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Not Your Run-Of-The-Mill Bandage

Entegrion partners with Carolina textile mills to develop revolutionary Stasilon™-FR hemostatic bandage.

Janet Bealer Rodie, Associate Editor

W hen life sciences company Entegrion was asked by the Office of Naval Research (ONR), Arlington, Va., to develop an affordable bandage that would quickly stop bleeding in combat-inflicted wounds, the Research Triangle Park, N.C.-based start-up turned to local textile manufacturers to help it devise a solution. The combination of the expertise and creative, out-of-the-box thinking of Entegrion’s chief science officer, Dr. Thomas H. Fischer, with the knowledge and can-do, willing-to-take-a-risk attitude of the textile makers resulted in the development of Stasilon™|FR, the first in what is poised to become a line of hemostatic bandages with applications ranging from surface cuts and wounds to nosebleeds to surgical uses.

Entegrion was formed in 2002 to commercialize technologies being developed in the blood research area at the University of North Carolina at Chapel Hill (UNC-Chapel Hill), where Fischer, a company co-founder and vice president, is scientific director of the Francis Owen Blood Research Laboratory. According to E.S. “Stan” Eskridge Jr., CEO, president and also a company co-founder, Entegrion does a lot of work with the US military and has received military funding to help it develop its products.

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As a practical solution to satisfy the ONR’s requirements, Fischer sought to develop a bandage that is as close to gauze as possible, Eskridge said, “so we got him together with some guys from the textile industry, who supplied him with different fibers to test.” After testing numerous fibers, Fischer settled on a combination of medical-grade continuous glass filaments and bamboo.

“Glass initiates the coagulation of the blood, but it needs to be combined with something that will help wick blood to the glass and make the bandage feel like cloth,” Eskridge explained. “ Bamboo is almost as hemostatic as glass, yet it has great wicking properties, and the combination of the two works very well.”

stasilonstack
The fabric used in Entegrion’s Stasilon™ products is woven by Carolina Narrow Fabrics Co. using bamboo yarn spun by National Spinning Co. and glass filament. The patent-pending weave structure maximizes the effectiveness of the glass surface and the bamboo woven through it.

Yarn Development

Originally, Entegrion worked with Cheraw Yarn Mills, Cheraw, S.C., to convert fiber into yarn, and Cheraw was actively involved in evaluating the different fibers and developing Entegrion’s patented technology, Eskridge said. However, after Cheraw merged with Sanford, N.C.-based Frontier Spinning Mills Inc. in 2006, it restructured its yarn programs, and the yarn conversion for Stasilon now is handled at National Spinning Co. Inc.’s Alamance Spinning Plant in Glen Raven, N.C., about 35 miles down Interstate 40 from Entegrion.

According to Jim Booterbaugh, vice president of operations at National Spinning, Entegrion’s project presented a bit of a challenge, but one that could create some excitement and opportunity. Founded in the 1920s, first as a wool spinner and later adding acrylics and polyesters, National Spinning, with headquarters in New York City, today is adding out-of-the-box, value-added niche products to help it compete in the global trade environment.

“When Stan Eskridge came to us with the concept of making a bamboo yarn for a high-tech bandage, at first we thought that might be way out of our box,” Booterbaugh said. “And then we thought, well, maybe not, and as we looked into it more, we recognized it’s not too far from other specialty products we’re doing with higher-tech fibers. Plus, it’s an exciting end-use. So we said, ‘Well, it’s not huge at the start, but it will get us used to making bamboo yarns, and as other opportunities come up for bamboo, we’ll be able to do it.’”

Booterbaugh said it was necessary for National Spinning to fine-tune its spinning processes a bit to accommodate the bamboo fiber, “but it ended up needing surprisingly little. Rather than reinventing the process, we just needed to modify the way we did things a bit,” he said.

The project with Entegrion has led National Spinning to look into other market opportunities, Booterbaugh said. “Since we’ve started running this product, we’ve looked at other opportunities to spin finer-count bamboo for apparel and other applications. We’ve seen interest for end products that are already in the market, and we’re confident we can participate in those areas now.

“This particular program is not for a high-volume product, but it has value,” he added. “A year from now, I may say it was the best thing we ever did because we could leverage this program into three or four other programs. It offers a lot of potential.”

fischer




Dr. Thomas H. Fischer, Entegrion's chief science officer, tested a number of textile fibers before settling on a combination of glass filaments and bamboo to make a hemostatic bandage that is as close to gauze as possible.

 

Weave Structure Matters


National Spinning does not incorporate the glass into the yarn it spins for the Stasilon bandage. That filament is added at the weaving stage by Carolina Narrow Fabric Co. (CNF), a specialty narrow fabrics weaver located about 35 miles further down I-40 in Winston-Salem, N.C. As Entegrion’s Fischer began to work with CNF, he found that yarn properties are but one contributor to the bandage’s function, Eskridge said. “We discovered after we had the yarn converted that the way yarns are woven together also makes a difference,” he explained.

Entegrion’s requirements also presented a challenge to CNF. The family-owned company, which also has been in business since the 1920s, manufactures a range of narrow fabrics for medical and various other industrial applications, and uses fiberglass in composites and other fabrics; but the fiberglass/bamboo combination was a totally new concept to Jeffrey Freeman, CNF’s vice president of operations, who represents the third generation of the company’s present owners.

