rexresearch.com
Edmar L. MACIEL
Tilapia Skin Burn Bandage
https://www.youtube.com/watch?v=5LOG7-2bNhQ
Can tilapia skin be used to bandage burns?
Doctors in Brazil are using the fish skin to treat burn patients.
The treatment, which is part of a clinical trial, is said to
reduce healing time by several days.
Dr Maciel
Tilapia
http://www.pbs.org/newshour/rundown/brazilian-city-uses-tilapia-fish-skin-treat-burn-victims/
https://www.statnews.com/2017/03/02/brazil-tilapia-skin-burns/
Why this Brazilian city uses tilapia fish
skin to treat burns
by
Nadia Sussman
FORTAZELA, Brazil — In this historic city by the sea in northeast
Brazil, burn patients look as if they’ve emerged from the waves.
They are covered in fish skin — specifically strips of sterilized
tilapia.
Doctors here are testing the skin of the popular fish as a bandage
for second- and third-degree burns. The innovation arose from an
unmet need. Animal skin has long been used in the treatment of
burns in developed countries. But Brazil lacks the human skin, pig
skin, and artificial alternatives that are widely available in the
US.
The three functional skin banks in Brazil can meet only 1 percent
of the national demand, said Dr. Edmar Maciel, a plastic surgeon
and burn specialist leading the clinical trials with tilapia skin.
As a result, public health patients in Brazil are normally
bandaged with gauze and silver sulfadiazine cream.
“It’s a burn cream because there’s silver in it, so it prevents
the burns from being infected,” said Dr. Jeanne Lee, interim burn
director at the the regional burn center at the University of
California at San Diego. “But it doesn’t help in terms of
debriding a burn or necessarily helping it heal.”
The gauze-and-cream dressing must be changed every day, a painful
process. In the burn unit at Fortaleza’s José Frota Institute,
patients contort as their wounds are unwrapped and washed.
Enter the humble tilapia, a fish that’s widely farmed in Brazil
and whose skin, until now, was considered trash. Unlike the gauze
bandages, the sterilized tilapia skin goes on and stays on.
The first step in the research process was to analyze the fish
skin.
“We got a great surprise when we saw that the amount of collagen
proteins, types 1 and 3, which are very important for scarring,
exist in large quantities in tilapia skin, even more than in human
skin and other skins,” Maciel said. “Another factor we discovered
is that the amount of tension, of resistance in tilapia skin is
much greater than in human skin. Also the amount of moisture.”
In patients with superficial second-degree burns, the doctors
apply the fish skin and leave it until the patient scars
naturally. For deep second-degree burns, the tilapia bandages must
be changed a few times over several weeks of treatment, but still
far less often than the gauze with cream. The tilapia treatment
also cuts down healing time by up to several days and reduces the
use of pain medication, Maciel said.
Antônio dos Santos, a fisherman, was offered the tilapia treatment
as part of a clinical trial after he sustained burns to his entire
right arm when a gas canister on his boat exploded. He accepted.
“After they put on the tilapia skin, it really relieved the pain,”
he said. “I thought it was really interesting that something like
this could work.”
The initial batches of tilapia skin were studied and prepared by a
team of researchers at the Federal University of Ceará. Lab
technicians used various sterilizing agents, then sent the skins
for radiation in São Paulo to kill viruses, before packaging and
refrigerating the skins. Once cleaned and treated, they can last
for up to two years.
In the US, animal-based skin substitutes require levels of
scrutiny from the Food and Drug Administration and animal rights
groups that can drive up costs, Lee said. Given the substantial
supply of donated human skin, tilapia skin is unlikely to arrive
at American hospitals anytime soon.
But it may be a boon in developing countries.
“I’m willing to use anything that might actually help a patient,”
Lee said. “It may be a good option depending on what country
you’re talking about. But I also think the problem is that you
need to find places that have the resources to actually process
the skin and sterilize it, and make sure it doesn’t have
diseases.”
In Brazil, in addition to the clinical trials, researchers are
currently conducting histological studies that compare the
composition of human, tilapia, pig, and frog skins. They are also
conducting studies on the comparative costs of tilapia skin and
conventional burn treatments. If clinical trials show continued
success, doctors hope a company will process the skins on an
industrial scale and sell it to the public health system.
WO2017035615
TILAPIA SKIN PROCESSING METHOD AND USE THEREOF FOR COVERING
SKIN INJURIES
Inventor: EDMAR MACIEL , et al
The present innovation relates to the use of Tilapia skin
processed in various steps on the basis of glycerol in
concentrations that vary from 50 to 99%, in types 5 and 7 clean
room environments and in certain cases, when microbial count is
high, with supplementary radio-sterilisation with gamma radiation.
