RE-PIGMENTATION AFTER TREATMENT OF A FACIAL BURN WITH RECELL® ALONE

Patient Presentation

A 31-year-old female presented with an approximately 11% total burn surface area (TBSA) deep partial-thickness burn injury to the face from an unknown flammable liquid and flame (Figure A).

Treatment Regimen

This patient was treated on Day 1 with hydrotherapy debridement, placement of bacitracin and covered with Xeroform™. After 6 days of conservative treatment and wound care it was determined that the facial wounds would not heal on their own. The face was debrided intraoperatively with VERSAJET® until a healthy wound bed was confirmed. Allograft was placed to the face, and after 7 days it was decided to use RECELL for the patient’s face due to improvement of edema and demarcation of injury. Using the RECELL System, Spray-On Skin™ Cells were prepared and applied to the wound bed. The treatment site was dressed with Telfa™ Clear and Xeroform.

Clinical Outcome

On post-op Day 6, dressings were removed (Figure B). At post-op Day 9, the patient presented with 100% re-epithelization and no signs of infection or inflammation (Figure C). The patient was discharged at Day 11. The patient continued to show progressive re-pigmentation 2 months post-treatment (Figure D), and 3 months post-treatment (Figures E & F).

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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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