Daily Southtown, Tinley Park, IL
March 16, 2004
Used with Permission
In total pain but "blessed" to be alive, Tim Gould
of Sterling, Ill., drove two hours to Loyola University Medical
Center in Maywood to speak with a woman's family from Hickory
Hills while she rests in a drug-induced coma.
After all, he said, it was the least he could do for the Loyola
team who saved his life. And because he has been through what's
she is enduring, he wanted to offer some hope.
Gould, a former concrete worker, was set ablaze nearly three
years ago when using a torch to cut steel. The torch ignited
vapors and exploded a 55-gallon drum of Acetaline, resulting
in third-degree burns covering 97 percent of his body.
Samar Hadid was left with burns covering 85 percent of her body
after a home fireplace accident in December.
Gould and Hadid have something else in common. Each has skin
grafts that used what is sometimes referred to as "shark
skin," a term mentioned by Hadid's husband, Aladdin, when
outlining his interpretation of the doctor's planned course
of treatment to a Daily Southtown news reporter.
"That's a goofy name," said Dr. Richard Gamelli, Gould's
and Hadid's doctor and the director of Loyola's Burn Center,
who said "shark skin" may come up when he explains
options to burn patients' families. "It's not really 'shark
skin,'
per se."
What is it?
The artificial skin does contain a substance made from shark
cartilage, not shark skin. But the main ingredient comes from
collagen taken from cows' tendons.
The story, though, isn't what is in the synthetic skin, but
how it works to kickstart the body's new cell growth.
"We've been able to mimic Mother Nature," Gamelli
said.
Two new products by the same manufacturer - one approved by
the Food and Drug Administration and on the market, another
to be available by summer - add to the buzz word in the field
of bioengineered tissue: Integra.
While the hot commodity just a few years ago was Apligraf, a
tissue made with cells from neonatal foreskin, Integra skin
does not use human tissue.
Called Integra Dermal Regeneration Template and manufactured
by New Jersey-based Integra Life Sciences, the artificial skin
is a very thin sheath that somewhat resembles plastic wrap.
It is used for severe burn patients who have very little healthy
skin remaining to graft. (Grafting is the process of removing
or "harvesting" skin from a healthy area of the body,
or from a cadaver, and placing it where needed).
Patients with burns covering at least 60 percent to 70 percent
of their body may undergo a total of 20 or more skin grafts
over several months. Further demonstrating the need for alternative
skin resources is the fact that burns are the biggest trauma
a body can suffer, and many patients are too ill to withstand
another graft of their own skin, called an autograft.
Integra skin can be used immediately to seal a wound, as opposed
to an autograft being the first step.
The FDA approved Integra skin in 1996 and expanded its approval
in 2002 for treating burn victims' disabling scars, the biggest
reason it's used in reconstructive surgery at University of
Chicago Hospitals.
Integra skin also is used "off label" to treat scars
caused by something other than a burn, such as the removal of
a cancerous tumor, and to fill deep holes left by venous and
diabetic ulcers.
"We're constantly searching for synthetic replacements
for these holes people get," said William Ennis, D.O.,
medical director of the Wound Treatment Program at Advocate
Christ Medical Center in Oak Lawn.
The trauma facility first used Integra skin in wound care, including
plastic surgery, nearly four years ago on a south suburban woman
whose skin from groin to toes was shredded by a factory machine.
In other cases, Integra skin saved patients' limbs from amputation.
"And it takes all the itching out," said Christ's
Dr. Ramasamy Kalimuthu, who recently was named one of the top
10 plastic surgeons by Chicago magazine.
In burn and wound care, Integra skin yields a smooth surface
and allows for better mobility. Autografts, on the other hand,
can be scaled and rough in appearance and result in scars that
contract and create stiff to immobile joints.
Autografts require larger donor sites because they shrink, but
Integra skin keeps its shape and strength.
Overall, the improved treatment with Integra skin can help patients
stave off depression.
Integra skin helps patients handle trauma better, inside and
out.
