Deep Partial-Thickness Burn with RECELL Alone

Patient Presentation

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).

Treatment Regimen

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.

Clinical Outcome

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.”

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Important Safety Information

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, 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.

Important Safety Information

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...

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