Imagine
a battlefield medic or emergency medical technician providing first aid
with a special wad of cottony glass fibers that simultaneously slows
bleeding, fights bacteria (and other sources of infection), stimulates
the body’s natural healing mechanisms, resists scarring, and—because it
is quickly absorbed by surrounding tissue — may never have to be removed
in follow-up care.
Or,
imagine diabetics with hard-to-heal wounds finding a source of relief
from the battle against infections and limb amputation.
Those
scenarios are the hope of the developers of a revolutionary borate
glass nanofiber material, which appears have sped and helped the final
of healing long-term wounds in eight out of 12 venous stasis wound
sufferers in a recent clinical trial held at a medical center in Rolla,
Mo.
Details
about the trials and the glass fiber material were published today in
the May issue of the American Ceramic Society’s Bulletin magazine.
The
story reports on the discovery of the fibers and on an empirical study
that began late in the fall of 2010 supervised by the internal review
board of the Phelps County Regional Medical Center. The trial groups
originally had 13 volunteer members, but one dropped out during the
early stages.
According
to Peggy Taylor, the PCRMC registered nurse who administered the
treatments, all of the volunteers who took part in the trial are
enthusiastic about the use of the glass fiber product, which she says
“looks like cotton candy.”
“All
of the participants had diabetes and several of them had wounds that
had been unhealed for more than a year,” says Taylor, a specialist in
wound care. “One patient had the same wound for three years. After using
the glass fiber product for a few months, we were able to repair the
skin in eight of the patients. Remarkably, the other four have made a
lot of progress and all of their wounds should be healed soon, too.”
The
patients in the test group suffered from problems associated with
venous stasis, a condition where blood circulation in extremities is
poor. As the blood pools, typically in lower legs, fluids accumulate
causing unusually high pressure on skin tissues. Sores and wounds can
then develop when the fluid “weeps” from skin cracks, cuts or abrasions.
Because of an enzyme in the weeping fluid, the skin surrounding small
venous stasis injuries can quickly erode and turn into large and deep
wounds. Even small bruises can eventually develop into bone-deep
openings.
The
goal of the PCRMC trial was to provide an initial evaluation of the
effects of the novel fibrous glass material produced by the Mo-Sci
Corporation, a Rolla company already known for creating glass-based
materials for medical applications.
“Bioglass”
materials aren’t particularly new to the medical field, but thus far
all bioglass has been formed from silica-based glass compositions, and
these primarily have been used in hard-tissue regeneration, such as bone
repair.
Glass
scientist Steve Jung, who helped develop the new material, says he and
co-developer Delbert Day had wondered whether a different type of
bioactive glass material could be used for soft-tissue regeneration.
“Our in-vitro studies showed that bioactive glasses containing boron
should react to body fluids much faster than silicate glasses,” says
Jung, who obtained his Ph.D from Missouri University of Science and
Technology, where he conducted his research with Day, a professor at the
university. “We also knew that another in-vitro study of lithium borate
glasses had showed it to have beneficial effects against bacteria, such
as E. coli, salmonella and staphylococcus microbes.”
Lastly,
Jung and Day recall they were interested in a composition that was rich
in calcium. “Previously, investigators have reported that calcium is
important for wound healing. It appears to assist the migration of
epidermal cells and help the body regulate the healing process of open
wounds,” says Jung.
Besides
composition, Jung and Day thought the structure of the material may be
important to consider, too, and suspected that providing a healing
“scaffold” might be beneficial to skin reconstruction. “We wanted to
have a material that could mimic the microstructure of fibrin that
normally forms the basis of a blood clot. We reasoned that if the
structure could imitate fibrin, it might trap blood platelets and allow
the formation of a wound cover that could support the healing process.”
Jung
and Day finally settled on a particular borate glass composition —
called 13-93B3 glass —that Mo-Sci, a company founded by Day, already
knew how to form into cottony glass fibers, 300 nanometers to 5
micrometers in diameter.
After
animal tests showed no adverse effects, Mo-Sci obtained a license to
the material from Missouri S&T, named the borate glass material
“DermaFuse,” and approached PCRMC about starting the small-scale human
test.
PCRMC
approved the trial in July 2010, and nurse Taylor saw her first patient
one month later. Once the study was underway, the company provided
Taylor with individual, foil-sealed packets containing pads made of the
glass fibers. She says the material is easy to apply. “You can form it,
pick it, make it into any kind of shape you need out of it. I used
tweezers to pack the material up into all of the recesses before filling
the rest of the wound. I didn’t pack it hard, but enough to fill all
the crevices. Once it was in place, I covered it with a secondary
covering or compression wrap.”
One
thing that surprised Taylor was that the glass fibers seem to disappear
over time, a phenomenon that has been observed with other bioglasses.
“Does it dissolve? Does it become part of the tissue? We don’t quite
know, but it is just such a neat thing to watch that process,” she
marvels.
Taylor
acknowledges that under her care, the wounds would have probably healed
without the glass material, but they would have required expensive
vacuum-assisted healing systems that must be carried by patient at all
times.
Besides
low cost and ease of use, Taylor says the glass fibers seem to offer
another stunning benefit: low scarring. “All but one of the patients in
the trial were elderly and had a lot of skin discoloration, but we
healed wounds that show nothing or negligible scarring,” she reports.
Jung,
who now works as a senior researcher for Mo-Sci, says that the next
step is expanded human trials, which will be conducted in partnership
with the Center for Wound Healing and Tissue Regeneration at the
University of Illinois at Chicago. He says the center has agreed to
begin testing the material this summer.
In
the meantime, Jung says he and Day are optimistic about a new era in
wound treatment. “We are really hoping the properties of these fibers
can help with more extensive wounds, such as burns, and we easily
foresee the day when soldiers or EMT workers carry packets of these
glass fibers to provide healing protective covers that don’t have to be
removed.”
