Wound and Burn Dressing
Summary of Regulatory Approval Pathways
- Class III Device
- Combination Product
- Product Code: MGR
1). Integra Dermal Regeneration Template: P900033 (a device to treat the skin of people with severe burns)
INTEGRA® Dermal Regeneration Template is a device to treat the skin of people with severe burns. FDA has recently expanded the approved use of this device. I INTEGRA® may now be used to treat the often disabling scars that result from severe burns.
INTEGRA® has two layers. The bottom layer (dermal) is made of a fibrous protein material (collagen) from cows and a substance made from shark cartilage. The top layer (epidermal) is made of silicone
When INTEGRA® is placed on a wound where the burned skin or scarred tissue has been removed, it allows blood vessels and other cells to grow a new layer of skin while the collagen is absorbed into the body. The silicone layer helps close the wound and prevent fluid loss. After approximately 14 to 21 days, the silicone layer is removed, and a very thin graft of the patient’s own skin (autograft) is applied to the wound area.
INTEGRA® is indicated for use on:
- Patients with severe burns where there is a limited amount of their own skin to use for autografts or they are too ill to have more wound sites created
- Patients undergoing reconstructive surgery for burn scars where there is a limited amount of their own skin to use for autografts or they are too ill to have more wound sites created.
2). APLIGRAF: P950032
Expedited processing eras authorized on May 30 1995 based on the potential of Apligraf to provide a clinically important advance over existing alternatives in the treatment of chronic venous insufficiency ulcers.
Apligraf is indicated for use with standard therapeutic compression for the treatment of non infected partial and full thickness skin ulcers due to venous insufficiency of greater than 1 month duration and which have not adequately responded to conventional ulcer therapy
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3). OrcelTM (Bilayered Cellular Matrix): P010016
Indications for Use
OrCel™ is indicated for the treatment of fresh, clean split thickness donor site wounds in burn patients.
OrCel™ is a bilayered cellular matrix in which normal human allogeneic skin cells (epidermal keratinocytes and dermal fibroblasts) are cultured in two separate layers into a Type I bovine collagen sponge. Donor dermal fibroblasts are cultured on and within the porous sponge side of the collagen matrix while keratinocytes, from the same donor, are cultured on the coated, non-porous side of the collagen matrix. OrCel™ serves as an absorbable biocompatible matrix that provides a favorable environment for host cell migration and has been shown to contain the following cell-expressed cytokines and growth factors: FGF-1 (bFGF), NGF, GM-CSF, IL-1α, IL-1β, IL-6, HGF, KGF-1 (FGF- 7), M-CSF, PDGF-AB, TGF-α, TGF-β1, TGF-β2, and VEGF. OrCel™ is not intended to be a human skin replacement and does not contain Langerhans cells, melanocytes, macrophages, lymphocytes, blood vessels or hair follicles. DNA analysis performed on two OrCel™ -treated donor site patient tissue samples showed no trace of allogeneic cell DNA after two or three weeks respectively.
OrCel™ is manufactured under aseptic conditions from human neonatal foreskin tissue. The donor’s mother is tested and found to be negative for syphilis and for human viruses,
including CMV, HSV I & II, HTLV I & II, Hepatitis B&C, HIV 1&2, EBV and HHV-6. The donor’s fibroblast and keratinocyte cells are tested and found to be negative for viruses and retroviruses (including HTLV I&II, Hepatitis B, HIV 1&2, EBV, and HHV- 6), bacteria, fungi, yeast, mycoplasma, and tumorigenicity. The donor cells are tested and are found to be normal human cells using karyology, isoenzyme, growth and morphological analyses. Prior to cell seeding, the matrix is cross-linked and then coated on one side with a thin gel layer prepared from acid-soluble collagen. The final product is tested for morphology, cell density, cell viability, sterility, mycoplasma, and physical container integrity. All animal derived reagents are tested for: viruses, bacteria, fungi, yeast, and mycoplasma before use, and all bovine material is obtained from countries free of Bovine Spongiform Encephalopathy (BSE).
The device measures approximately 6 cm x 6 cm (minimally 36 cm2 ). A non-adherent mesh is placed on both aspects of the device to protect the cells. The device is packaged in a plastic tray with protein-free packaging medium containing DMEM, water for irrigation, sodium bicarbonate, folic acid solution, HEPES buffer, L-Glutamine, MEM non-essential amino acids, and sodium hydroxide to maintain cell viability during storage and shipping.
The plastic tray is sealed within a peelable inner pouch to provide a sterile barrier against moisture and gas. The inner pouch is, in turn, sealed inside a heavier-gauge outer pouch that protects the inner pouch sterility barrier and the product against damage during shipment. The multi-stage packaged product is packed with pre-chilled gel packs and shipped to the destination in a padded and insulated shipping container that maintains a temperature of 11-18° C (for up to 72 hr.).
FDA Preclinical Review
Composite Cultured Skin (CCS) was first used in Australia on RDEB (Recessive Dystrophic Epidemolysis Bullosa) patients.
Ortec International Inc. introduced this product in the USA for the first time in their clinical studies with burn patients via G920046. Later the product was approved for several additional clinical studies: G960200 (indicated for the treatment of Epidermolysis Bullosa patients), G980037 (indicated for the treatment venous ulcer patients), G990063 (indicated for the treatment of donor sites in burn patients), G990204 (indicated for diabetic foot ulcers). Recently, the same device (OrcelTM Composite Cultured Skin has been approved for marketing under a humanitarian device exemption (HDE) for EB patients (H990013).
In addition to the clinical studies referenced above, the subject device, CCS was also approved for use in clinical studies for the indication of donor sites in burn patients. For details regarding the pilot study protocol, see G920046/S28, G920046/S29, G920046/30.
The pivotal study was conducted under the IDE, G990063.
Biocompatibility of Collagen Sponge
The following biocompatibility studies were conducted on the collagen sponge: Cytotoxicity, hemolysis, sensitization, acute systemic toxicity, subchronic toxicity, mutagenicity, rabbit pyrogen test. All tests were negative.
FDA Approval Information
Access to FDA Approval Information: OrCel Bilayered Cellular Matrix – P010016
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Last Updated: 2015-12-09
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