“We’d never heard of this,” Freeman said. “We’ve woven gauze for the medical industry for years, and we’ve always had to separate anything that had fiberglass from the gauze.” But the company set to work weaving fabric samples for Fischer to take back to the lab and test. Within a couple of months, CNF and Fischer arrived at a structure that, with some final tweaking, now is the Stasilon bandage.

savio
The bamboo yarn going into Stasilon products is spun on one side of a Savio open-end spinning machine at National Spinning’s Alamance Spinning Plant.

A Bandage That
Doesn’t Look Like A Bandage


The final product does not look like a typical bandage. As Booterbaugh put it, “This is not the Band-Aid you would have in your medicine cabinet.” Rather, he said, it is heavy compared to conventional gauze bandages.

Freeman said the surface area of the fabric is primarily glass fiber, which does not absorb the blood but does help it to clot, and the bamboo weft yarn wicks the blood to the glass surface. He also pointed out bamboo’s antimicrobial properties as being important, but not as important as the clotting factor provided by the glass fiber. 

“The weave structure is not an industry-standard,” Freeman said. “It’s kind of like a twill, but we had to change harnesses to get the surface area correct. The bandage doesn’t look like a gauze bandage — it looks like something we would sell to a gasket company or for heating systems or ovens.” He added that CNF and Entegrion have applied for a patent for the fabric construction.

Freeman also commented on the need to keep the manufacturing environment free of lint, infectious materials and other dirt; and talked about the finishing process, saying: “During the weaving process, you don’t want any type of bioburden on it. After weaving, we do a wash treatment in our dye facility and package the fabric and send it to Entegrion.” He noted that CNF has been a Food and Drug Administration (FDA)-approved facility for 30 to 40 years and is well-acquainted with the regulatory standards for medical textiles.

carolinamen
Left to right: Jeffrey Freeman, vice president of operations; Horace Freeman, CEO; and Horace “Buster” Freeman Jr., president, represent three generations of the family that has owned Carolina Narrow Fabric Co. since 1979.

Working With What Nature Already Does

According to Eskridge, the bandage stops the bleeding within minutes and is more than twice as effective in reducing blood loss as a traditional gauze bandage.
 
“A shaving knick will be cleaned up very quickly and will leave no scab. Nosebleed stops within two to three minutes,” he explained. “For a severe injury, you would push it into the wound and hold with pressure for three to five minutes and check to see if bleeding has stopped, which it often has. It’s really remarkable.”

In heavy bleeding, he said, using the bandage will delay the onset of hemorrhagic shock, which will extend the possibility of saving lives.

“As opposed to cotton gauze, where blood flows into the gauze structure and a scab forms, this product causes clotting in the ruptured blood vessels themselves and not on the bandage,” he explained. “It causes the blood vessels to constrict to shut off the blood flow. Tom [Fischer] is so good at not overpowering nature but working with what nature already does, so he engineered this to trigger that vasoconstrictive effect, giving us a product that can be removed without causing rebleeds.”

Although it was developed originally for the military, Stasilon|FR is currently being offered for use in emergency, first-responder situations for surface wounds. It is the first product in the line to be approved by the FDA, and that approval includes both prescription and over-the-counter uses. Eskridge said Entegrion also expects to receive FDA approval in the next few weeks for Stasilon|OR hemostatic surgical pads and Stasilon|OTC consumer products for the control of problem bleeding.

Over the next year, the company  plans to release four to five other versions based on the same core technology, including Stasilon|ENT for nosebleeds and hemostatic pads for delivery by surgical instruments to control internal bleeding.
 
“A lot of people are very, very interested in the product because there just isn’t anything in the market that’s comparable to it,” Eskridge said. “And, it’s patent-protected, and that will inhibit knock-offs.”

Evaluations of the Stasilon technology by military, emergency room and emergency medical service operations around the Southeast are now underway. Entegrion expects to launch FR, OR and OTC products in the marketplace this spring.

Looking Toward
The Next Product Generation


Entegrion recently brought in Dr. Marian McCord, a textile engineering specialist currently on sabbatical from North Carolina State University (NCSU), Raleigh, N.C., to work with Fischer and help the company develop the next generation of its textile wound care products. McCord is an associate professor in the Joint Department of Biomedical Engineering with UNC-Chapel Hill and NCSU; and also is director of the Tissue Engineering Laboratory, co-director of the Atmospheric Plasma Laboratory and associate professor in the textile engineering department at NCSU’s College of Textiles.

“Marian will work with us to take the hematological properties of these fibers and see if we can convey those into synthetic fibers that would be more controllable and cheaper to produce,” Eskridge said.

These next-generation fibers would replace the current bamboo/glass combination, he added, noting that bamboo fiber, though it may be spun into yarn in the United States, is produced offshore. “This would bring production totally into the United States.”

Eskridge expressed great appreciation for the contributions of Entegrion’s textile partners to the development of Stasilon.

“Tom Fischer is one of the most creative, innovative and experienced hematologists around, but without the expertise from Cheraw, National Spinning and CNF, we never would have come up with this product,” he declared. “It was textile knowledge in combination with hematology expertise that made the thing work.  The willingness on the part of the textile industry in this area to be innovative, and take risks to be innovative, is what’s going to turn this industry around.

“It’s been a great learning experience to work with these people,” Eskridge added.

March/April 2008