Why isn't alloderm sterile?
Why Isn't Alloderm Sterile?
Doctor Answers (6)
Aseptic versus sterile for Alloderm: A Concern?
The key issue regarding Alloderm and other acellular dermal matrix products is if they possibly contain transmissable infectious agents such as viruses or bacteria. The techniques involved in the preparation and processing of these materials destroys these living agents but does not destroy the tissue matrices which is important for their effective usage. Sterilization such as by heating would denature the proteins and render the products less effective or durable.
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AlloDerm: Common Questions
AlloDerm is derived from human skin and has been deemed aseptic – meaning that it has been developed under sterile conditions. The tissue matrix lacks living cells which makes it less capable of eliciting an immune response. In essence, the AlloDerm acts as scaffold for integrating living tissues.
AlloDerm is a tissue matrix used in reconstructive surgeries. It is derived from human skin which is prepared through a complex enzymatic process which subsequently removes all cells and relevant immuno-reactive cellular components such DNA without disturbing the extracellular matrix. The type of processing utilized is deemed "aseptic". Reports of Infection as a "source" from Alloderm approach zero.
Glenn Vallecillos, MD, FACS
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Alloderm is aseptic not sterile because that would destroy the matrix
There are a number of products that are intended to compete with Alloderm, an acellular dermal graft. The proprietarty process that is used to create Alloderm removes all of the cells while preserving the collagen matrix, so that the body recognizes it as "self" and it is incorprated as living tissue. Sterilization damages the matrix so the other products provoke an inflammatory response. However, Alloderm is aseptic, and is not associated with any increased risk of infections and the type of problems one might expect.
Sterility and alloderm
Good question. It is not sterile, but is aseptic. They process material via a proprietary technique that is not public knowledge to protect the market share of their product. The sterility is generally not an issue and will certainly not transmit transmit viruses like HIV and others. To sterilize it, I believe, weakens the material, but this is a guess. This question has led some practitioners to choose Surgimend or other competing products for their surgeries. Hope this helps.
Alloderm and sterility
From my understanding, there is concerns about changing the composition of the tissue and a desire to leave it in its most natural state. Having said that, from the best of my knowledge, the processing, if followed, does render the vast majority of all known transmissible infectious disease harmless.
These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.
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