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Medical Countermeasures Database

On This Page:
  1. Name of Chemical Defense therapeutic agent/device
  2. Chemical Defense therapeutic area
  3. Evidence-based medicine for Chemical Defense
  4. Pharmacokinetic and toxicokinetics data
  5. Indication/dosing
  6. Formulation/shelf life
  7. Off-label use & dosing
  8. Route of administrating/monitoring
  9. Adverse effects
  10. Contraindications
  11. Clinical studies in progress
  12. Non-clinical studies in progress
  13. Needed studies for Chemical Defense
  14. Needed studies for non-Chemical Defense
  15. Study-related ethical concerns
  16. Global regulatory status
  17. Other potentially useful information
  18. Publications
  19. Web sites

1. Name of Chemical Defense therapeutic agent/device

Argentum (Silverlon®)

2. Chemical Defense therapeutic area(s)

    — including key possible uses

2019: “First medical product cleared in U.S. for use on certain injuries caused by sulfur mustard. The U.S. government reached a milestone in its long-standing efforts to defend the country against potential use of chemical weapons: the first U.S. Food and Drug Administration (FDA) clearance of a product to manage certain blister injuries caused by sulfur mustard, commonly known as mustard gas.”

2019: “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.”

Over-the-Counter Indications (From Silverlon.com)

  • “Local management of superficial wounds, minor burns, abrasions and lacerations.”

  • “Prescription Indicators. Under the supervision of a healthcare professional Silverlon Island Wound Dressings and Silverlon Wound Pad Dressings are intended for up to 7 day use for wounds such as vascular access or peripheral IV sites, orthopedic external pin sites, wound drain sites, surgical wounds (donor and graft sites, incisions), and partial to full thickness dermal ulcers (stage I-IV pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers).”

  • “Silverlon Island Wound Dressings and Silverlon Wound Pad Dressings are indicated for the management of infected wounds, as the silver in the dressing provides an antimicrobial barrier that may be helpful in managing these wounds. In addition the moist wound healing environment and control of wound bacteria within the Silverlon Island Wound Dressing and Silverlon Wound Pad Dressing may help reduce the risk of wound infection and support the body’s healing process.”

  • “Silverlon Island Wound Dressings and Silverlon Wound Pad Dressings may be used for the management of painful wounds, Silverlon Island Wound Dressings and Silverlon Wound Pad Dressing’s non-adherent wound contact layer reduces pain during dressing changes and evaporation of moisture in the dressing may soothe the wound.”

3. Evidence-based medicine for Chemical Defense

    — including efficacy and safety

A. Summary

Structure

  • “Silverlon Island Wound Dressings and Silverlon Wound Pad Dressings are multi-layer, sterile, non-adherent, antimicrobial barrier wound dressings.”

Mechanism of action

  • Delivers antimicrobial Ag ions when activated by moisture.

  • “Through a unique silver plating process, Silverlon puts the antimicrobial power of pure silver in the dressing – more pure metallic silver than any other silver based dressing. When activated by moisture, it generates the silver ions that are effective against a wide spectrum of wound pathogens.”

  • “Silver ion has strong antimicrobial properties and is used in a number of wound dressings. In burn models, silver-nylon dressings produce elevated silver levels in the wound along with minimal systemic effect.”

    Barillo DJ, Croutch CR, Barillo AR, Reid F, Singer A. Safety evaluation of silver-ion dressings in a porcine model of deep dermal wounds: A GLP study. Toxicol Lett. 2020 Feb 1;319:111-118. