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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 Dr Maciel  tilapia Tilapia
 tilapia skin1  tilapia skin 2



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.






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