (BSA).
The mixed-depth wound was excised (Figure A). The RECELL System was used to prepare Spray-On Skin Cells which were applied over a 2:1 meshed STSG (Figure B). The wound was dressed with TelfaTM Clear, followed by XeroformTM and bulky dressings.
By week 1 post-treatment (not pictured), the RECELL-treated area was ≥ 95% healed according to the attending physician. By week 2 post- treatment (Figure C) the wound was completely re-epithelialized. At Week 24 (Figure D), the RECELL-treated area was assessed using the Patient and Observer Scar Assessment Scale (POSAS). The observer scored the pigmentation of the RECELL-treated area as a “1,” indicating the area treated with Spray-On Skin Cells had the same pigmentation as “normal skin.”See More
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 RES® Regenerative Epidermal Suspension 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, 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.