Wound care:


FDA APPROVES CARDIUM'S WOUND
CARE PRODUCT FOR DIABETIC FOOT
ULCERS
In October 2011 Cardium Therapeutics  
announced  that it has received 510(k)
clearance from the U.S. Food and Drug
Administration (FDA) to market and sell
the Company's new Excellagen
professional-use, sterile, syringe-based
advanced wound care product for the
management of diabetic foot ulcers and
other dermal wounds.

Excellagen should be used immediately
following surgical debridement (the
removal of damaged tissue or foreign
objects from a wound), which is routinely
practiced in the treatment of diabetic
foot ulcers and other dermal wounds.

In addition to diabetic foot ulcers,
Excellagen is also cleared for use in the
management of other dermal wounds
including partial and full-thickness
wounds, pressure ulcers, venous ulcers,
chronic vascular ulcers,
tunneled/undermined wounds, surgical
wounds (donor sites/grafts, post-Moh's
surgery, post-laser surgery, podiatric,
wound dehiscence), trauma wounds
(abrasions, lacerations, second-degree
burns and skin tears) and draining
wounds.  




PHOTOCHEMICAL TISSUE BONDING
TO REPAIR WOUNDS WITH LIGHT
Airmen's traumatic battlefield injuries
may be more effectively treated by using
a new light-activated technology
developed as a result of research
managed by Air Force Office of
Scientific Research.

This new treatment for war injuries
includes using a process  called
Photochemical Tissue Bonding, which
can replace conventional sutures,
staples and glues in repairing skin
wounds, reconnecting severed
peripheral nerves, blood vessels,
tendons and incisions in the cornea.

The procedure works by applying a
special pink dye to the skin around a
wound and zapping it with green light.
The dye -- called "Rose Bengal," which
is approved for diagnosis of eye
damage -- absorbs the light, exciting
electrons.

The electrons help create chemical
bonds between collagen fibers. The
collagen then links together across
opposite sides of a wound, acting as a
tiny seal. These "nanosutures" are more
effective than traditional stitches
because they're water-tight, leading to a
safer seal and less scar formation, and
they don't require puncturing healthy
tissue with a needle and thread. There
are no proteins or glues involved, which
can cause irritation or inflammation.

Harvard Medical School professor  Dr.
Irene Kochevar and her colleague
Associate Professor Robert Redmond
are both pleased with the initial lab
bench experiments that led to a pilot
clinical study.
"No glues, proteins or other materials
are used that might stimulate an
inflammatory response," said Kochevar.
"An immediate, water-tight seal is formed
between the tissue surfaces leading to
reduced inflammation in the near term
and better scar formation in the long
term."
What's more, the process can also be
used to reconnect severed nerves and
blood vessels, Kochevar says. The Air
Force was the impetus for the study, but
the technique could be used for injuries
in various situations.
"One of the applications for this
technology is putting nerves back
together, in the hands or legs, for
instance. That occurs as a result of
traumatic injury. It also happens when
you are at a 4th of July picnic and you
are cutting hamburgers and you run a
knife through your hand," she said. "So
it was developed for the battlefield, but
it's not limited to that."

As of now, research centers on the
molecular processes involved in creating
the nanosutures. It's not ready for field
surgery -- at least not yet.

Clinical trial no:  NCT00586040



APLIGRAF FROM  ORGANOGENESIS
TO HEAL HOPELESS FOOT ULCERS
To date, 250,000 patients have been
treated with Apligraf, and the company is
now in the middle of a $60 million
expansion of its manufacturing facilities
in Canton, USA. The new facilities are
expected to open in late 2013.

When a foot or leg ulcer lingers for
weeks months or even years without
healing, it can seem hopeless. It’s
frustrating when your body just does not
heal, no matter what treatments you try.
But there is real hope for healing your
ulcers with Apligraf, utilizing the latest in
biotechnology for wound care.

Apligraf consists of living cells, proteins
produced by the cells and collagen.
Apligraf® is not another ointment or
dressing. It is a living, cell based product
that helps promote healing of venous
leg ulcers and diabetic foot ulcers.
It is created from cells found in healthy
human skin. Which explains why it looks
like a thin piece of real skin.

It is used to heal ulcers such as diabetic
foot and venous leg ulcers that are not
healing after 3-4 weeks, despite
treatment with conventional therapies.

When healthy skin gets wounded, the
proteins and growth factors in the skin
stimulate the body to regenerate new
skin. This is the normal wound healing
process.

However with certain diseases (like
diabetes and circulatory problems), the
skin is missing these biological
substances, and the healing cycle is
broken. This leads to the development
of non-healing ulcers and wounds.

Apligraf contains two types of cells – an
outer layer of protective skin cells, and
an inner layer of cells contained within
collagen. Both types of cells contain
substances similiar to those found in
human skin. Apligraf does not contain
certain things in skin such as hair
follicles, sweat glands or blood vessels.

Apligraf plays an active role in healing
by providing to the wound living cells,
proteins produced by the cells, and
collagen, which are important for healing.

Apligraf is different because it is NOT a
cream, ointment, or traditional wound
dressing. It is a living treatment made to
treat non-healing ulcers.

Apligraf is placed directly on the wound.