The skin can be used as an occlusive biological dressing for skin
injuries, such as burn and acute or chronic wounds.
TECHNICAL FIELD
1- Innovation refers to the use of Glycerol-based, multi-stage
Tiiápia skin, in concentrations ranging from 50 to 99%, in Clean
Room Classification Environment Types 5 and 7 and, in some cases,
when The skin can be used in burns and acute or chronic wounds,
which consists in its application on the surface of lesions due to
II degree burns, Superficial or deep, in acute wounds, such as
donor skin areas for autografting, or chronic, in their Unal
stages of performing simple dressings, surgical dressings,
surgical debridements under anesthesia and autograft of the skin,
often present in these injuries .
STATE OF THE TECHNIQUE
2- Currently, medicine in Brazil does not have any heterologous
alternative skin cover alternative (from animal origin) as part of
the treatment of burns and wounds. In developed countries,
especially in the United States of America, Porcinandustrialized
Skin has been used for this purpose and on a large scale for
several decades. The importation of this product into Brazil has
never been commercially viable, considering its high cost and the
economic reality of the country.
DETAILED DESCRIPTION OF THE REVISION
3- The present invention describes the use of Tilapia skin in the
superficial treatment of cutaneous lesions, such as burns, chronic
crevices, among others, being obtained from psychoses, using
culture systems (tanks-net), passing through a Sterilization
process, as described below.
4- After slaughter, tilapia skins (weighing between SOO and 1000
grs) shall be removed with a turquoise (tool) and washed in
running water for the removal of any trace of blood and other
impurities and placed in physiological saline ( Sterile 0.9% aCI
solution), previously cooled to 4Â ° C, for final cleaning. Next,
the excesses of muscle, which still remain attached, will be
removed and cut into pieces of 10.0 cm x 5.0 cm, washed with SF,
following the following steps of sterilization.
5- 1 Step - the skins are placed in a sterile container containing
2% chlorhexidine gluconate (solution with surfactants), where they
remain po 30 min.
6- 2 Step - After the previous operation, the skins will be washed
with sterile SF and removed to another container containing
another 2% chlorhexidine gluconate solution, where they will
remain for 30 minutes.
7- 3 Step - the skins shall be rinsed in sterile saline and placed
in a container containing 50% glycerol solution, 49% saline
solution and 1% penicillin, streptomycin and fungisol solution and
packaged for the (Jaguari ara-NPDIM), in an ice-containing
isothermal box.
8~ The next steps will be carried out in the UFC NPDM, in a
sterile environment, with horizontal or vertical laminar flow.
9- Before 24 hours the pelts should be removed from the previous
solution, washed with sterile SF and placed in a sterile,
hermetically sealed container containing 75% glycerol, 24% saline
and 1% penicillin solution, Strepomyomycin and fungicide, wherein
the pellets are massaged for 5 minutes in this solution and held
for 3 hours in a water bath (centrifuge), with a stirrer at a
constant speed of 15 revolutions per minute and a temperature of
37 ° C.
10- Step - the pelts will be removed, washed with sterile SF again
and placed in another sterile and airtight container. Containing
99% glycerol, 1% penicillin, streptomycin and fungisol solution,
with foot massaging for 5 minutes In this solution and kept in a
water bath in a centrifuge at 37 ° C and 15 revolutions per minute
for a further 3 hours.
11- At the end of the last stage of gellcerol, the pellets will be
packaged in sterile double plastic envelopes and stored at 4 ° C
for later use, with a shelf life of up to two years.
12- Seven microbiological tests will be carried out for gram · *
gram-and-fungal bacteria, starting on the skin in natura, i.e.,
before the first stage and in the six stages described adma. When
Bioburden levels, used for bacterial counting, ie Bioburden
Microbiological Testing, or Microbial Test Strip, which is
performed on pharmaceuticals and medical products that require
control of microbial levels during processing and handling, are
within the Acceptable limits, the skin will be unavailable for
use.
13- When skins are to be used they will be removed from the
envelope and washed po three times in different solutions of
sterile saline for five minutes each step. After this procedure,
the skins will be trimmed to the size of the wound and applied as
an occlusive dressing.
14- If the bacterial count is above 10/3, a complementary
sterilization step, described below, should be introduced:
15- 7 Step - complementary radio-sterilization, Gamma-Cobalt
60, with dosages ranging from 15 to 50 Kilograys, depending on Bso
burden levels (microbial count).
16- The skin of the tilapia, when interacting with these lesions,
promotes the acceleration of the healing and repair processes of
the dermal matrix (by the action of the Type I Collagen in its
histological structure), by adhering to the wound, avoiding the
Retention of exudates and loss of fluids, promoting a barrier to
bacterial invasion and providing pain relief.