TruSkin™ is a cryopreserved skin allograft, and retains an extracellular matrix, rich supply of endogenous growth factors and living skin cells. Serves as an alternative to fresh skin grafts.
• Durable skin substitute for larger wounds
TruSkin™ is limited to use as a skin allograft and may be used to repair acute or chronic skin wounds of various sizes, including but not limited to diabetic foot ulcers, venous leg ulcers, pressure ulcers, dehisced surgical wounds, traumatic burns, and radiation burns. TruSkin™ may be used over exposed bone, tendon, joint capsule and muscle.
TruSkin™ should not be used in a wound suspected of having an acute or chronic infection.
1. Intended for use in one patient, on a single occasion only.
2. Do not use if package integrity has been compromised. Once the user breaks the container seal, the tissue grafts must be transplanted or discarded.
3. Tissue may not be sterilized or re-sterilized.
4. Tissue is intended for use by qualified healthcare specialists such as physicians, podiatrists, or other appropriate healthcare professionals.
5. The same medical/surgical conditions or complications that apply to any surgical procedure may occur during or following application.
6. The physician is responsible for informing the patient of the risks associated with his/her treatment and the possibility of complications and/or adverse reactions.
7. Caution should be exercised for patients with known sensitivities to the following reagents used for processing, disinfection, and storage that may remain on the product:
• Disinfection and Processing: Skin tissue may have been disinfected and processed with Kanamycin Sulfate and/or Cephazolin and/or Gentamicin Sulfate, chlorhexidine, and alcohol, RPMI w/L-Glutamine no phenol red, and traces may remain.
• Cryopreservation: Residual levels of gentamicin sulfate and cefazolin, been cryopreserved with a 6-10% (v/v) glycerol solution and does remain on tissue.
• Note: The graft is processed without Beta-lactam antibiotics.
Donor screening methods are limited; therefore, certain diseases may not be detected. The following complications of tissue transplantation may occur:
•Transmission of diseases of unknown etiology;
•Transmission of known infectious agents including, but not limited to, viruses, bacteria, and fungi;
•Immune rejection of implanted HCT/P; or
•Loss of function and/or integrity of HCT/P due to resorption, fragmentation, and/or disintegration.
Please promptly report possible adverse event outcomes to Community Tissue Services at 800.684.7783.
Can be stored at or below -40°C, but not in liquid nitrogen.
Processed from donated human cadaveric skin, subsequent from the generous gift of an individual or his/her family.
Residual levels of gentamicin sulfate and cefazolin have been cryopreserved with a 6-10% (v/v) glycerol solution and does remain on tissue.
1. Sinclair SM, Blackmore M, Kuang JQ, Sathyamoorthy M, Liu Y, Moriello M, Gooden F, Hunter S, and Danilkovitch A. Development of a Novel Viable Cryopreserved Skin Allograft (vCSA) [Poster]. Presented at Desert Foot 2015; November 2015; Phoenix, AZ, USA.
2. Sinclair SM, Sathyamoorthy M, Moriello M, Liu Y, Kuang JQ, Blackmore M, Gooden F, Hunter S, and Danilkovitch A. Characterization of a Novel Viable Cryopreserved Skin Allograft (vCSA) [Poster]. Presented at Desert Foot 2015; November 2015; Phoenix, AZ, USA.
|Indicated for chronic vascular ulcers||●|
|Indicated for diabetic ulcers||●|
|Indicated for draining wounds|
|Indicated for partial- and full-thickness wounds||●|
|Indicated for pressure ulcers||●|
|Indicated for surgical wounds||●|
|Indicated for third-degree burns||●|
|Indicated for trauma wounds||●|
|Indicated for venous ulcers||●|
|Variety of sizes||●|
|Educational Material Available||●|
|Free Samples/Trials Available|
|Published Clinical Article Available|
Moderate/Highly Exudating Wounds
Non/Minimally Exudating Wounds
TruSkin™ can be applied in an office or hospital outpatient setting, or in an operating room.
Change weekly at the discretion of the responsible physician for the duration of treatment.
Non-adherent dressing and outer dressings
Packaged within two plastic containers under aseptic conditions. The inside of the outer peel pack and the inner pouch that contains the allograft are sterile. The outside of the outer pouch is not sterile.
Donor eligibility is determined based on FDA screening and testing criteria, which includes testing for the following:
HIV-1 NAT: Human Immunodeficiency Virus Type 1 Nucleic Acid Test
HBsAg: Hepatitis B Surface Antigen
Anti-HBcAb: Hepatitis B Total Core Antibody
HCV NAT: Hepatitis C Virus Nucleic Acid Test
Anti-HCV: Hepatitis C Virus
Treponema pallidum (Syphilis)
Osiris Therapeutics, Inc. is a leader in researching and developing regenerative medicine products that improve lives. Osiris has achieved commercial success with products in orthopaedics, sports medicine and wound care.