"Integra represents a new advantage," Gamelli said.
More than 100 commercial outlets exist today for shark cartilage,
including cancer treatment and prevention, according to the
American Medical Association.
How does it work?
We may be most familiar with the varieties of chondroitin sulfate
touted for arthritis sufferers and made from shark cartilage.
The anti-inflammatory property in Integra skin, along with cow
collagen, is what lends to better healing and less scar tissue.
"The combination makes it very non-inflammatory and friendly
for cells to come in and degrade the collagen in a very normal
manner," said Tom Tarca, Integra vice president of marketing.
Ennis agreed. "It's a re-creation of what you have in your
own dermis," he said. "There is no (other) product
out there that breaks down slowly the way this does. The point
is to have less of a reaction so you can heal more normally."
Gould, the Loyola patient who is walking despite early predictions
against it, and known in his small town as the "Miracle
Man," put it simply: "They used 'shark skin' as sort
of a permanent temporary thing."
Integra skin has two layers.
The top layer is made of silicone and temporarily closes the
wound. Like our own skin, it fights infection and controls fluid
loss. It also protects nerve endings, leading to improved pain
management.
The bottom layer provides a scaffolding or framework for blood
vessels and dermal skin cells to slowly grow into and create
a new layer of skin, which does not occur with autografts.
"It is used to provide a receptive site for subsequent
reconstruction, kind of like a primer before applying paint,"
University of Chicago Hospitals spokesman John Easton said.
Once the Integra collagen is absorbed and replaced by human
collagen to form a new dermal layer, about 14 to 21 days later,
the silicone layer is removed. A thin autograft is permanently
placed over the site.
At Christ, a diabetic patient with a foot so infected that tendons
and muscles were exposed had Integra skin stapled in place and
was sent home for those 21 days. Before Integra, his condition
would have required major surgeries and an extended hospital
stay, Ennis said.
Are there drawbacks?
"You try wrapping it on extremities, it's like trying to
wrap a bowling ball," Loyola's Gamelli said.
Integra skin works best on large and flat surfaces such as the
chest, stomach or thigh. It does not do well on the back, however,
because "it doesn't like being laid on," he said.
In Gould's case, the Integra skin was used only on his chest
and abdomen, although his behind suffered worse burns. The skin
can't tolerate any pressure. Gould said rods were drilled through
his knees and ankles to place him in suspended traction to prevent
any pressure points.
Wound specialists know that heavy bacteria comes with the territory.
Burns, though, don't have as much.
Integra skin is highly sensitive to bacteria and can turn soupy
when affected by bacteria-released toxins.
"I don't think it's a big drawback," Ennis said. "You
just have to change gears a bit to have as pristine a bed of
tissues
as you can."
The cost of Integra skin is another concern. An 8-by-10 inch
sheet costs more than $1000. Health insurance coverage has been
variable.
What are other Integra products?
The results from Integra skin have been so remarkable that
some specialists are puzzled why it is not more prevalent.
"Everybody's getting good results," Ennis said, noting
that Integra was a hot topic at a national wound-care conference
in December.
Integra, which Jan. 1 ended its marketing and distribution relationship
with Johnson & Johnson, also has a similar skin called Bilayer
Matrix Wound Dressing. It recently was approved by the FDA for
burns, chronic wounds and trauma and is now on the market. Physicians
can peel it, open and use, whereas the Integra skin template
must be unfrozen, rinsed and sterilized in dunking tanks.
Another product, Integra's Matrix Wound Dressing, is a single-layer
skin without the silicone. It is approved by the FDA and expected
to be available this summer, Tarca said.
By year's end, experts say, the wound dressings should be covered
by Medicare, meaning hospitals will see a return on investments.
The dressings are expected to be used in more outpatient settings
too.
"This will take off," Ennis said, "and people
will use it all over the place."
INTEGRA® Dermal Regeneration Template is manufactured
and marketed by Integra LifeSciences Corp., Plainsboro, N.J.