The U.S. Food and Drug Administration (FDA) clearance Silverlon,
a product to manage certain blister injuries caused by sulfur mustard, marks
the first medical countermeasure for this chemical threat.
Silverlon is a silver-plated nylon dressing available
commercially and used widely to aid in the management of acute skin wounds and
first- and second-degree thermal burns. The silver plating helps kill bacteria
within the dressing, and one dressing can be used for up to seven days. This
allows for fewer dressing changes, which reduces the burden on caregivers and
minimizes the pain and damage that would occur if the wound was disturbed.
“Chemical weapons like sulfur mustard cause horrific,
painful, and life-altering injuries, yet in the 100-year history of sulfur
mustard use, no medical countermeasures existed – until now,” said Biomedical
Advanced Research and Development Authority (BARDA) Director Rick Bright, Ph.D.
“This clearance exemplifies BARDA’s ongoing commitment to our partners and the
nation as we seek out promising technologies and products to improve our
nation’s health security and protect Americans.”
Argentum Medical, LLC, has received FDA clearances for multiple indications for Silverlon since 2003. Silverlon is incorporated into numerous deployed Medical Tactical Combat Casualty Care kits and is also supplied in bulk to Combat and Support Hospitals and Tactical Forward Surgical Teams. The wound dressing is also included in burn care protocols in the Joint Theater Trauma System Clinical Practice Guideline.
Silverlon burn products and protocols are extensively used by the US Army and by US Air Force Critical Care Air Transport (CCAT) teams and are taught at the US Air Force School of Aerospace Medicine Critical Care Air Transport Basic Course.
Beyond the military, Silverlon dressings are used today by surgeons and other healthcare professionals around the world on surgical wounds, in negative pressure wound therapy, on chronic wounds, burns, skin grafts, and IV and catheter-related wounds.
BARDA provided technical expertise and funding to support
the studies necessary to show that the product, Silverlon, is appropriate for
use on first- and second-degree skin burns caused by exposure to sulfur
“The FDA plays an important role in preparing our nation
for a range of threats, including chemical, biological, radiological, and
nuclear threats, providing guidance and support for the development of medical
countermeasures that can be used safely, effectively and reliably during public
health emergencies,” said Acting FDA Commissioner Ned Sharpless, M.D.
BARDA’s support for this additional indication began in
2013 as part of the federal government’s effort to repurpose approved drugs and
medical products to save lives and reduce injury in an attack on the United
This multi-purpose approach has proven to be
cost-effective in preparing mass casualty emergencies from chemical,
biological, and radiological agents. Repurposing products in widespread use
additionally ensures first responders have a familiar product to use in a time
Beginning in 2015, BARDA used Project BioShield authorities and the Project BioShield Special Reserve Fund to purchase Silverlon for the Strategy National Stockpile as part of BARDA’s burn countermeasure program. BARDA continues to work with Argentum on studies necessary for FDA clearance of Silverlon for use on radiation burns.