FDA has cleared a wound dressing for use in the treatment of blisters caused by mustard gas. The Department of Health and Human Services touted the clearance Monday as an important first product of its kind in addressing potential chemical weapon attacks.
Geneva, Illinois-based manufacturer Argentum Medical first had a version of its Silverlon contact wound dressing cleared by FDA in 1998, according to the agency's 510(k) database, for local management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions and dermal ulcers.
The most recently awarded indication follows work with HHS' Biomedical Advanced Research and Development Authority (BARDA) to demonstrate effectiveness of the device on patients harmed by mustard gas.
Sulfur mustard, more commonly known as mustard gas, was first used as a chemical weapon in World War I and has played a role in warfare up to and including the civil war in Syria. The ongoing use of mustard gas creates the risk that U.S. military personnel and civilians will be exposed to the chemical weapon and suffer serious injuries.
"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," BARDA director Rick Bright said in a statement Monday.
The medical countermeasure now available is a silver-plated nylon dressing. Argentum incorporated silver into the device for its antibiotic properties and designed it to last for one week, thereby sparing patients and caregivers the burden and pain of frequent dressing changes.
Since Silverlon's initial clearances, the dressing has been used in healthcare facilities and by first responders. The U.S. military has used the device to treat burn and blast wounds but lacked evidence to show it works against mustard gas injuries. BARDA stepped in to fill that evidence gap in 2013, part of an effort by the federal government to repurpose approved drugs and medical products for use in the event of an attack on the United States, according to the agency's statement.
The latest indication was supported by a test that assessed the effect of the device on minipigs with mustard gas injuries. The study found Silverlon is as good as the standard of care at treating moderate partial thickness depth mustard gas injuries when the dressing is changed every seven days. The study also showed the device is comparable to standard of care in the treatment of superficial thickness depth injuries when the dressing is changed every four days.
The clearance means BARDA, which stockpiles Silverlon in its burn countermeasure program, has a new way to protect the U.S., but there remain gaps in its defenses. BARDA's next focus in working with Argentum to amass the research necessary to support using Silverlon on patients with radiation burns.
In a separate announcement last week, BARDA said it awarded a two-year, $27.3 million contract to Dallas, Texas medtech SpectralMD to work on a new version of its burn imaging device, DeepView. The company is slated to conduct a five-center, expanded feasibility clinical trial aimed at developing an easily portable device.
BARDA noted experienced burn surgeons typically visually evaluate burn wounds to make treatment decisions, but the U.S. lacks enough of these professionals to evaluate the large scale of burn patients anticipated in the event of radiological or nuclear incident.
"The company is using advanced Artificial Intelligence (AI) algorithms to train the device’s software to analyze wounds at pixel level to determine tissue damage severity, burn depth and other physiological information well beyond human capability," BARDA shared in a statement.
BARDA said the contract has the potential to be extended for up to a total of four years and $91.1 million with the aim of supporting a 510(k) clearance.