A 73-year-old presented with a full-thickness burn from a flame injury. This case study focuses on healing outcomes of the right lower leg and tendon, using a NovoSorb® Biodegradable Temporizing Matrix (BTM) and a 3:1 meshed split-thickness skin graft (STSG) in conjunction with RECELL treatment.
The leg was initially excised and treated with ACELL MicroMarixTM, ACell XenograftTM and irrigating, vacuum assisted closure device (VAC), achieving less than optimal results. After 38 days, with tibia and tendon exposed (Figure A), the leg was excised and covered with BTM (Figure B), dressed with Mepilex® Ag and a VAC. The BTM was vascularized and the temporal layer removed at 5 weeks post-placement (Figure E). The wound was prepared using a VERSAJETTM (Figure C) and the RECELL® System was used to prepare Spray-On SkinTM Cells. This suspension was applied over a 3:1 meshed split-thickness skin graft (STSG). The treatment site was dressed with TelfaTM Clear, Mepitel® Ag, and a VAC; with dressing changes twice weekly.
The widely meshed STSG sprayed with RECELL and placed over a vascularized BTM successfully healed a deep full-thickness wound, with exposed tibia and tendon. At 24 weeks post-RECELL treatment, the patient was ambulatory and the clinician noted no durability issues (Figure F). Pigment was mildly mismatched, had a scar, normal vascularity, and normal pliability (Figure F).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, 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.