Salera® is an aseptically processed, dehydrated human amnion and chorion allograft for use as an acute or chronic wound covering.
• Maintains inherent growth factors and matrix proteins
• Aseptic processing preserves tissue's natural structure
• Ready right out of the package
• Can be used in the hydrated or dehydrated state
• Available in multiple sizes
• Shelf life of three years at ambient temperature
• Conforms to anatomy and maintains surface contact
Salera® is processed to maintain the integrity of the matrix with the intent to address the issues of the specific and non-specific inflammatory responses. Salera® is used as a wound care scaffold for the replacement of damaged or inadequate integumental tissue such as diabetic foot ulcers, venous leg ulcers, pressure ulcers, or for other homologous use. It is intended for single use only.
The presence of severe vascular compromise, active or latent infection or uncontrolled infection may compromise the usefulness of the tissue.
Do not sterilize. Prescription use only. No known sensitizing agents are present in this tissue. NOTE: No antibiotics were used in the processing of this tissue.
Do not use if container seal is not intact or damaged, if container label or identifying barcode is severely damaged, not legible or missing or if expiration date shown on container label has passed.
Salera® should be stored at ambient temperature. Do not refrigerate or freeze. It is the responsibility of the transplant facility or clinician to maintain the tissue intended for transplantation in the appropriate recommended storage conditions prior to transplant.
Extensive medical screening procedures have been used in the selection of all tissue donors for the Musculoskeletal Transplant Foundation (MTF) (please see MTF's Donor Screening and Testing document). Transmission of infectious diseases such as HIV or hepatitis, as well as a theoretical risk of the Creutzfeldt-Jakob (CJD) agent, may occur in spite of careful donor selection and serological testing.
Possible adverse effects of using human tissues include but are not limited to: infection of soft tissue and/or bone (osteomyelitis), fever, disease transmission and undesirable immune response.
Store at ambient temperature. Do not refrigerate or freeze.
|Assigned HCPCS code||●|
|Shelf life greater than 2 years||●|
|Shelf life limited|
|Indicated for acute wounds||●|
|Indicated for chronic wounds||●|
|Indicated for diabetic ulcers||●|
|Indicated for pressure ulcers||●|
|Indicated for surgical wounds||●|
|Indicated for third-degree burns|
|Indicated for venous ulcers||●|
|Contact manufacturer for usage guidelines|
|Educational Material Available||●|
|Free Samples/Trials Available||●|
|Published Clinical Article Available||●|
Moderate/Highly Exudating Wounds
Non/Minimally Exudating Wounds
Salera® is packaged in a sterilized foil pouch that is designed to be passed directly into the sterile field. Use standard aseptic/sterile technique to open package.
1. Prepare wound area using standard methods to ensure wound is free of debris and necrotic tissue.
2. Peel open chevron seal of outer Tyvek pouch and pass inner foil pouch to sterile field.
3. Peel open chevron seal of inner pouch and remove tissue from inner pouch using sterile gloves/forceps.
4. In a dry state, use sterile dry scissors to trim Salera® to fit dimensions of application site. It is recommended no more than 0.5mm-2mm overlap over the wound margin.
5. Apply Salera® directly to patient site. If needed, membrane may be hydrated with sterile saline.
6. Anchor Salera® with tissue adhesives or by suturing the sheet, ensuring first that graft overlaps adjacent intact skin.
7. Use appropriate, non-adherent, primary dressing and secondary dressing to maintain a moist wound environment and the placement of the tissue.
NOTE: Ensure wound site is free of debris and necrotic tissue. Debride if necessary prior to graft placement. NOTE: Once foil pouch is opened, tissue should be used promptly. The opened innermost pouch alone is not intended for storage of tissue, as it may not provide an adequate moisture or sterile barrier.
Salera®'s inner bottle and the outer foil pouch are sterilized. Use standard aseptic/sterile technique to open the package and make it ready for use.
Peel open the foil pouch and transfer the inner bottle as a single unit into the sterile field. Remove the white cap and aluminum collar from the bottle. Remove the rubber stopper. Note: The container should be held firmly on a hard surface while removing stopper to prevent spillage. Apply Salera® directly to the patient site. If needed, the tissue may be hydrated with sterile saline prior to or after application.
Note: Ensure the wound site is free of debris and necrotic tissue and debride if necessary prior to graft placement. Once the foil pouch is opened, tissue should be used promptly. Innermost bottle alone is not intended for storage of tissue, as it may not provide an adequate moisture or sterile barrier.
Note: The tissue must be implanted or discarded within 24 hours of opening the tissue container, provided the allograft tissue is maintained in an aseptic environment.
Dressings covering Salera® should be changed weekly or as needed.
Primary Dressing: Salera® should be covered with a non-adherent dressing.
Secondary Dressing: Salera® requires a moist wound environment. Use appropriate moisture management dressings for the wound type and treatment ideology.
To further encourage healing, patient should be appropriately offloaded following each visit as per institution's standard protocols.
MTF Biologics Wound Care is a division of MTF Biologics, a leading non-profit tissue bank. The Wound Care division is dedicated to developing highly advanced, safe, clinically-based and cost-effective wound care solutions that work in concert with the body's natural healing process.