The wound is then covered with a non-
adhesive dressing to keep Apligraf in
place. The area is then wrapped with
other dressings that are changed weekly
by the doctor or nurse. The healing
process now begins, and improvement
of the wound can usually be seen within
weeks.

Many wound therapies, like dressings
and antibacterial treatments, are
designed to manage a wound until the
body heals itself. Apligraf plays a more
active role in the wound healing
process. Apligraf delivers to the wound
living cells, proteins produced by the
cells, and collagen which are important
for healing.

Apligraf is a prescription product that
must be applied by a medical
professional. It is not available in
pharmacies nor can it be purchased
online.



NEXAGON: A GEL PREVENTS PROTEIN
TO BLOCK HEALING
A new  gel  has been  developed by a
team led by David Becker, a professor
of cell and developmental biology at
University College London and San
Diego (US) company CoDa
Therapeutics . The gel, named
Nexagon, works by interrupting how cells
communicate and prevents the
production of a protein that blocks
healing. That allows cells to move faster
to the wound to begin healing it.

Though it has only been tested on about
100 people so far, experts say if it
proves successful, the gel could have a
major impact on treating chronic
wounds, like leg or diabetes ulcers, and
even common scrapes or  injuries from
accidents.

In most chronic wounds, Becker said
there is an abnormal amount of a
protein involved in inflammation.
To reduce its amount, Nexagon is made  
from bits of DNA that can block the
protein's production.

The NOVEL Phase 2 Study was a
randomized, vehicle-controlled, double-
blind Phase 2 clinical study to evaluate
two doses of NEXAGON in patients with
venous leg ulcers. 98 patients  were
enrolled at sites in New Zealand and the
United States, and randomized on a 1:1:
1 basis to receive low or high dose
NEXAGON treatment, in addition to
compression bandaging (standard-of-
care). Patients  received three
applications over a four-week treatment
period.

For more than half a million patients in
the U.S. suffering from venous leg ulcers
each year, the wound healing process is
often time-consuming and costly, and
may gravely impact quality of life. Of all
ulcer types, venous leg ulcers are the
most common, resulting in the loss of 2
million working days and nearly $3 billion
in treatment costs per year in the US.

CoDa Therapeutics  is pioneering a new
field of science: gap junction modulation,
using a new class of therapeutics that
can modulate wound responses and
reduce inflammation.



BACTERIOSAFE:  A DRESSING WILL
RELEASE ANTIBIOTICS TO THE
WOUND
Researchers are using nanotechnology
to develop a medical dressing which will
detect and treat infection in wounds.

Scientists at the University of Bath (UK)
and the burns team at the Southwest UK
Paediatric Burns Centre at Frenchay
Hospital in Bristol are working together
with teams across Europe and Australia
to create an advanced wound dressing.

The dressing will work by releasing
antibiotics from nanocapsules triggered
by the presence of disease-causing
pathogenic bacteria, which will target
treatment before the infection takes hold.

The dressing will also change color
when the antibiotic is released, alerting
healthcare professionals that there is
infection in the wound.

This is an important step in treating
burns patients, particularly children,
where infections can lead to toxic shock
syndrome, a potentially fatal condition.

The €4.5 million European Commission
funded project is a collaboration of 11
partners across Europe and Australia
coordinated by Dr Renate Förch, at the
Max-Planck-Institute for Polymer
Research (Germany), which will develop
the prototype dressing over four years.



MANUKA HONEY: ONLY HONEY
RECOGNIZED FOR MEDICINAL
PROPERTIES
Made by bees that collect pollen from
the white-flowered manuka bush in New
Zealand, it is the only honey to be
scientifically graded for its medicinal
properties.
It is being used in hospitals around the
world to keep wounds free from
infection, treat stomach ulcers and even
boost the immune system of cancer
patients having chemotherapy.


OTHER DEVELOPMENTS

MEDIHONEY by Derma Sciences, Inc


MatriStem  Wound Powder for Finger
Amputation Repairs by Acell



A powder nick-named "Pixie Dust" is
being used to save the limbs of war
heroes who have been wounded in
Afghanistan.  The Extra Cellular Matrix
grew nerves, ordinary tissue and muscle
where there had been none.  
Pixie dust was developed by scientists at
the Centre of Regenerative Medicine in
Pittsburgh


Negative Pressure Wound Therapy -
NPWT: Engenex by Boehringer Wound
Systems;

Smith & Nephew has introduced a new
negative pressure wound therapy
system called RENASYS EZ;

Prospera PRO-I by Medica-Rents. Inc;

V.A.C. (various models) by KCI ;

Versatile 1 and V1STA by Smith &
Nephew;

Invia by Medela;

MIST Therapy by Celleration;

Time released antibiotics by Surmodics;

Chitosan based wound dressing by
Hemcon;

GelSpray Liquid Bandage - a spray-on
dressing for injuries by BioCure Inc;

Tranexamic Acid for Coronary Artery
Surgery in trial;

Artiss fibrin sealant for use in attaching
skin grafts onto burn patients by Baxter;

Biatain-Ibu delivering ibuprofen directly
into the wound by Coloplast;

Hyperbaric Oxygen Therapy For
Diabetic Foot Wounds;

Tygacil for MRSA wounds by
Wyeth/Pfizer;

ABThera Open Abdomen Negative
Pressure Therapy Unit and companion
ABThera Open Abdomen Dressing
product by KCI;