Wound Healing (United States)

Indications for use:

The RECELL Autologous Cell Harvesting Device is indicated for the treatment of thermal burn wounds and full-thickness skin defects. The RECELL Device is used by an appropriately licensed and trained healthcare professional at the patient’s point of care to prepare autologous Spray-On Skin Cells for direct application to acute partial-thickness thermal burn wounds in patients 18 years of age and older, or application in combination with meshed autografting for acute full-thickness thermal burn wounds in pediatric and adult patients and full-thickness skin defects after traumatic avulsion (e.g., degloving) or surgical excision (e.g., necrotizing soft tissue infection) or resection (e.g., skin cancer) in patients 15 years of age and older.

Contradictions:

The RECELL Autologous Cell Harvesting Device is indicated for the treatment of thermal burn wounds and full-thickness skin defects. The RECELL Device is used by an appropriately licensed and trained healthcare professional at the patient’s point of care to prepare autologous Spray-On Skin Cells for direct application to acute partial-thickness thermal burn wounds in patients 18 years of age and older, or application in combination with meshed autografting for acute full-thickness thermal burn wounds in pediatric and adult patients and full-thickness skin defects after traumatic avulsion (e.g., degloving) or surgical excision (e.g., necrotizing soft tissue infection) or resection (e.g., skin cancer) in patients 15 years of age and older.

RECELL is contraindicated for the treatment of wounds clinically diagnosed as infected or with necrotic tissue present in the wound bed. RECELL is contraindicated for: 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. Control infections on wounds prior to application of the cell suspension. Excise the necrotic tissues on wound bed prior to application of the cell suspension. 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:

Autologous use only. Control infections on wounds prior to application of the cell suspension. Excise the necrotic tissues on wound bed prior to application of the cell suspension. 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.

Special Patient Populations:

Instructions for use:

Consult the Instructions for Use prior to using RECELL. For complete Important Safety Information, refer to Instructions for Use.

Repigmentation (United States)

Indications for use:

The RECELL Autologous Cell Harvesting Device is indicated for repigmentation of stable depigmented vitiligo lesions in patients 18 years of age and older. The RECELL Device is intended for use by an appropriately licensed and trained healthcare professional at the patient’s point-of-care for the safe and rapid preparation of Spray-On Skin Cells from a small sample of a patient’s own skin. The suspension of Spray-On Skin Cells is suitable for application to skin resurfaced by an ablative laser. A portion of the suspension of Spray-On Skin Cells may also be applied to the donor site.

Contradictions:

RECELL is contraindicated for the treatment of patients with a known hypersensitivity to trypsin or compound sodium lactate solution (Hartmann’s Solution). The skin sample collection procedure specified for use of RECELL should not be used with patients having a known hypersensitivity to anesthetics, adrenaline/epinephrine, povidone-iodine, or chlorhexidine solutions.

Warnings:

Autologous use only. RECELL is provided to the healthcare professional sterile and is intended for single use. Do not reuse, freeze, or re-sterilize device components. Handle using aseptic technique. Do not use RECELL or device components if packaging is damaged or there are signs of tampering. Do not use RECELL or device components beyond the stated expiration date indicated on the adhesive Lot # and Expiration Date labels on the outer box packaging. Choose a healthy skin sample donor site that shows no evidence of lack of pigmentation or surrounding cellulitis or infection. For optimum cell viability, the skin sample should be processed immediately after harvesting. Do not use silver sulfadiazine or other cytotoxic agents on the ablative laser prepared RECELL treatment areas. If a skin sample is harvested and processed according to these instructions, it should require between 15 and 30 minutes of contact with the Enzyme. Contact in excess of 60 minutes is not recommended. The Enzyme is derived from animal tissue and, although strict controls have been implemented in the manufacturing process to minimize the risk of pathogen contamination, a small risk of contamination exists and absolute freedom from infectious agents cannot be guaranteed. Contaminated materials and waste must be disposed of using appropriate biohazard waste receptacles.

Precautions:

The safety and effectiveness of RECELL has not been established for repigmentation of: vitiligo lesions appearing on lips, eyelids, plantar surface of feet, or palmar surface of hands; vitiligo lesions with recent history (within 12 months) of Koebnerization, confetti-like or trichrome appearance; and patients with a history of keloid formation.

Instructions for use:

Consult the Instructions for Use prior to using RECELL. For complete Important Safety Information, refer to Instructions for Use.

Outside of the United States

Indications for use:

RECELL is indicated for harvesting of skin cells from a patient’s split-thickness skin samples, for reintroduction to the patient. For specific indications please see the Instructions for Use for the appropriate country.

Contradictions:

RECELL is contraindicated for treatment of infected wounds or with necrotic tissue present in the wound bed or with necrotic tissue present in the wound bed, and for patients having unstable vitiligo or a known hypersensitivity to anesthetics, adrenaline/epinephrine, povidine-iodine, or chlorhexidine solutions.

Warnings and precautions:

Regenerative Epidermal Suspension (RES™ ) prepared using the RECELL Device should only be applied to patients from whom the original skin sample was taken. RECELL is provided sterile and is intended for single-use. Do not use if packaging is damaged or expired. A skin sample should require between 15 and 30 minutes contact with the Enzyme. Contact in excess of 60 minutes is not recommended. RECELL Enzyme is animal derived and freedom from infectious agents cannot be guaranteed. RES™ should be applied to a clean, dry, haemostatic vascularized wound bed.

For complete Important Safety Information refer to Instructions For Use for specific countries.

Adverse reactions:

Any adverse reaction or suspected adverse reaction related to RECELL should immediately be reported to AVITA Medical.

Our portfolio is marketed under the RECELL® brand to promote skin healing in a wide range of applications including burns, chronic wounds, and aesthetics.