- Q: Is LifeCell Corporation the only source of AlloDerm® Tissue Matrix?
A: Yes. LifeCell Corporation, of Branchburg, New Jersey, is the sole source of AlloDerm® Regenerative Tissue Matrix.
- Q: When can I expect to receive my order?
A: Normal shipping of AlloDerm® Tissue Matrix and Cymetra® Tissue Matrix is via overnight delivery. We strive to process each order within 24 hours. We will also arrange delivery based on your specific directions. LifeCell™ only ships orders on Fridays for Saturday deliveries.
- Q: What is the optimal temperature range in which to store AlloDerm® Tissue Matrix?
A: Upon receipt, AlloDerm® tissue grafts must be stored according to the required storage conditions noted on each graft. Refrigerated storage is 1C - 10C (34-50F) and AlloDerm® Ready To Use storage is at room temperature (8-30C / 18-86F). The shelf life of all AlloDerm® Tissue Matrices is two years following the date of processing.
- Q: What happens if AlloDerm® Tissue Matrix is left out of the refrigerator?
A: If AlloDerm® Tissue Matrix has been left unrefrigerated, please contact LifeCell Customer Support at 800-367-5737.
- Q: What is the shelf life of AlloDerm® Tissue Matrix?
A: AlloDerm® Tissue Matrix has an expiration date that is noted on the package label.
- Q: What is the shelf-life of Cymetra®?
A: Cymetra® Tissue Matrix has an expiration date that is noted on the package label.
- Q: Once AlloDerm® Tissue Matrix is rehydrated, how long can we keep it?
A: When fully hydrated, AlloDerm® Tissue Matrix is ready to use. The matrix may be left in the second rehydration dish for up to 4 hours.
- Q: What is the best way to determine the dermal side of AlloDerm® Tissue Matrix?
A: AlloDerm® Tissue Matrix has two distinct sides: The basement membrane
and the dermal surface.
In an implant procedure, the dermal side should rest against the most vascular tissue to speed up the revascularization process.
How to Distinguish Sides
- Physical appearance
- Basement membrane side: Rough and dull.
- Dermal side: smooth and shiny.
- Distinguishing sides using the blood test
- Add a drop of blood to both sides and rinse with rehydration solution. Since blood readily infiltrates the vascular channels within the matrix, the dermal side will look bright red. The basement membrane side will look pink.
- Q: What happens to AlloDerm® Tissue Matrix after it is grafted or implanted into the body?
A: AlloDerm® Regenerative Tissue Matrix allows for tissue regeneration by supporting rapid revascularization, white cell migration and cell repopulation, all of which may lead to increased resistance to infection at the surgical site, as shown in an animal model.* AlloDerm® Tissue Matrix ultimately transitions into host tissue for a strong, natural repair.
- Q: What testing is performed on AlloDerm® Tissue Matrix to ensure product safety?
A: AlloDerm® is screened and tested according to FDA regulations, American Association of Tissue Banks Standards, and appropriate state regulations.
- Q: Have there been any reports of latex reactions related to the use of AlloDerm® Tissue Matrix?
A: AlloDerm® Tissue Matrix is processed from cadaveric split thickness skin grafts. No latex products are added to the product or contained in any of the packaging material. Although some individuals contacting the tissue during the procurement of the skin or the processing of the grafts may have worn latex gloves, LifeCell is currently unaware of any reports of latex reactions, allergy or sensitivity related to the use of AlloDerm® Tissue Matrix.
- Q: Does AlloDerm® Tissue Matrix contain antibiotics?
A: AlloDerm® Tissue Matrix is contraindicated for use in any patient with a sensitivity to specific antibiotics listed on the package.
- Q: Why are there no Material Safety Data Sheets associated with LifeCell products?
A: LifeCell has reviewed the requirements of the OSHA Hazard Communication Standard, 29 CFR 1910.1200, with regard to our products and services. It is our determination that our products are not Hazardous Chemicals as defined in the Standard and therefore do not require a Material Safety Data Sheet.
- Q: How is AlloDerm® Tissue Matrix procured and processed?
A: AlloDerm® Tissue Matrix and Cymetra® Tissue Matrix are composed of donated human dermal tissue. This donated tissue is recovered, processed, stored and distributed in conformance with the regulations of the Food and Drug Administration (FDA) and various State legislatures as well as the Standards of the American Association of Tissue Banks (AATB). These regulations and standards require extensive screening and testing of the tissue donor as well as the transplant grafts. Serological screening includes, but is not limited to, tests for evidence of hepatitis, AIDS and syphilis. Additionally, LifeCell tissue grafts undergo a patented process that cleans and removes the cellular components while preserving and stabilizing the biochemical and biomechanical properties of the grafts.
*Correlation of these results to results in humans is not established. Before use, physicians should review all risk information and essential prescribing information which can be found in the AlloDerm® Regenerative Tissue Matrix Instructions for Use.