The safety and effectiveness of RECELL has been studied in two multi-center randomized controlled clinical trials consisting of 131 patients with deep partial-thickness (DPT) to full-thickness (FT) burns1,2,3.
Significant Reduction in Donor Site Size
Significant size comparison may be visualized below. RECELL donor site for a DPT Burn is on the left. STSG to treat a DPT Burn is on the right.
Incidence of Donor Site Healing
Twice as fast with RECELL at week one2
Superior Donor Site Scar Outcomes
Reduced scarring was reported with RECELL vs 2:1 meshed STSG for all time points2
Comparable incidence of definitive closure in both DPT2 and FT burns.3
Plot shows incidence of definitive closure for standard of care 2:1 meshed STSG in comparison to RECELL in DPT burns with 52 week follow-up (N=101).
Plot shows incidence of definitive closure for standard of care meshed STSG in comparison to a more widely meshed STSG+RECELL for the treatment of mixed-depth burns (inclusive of FT) with a 52 week follow-up (N=30)
Reduced Patient-Reported Donor Site Pain
was improved by greater than 50% through Week 8
Plot shows reduced patient reported pain levels associated with the RECELL donor sites vs donor sites associated with 2:1 meshed STSGs (control) (N=101)
Low incidence of adverse events (AEs) were reported, with no unanticipated events reported for the study population. Within the clinical trials, most AEs were mild and resolved with conservative intervention. Long-term durable healing was achieved for both the RECELL-treated and Control-treated burn wounds.
STSG: split-thickness skin graft; TBSA: total body surface area; VAS: visual analog scale
Instructions for Use. RECELL® Autologous Cell Harvesting Device
Holmes JH, et al. A comparative study of the RECELL® device and autologous split-thickness meshed skin graft in the treatment of acute burn injuries. J Burn Care Res. 2018;39(5):694-702.
Pivotal Study 2: Standard of care meshed STSG vs RECELL applied in combination with a more widely meshed STSG than standard of care for the treatment of mixed-depth burns (inclusive of FT) with a 52-week follow-up (N=30)
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 Regenerative Epidermal Suspension (RES™) 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.