AmnioBand® Membrane
AmnioBand® Membrane is an aseptically processed, dehydrated human amnion and chorion allograft for use as an acute or chronic wound covering.
Product Literature
MTF Biologics Wound Care
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.Benefits
• 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
• Flexible
• Conforms to anatomy and maintains surface contact
Indications
AmnioBand® Membrane is processed to maintain the integrity of the matrix with the intent to address the issues of the specific and non-specific inflammatory responses. AmnioBand® Membrane 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.
Contraindications
The presence of severe vascular compromise, active or latent infection or uncontrolled infection may compromise the usefulness of the tissue.
Warnings and Precautions
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.
AmnioBand® Membrane 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.
Adverse Effects/Reactions
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.
Storage Requirements
Store at ambient temperature. Do not refrigerate or freeze.
How Supplied/Sizing
2cmx2cm, 2cmx3xm, 2cmx4cm, 3cmx4cm, 3cmx8cm, 4cmx4cm, 4cmx6cm, 5cmx6cm, 7cmx7cm. Disks: 10mm, 14mm, 16mm, 18mm diameter.
Patient condition
HCPCS Code
Product features
Assigned HCPCS code
Minimally manipulated
Cryopreserved
Dehydrated
Desiccated
Flowable
Micronized
Sheet form
Requires refrigeration
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
Other features
Educational Material Available
Free Samples/Trials Available
Published Clinical Article Available
Recommended Use
Acute Wounds
Burns
Cavity Wounds
Chronic Wounds
Deep Wounds
Dehisced Wounds
Diabetic Foot
Granulating/Epithelializing Wounds
Hypertrophic Scars/Keloids
Moderate/Highly Exudating Wounds
Non/Minimally Exudating Wounds
Palliative Wounds
Pressure Ulcers
Superficial Wounds
Surgical Wounds
Traumatic Wounds
Venous Ulcers
Mode of Use/Application
AmnioBand® Membrane 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 AmnioBand® Membrane to fit dimensions of application site. It is recommended no more than 0.5mm-2mm overlap over the wound margin.
5. Apply AmnioBand® Membrane directly to patient site. If needed, membrane may be hydrated with sterile saline.
6. Anchor AmnioBand® Membrane 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.
Removal & Change Frequency
Dressings covering AmnioBand® Membrane should be changed weekly or as needed.
Additional Recommended Dressings
Primary Dressing: AmnioBand® Membrane should be covered with a non-adherent dressing.
Secondary Dressing: AmnioBand® Membrane 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.
Clinically Tested
Non-cytotoxic
Non-immunogenic
Non-irritating
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