| Answers to your questions about AlloDerm®
Acellular dermal graft
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WHAT IS AN ALLOGRAFT?
An allograft is any human tissue that is transplanted from one
person to another. Kidneys, hearts, corneas, bone, skin, and other
tissues are generously donated by individuals or their families.
Allograft tissues have been used in millions of surgical procedures
for many years.
WHAT IS ALLODERM DERMAL GRAFT?
AlloDerm is donated allograft skin which is processed by LifeCell
Corporation to remove cells, leaving only the dermis, or bottom
layer of skin.
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HOW DOES LIFECELL OBTAIN DONATED SKIN?
Tissue banks throughout the United States surgically remove a
thin layer of skin from donors using sterile operating room techniques.
The skin is placed into an antibiotic solution and shipped to
LifeCell. Donors and their families receive no financial compensation
for these donations and donated tissues are not bought or sold.
However, fees are paid to cover the standard costs for obtaining,
testing, processing and shipping the tissues.
HOW LONG HAS ALLODERM BEEN USED?
Use of AlloDerm began in 1992 for burn patients and in 1994 for
periodontal surgery and plastic and reconstructive surgery. Currently,
more than 25000 patients have received AlloDerm grafts.
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| IS IT REGULATED
BY ANY AGENCY?
AlloDerm is regulated by the U.S. Food and Drug Administration (FDA)
as human tissue and is indicated for transplantation to repair or
replace damaged or inadequate dermal tissue. |
| HOW IS ALLODERM
MADE?
LifeCell Corporation processes the human donor skin in order to
remove the cells. This process involves removing the epidermis (the
top layer of skin cells) and all of the cells in the dermis. The
remaining material is a collagen framework which provides strength
to the skin. There are no components left to cause the rejection
or inflammation that can result with unprocessed tissue transplants.
Therefore, when transplanted to a patient, the AlloDerm graft gradually
becomes a natural part of the patient's own tissue and performs
like normal, healthy tissue thereafter. |
| ARE ALLODERM GRAFTS
SAFE?
Before LifeCell receives the skin, the tissue donors undergo rigorous
screening by the Tissue Bank. The donor's medical and social history
and cause of death are carefully reviewed and documented. Blood
samples are extensively tested by the Tissue Banks or a certified
laboratory using FDA-licensed tests. The donor must be found negative
for Hepatitis B and C, HIV Types 1 and 2 antibodies (screenings
for AIDS), and syphilis. As an extra safeguard, AlloDerm grafts
undergo microscopic and other analytical testing, both before and
after processing, to rule out pathogenic contamination and promote
uniform quality.
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| WHAT ABOUT HIV
TRANSMISSION?
Human pathogenic viruses, including HIV, require certain types of
human cells to be present and alive in order for the viruses to
live and grow themselves. These viruses essentially are "parasites"
of cells and cannot reproduce without them. The AlloDerm Process™
removes all cells, thereby removing the components necessary for
survival and transmission of these viruses. Additionally, after
cell removal, the AlloDerm grafts are freeze-dried. There has never
been a documented case of HIV transmission from the transplant of
any freeze-dried, processed tissue graft. |
| HOW IS ALLODERM
USED?
AlloDerm is used both as a surface skin graft for replacing skin
loss, such as from burn injuries or cancer excisions, and as an
implant that is inserted under the surface of the skin to correct
soft tissue defects. When applied as a surface skin graft, an extremely
thin autograft of the patient's own skin is placed on top, providing
skin color and texture. When used as an implant to repair or replace
damaged or inadequate tissue, AlloDerm can be folded, rolled or
stacked to provide the amount of tissue needed. AlloDerm has been
used both as a surface graft and as an implant for almost every
area of the body. Amounts of AlloDerm used in a surgery have varied
from extremely small, such as half of one square inch for gum surgery,
to more than 5 square feet in burn surgery. Dr Boris & Cheski
will determine the amount needed for your special procedure.
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WHY IS ALLODERM PREFERRED OVER OTHER PRODUCTS OR METHODS?
AlloDerm is the only available product capable of regenerating
normal soft tissue. AlloDerm has many advantages that make it
unique in comparison to other products. Since it is human tissue,
AlloDerm does not incite an inflammatory response or allergic
reaction, and the pretreatment skin testing required with animal
coliagen is not needed. Also, the graft does not have the feeling
of hardness that is reported with many synthetic materials. When
AlloDerm is used as an implant, it completely eliminates any need
to take donor fat or dermis from one part of the body to transplant
to another area. When used as a surface graft, surgeons only take
a very thin skin graft to place on top. This creates a very shallow
donor wound, eliminating or greatly reducing the problems often
associated with deeper donor wounds.
HOW WOULD ALLODERM BE USED FOR MY SURGERY?
Since AlloDerm is used in so many different types of procedures,
you should discuss your specific surgery with your doctor. In
surgery, the freeze-dried AlloDerm graft is rehydrated in a sterile
solution. When fully rehydrated, it is very soft and pliable,
feels just like your own tissue, and can be positioned or draped
wherever it is most needed.
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| WHAT SHOULD
I EXPECT AFTER MY SURGERY?
Again, since procedures vary so much, it is best to talk with your
surgeon. Therefore the guidelines that follow are very general.
As a surface graft:
When used as a surface skin graft, you will have a dressing
after the surgery that needs to stay securely in place until it
is removed by your surgeon. For the first I or 2 weeks of healing
time, you must treat the graft very carefully and take great care
not to disturb it. After it is completely healed, the graft will
be as sturdy as normal skin.
As an implant:
When placed as an implant, you are likely to have some sutures closing
the surgical incisions. You may be asked to keep an antibiotic ointment
on the sutures for a few days until the incisions are heated, and
there may or may not be a dressing over them. Dr Boris & Cheski
will give you more detailed information on how to take care of your
surgical area to prevent infection and may also prescribe antibiotics
for you to take.When placed below the surface of the skin as an
implant, some swelling should be expected and possibly mild bruising,
simply because of trauma to the area from the surgical procedure
itself Your surgeon may apply a compression dressing and advise
the use of an ice-pack on the area for a day or two.Although much
of the swelling will be gone within a few days, the healing process
will continue. Surgeons have reported that the entire healing process
takes at least 2 months. During this period, the graft sometimes
feels slightly firm. Firmness may persist longer if you develop
a postoperative infection, react to the suture material, or if you
had other materials previously implanted or injected into the same
area. As the graft heals and becomes a part of your own tissue,
it softens; in several months, it should feel no different than
the surrounding skin. Healing time varies among individuals and
with different procedures. Complications may result if the AlloDerm
is removed after one month, since by that point in the healing process
the graft has incorporated into your natural tissue.After healing
is completed, you will no longer feel the AlloDerm graft, but it
will still be present. It simply will have become a normal part
of your own skin. If you need additional tissue contours after any
firmness has subsided, consult with your surgeon about having more
AlloDerm placed.
REFERENCES1. Simonds Rj, Holmberg SD, Hurwitz,
RL, et al. Transmission of human immunodeficiency virus type I from
a seronegative organ and tissue donor.
The New England journal of Medicine. 1992; 326(11):726-732.2.
Sykes, JM and Emery, BE. Upper and lower lip augmentation with dermal
autografts. Operative Techniques in Otolaryngol 5(4):307-10,
1995. |
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