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Clinical Trial: Glass Nanofibers Aid Wound Healing

Borate glass nanofibers (Peter Wray, American Ceramic Society)

Borate glass nanofibers (Peter Wray, American Ceramic Society)

A trial of super-thin glass fibers show the fibers helped heal venous stasis wounds in eight of 12 patients who had not responded to other treatments. Results of the small-scale early trial appear in the May issue of the American Ceramic Society’s Bulletin magazine.

The fibrous glass material (pictured left) is produced by Mo-Sci Corporation in Rolla, Missouri that develops glass-based materials for medical applications. The material is a borate composition called 13-93B3 glass that forms into cottony glass fibers, 300 nanometers to 5 micrometers in diameter.

The researchers knew from earlier studies that lithium borate glasses had beneficial effects against bacteria, such as E. coli, salmonella and staphylococcus microbes. However, earlier use of glass fibers from silica were designed for hard-tissue (e.g. bone) regeneration, not soft tissue.

To work with soft tissue, the researchers aimed to find a material that could mimic the microstructure of fibrin that forms the basis of a blood clot. They found that the structure of boron bioglass material appeared to have properties that assist the migration of epidermal cells and help the body regulate the healing process of open wounds.

Glass scientist Steve Jung and co-developer Delbert Day, founder of Mo-Sci Corp., tested their material successfully on animals and approached the Phelps County (Missouri) Regional Medical Center, also in Rolla, to conduct a human trial. All of the 13 participants recruited for the trial that began in August 2010 had diabetes and several of them had wounds that had not healed for more than a year. (One participant dropped out of the study early on.)

All of the patients 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 unusual 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, even bruises, can quickly erode and turn into large and deep wounds. Treating the wounds often requires expensive vacuum-assisted healing systems that must be carried by the patient at all times.

For the trial, Mo-Sci produced individual, foil-sealed packets containing pads made of the glass fibers. The medical center’s registered nurse who administered the treatments shaped the material to fit the open wounds, then covered the material with a secondary covering or compression wrap.

The results indicate that the wounds in eight of the 12 participants  healed completely and with little scarring. Among the eight patients, the wounds closed at a rate of 0.3 to 0.8 millimeters per day. The other four participants, according to the nurse administering the treatments, made some healing progress, but not complete.

The company now plans expanded human trials in partnership with the Center for Wound Healing and Tissue Regeneration at the University of Illinois at Chicago. Tests of the material are expected to begin this summer.

Read more: Partnership to Develop Sensors for Wound Infections

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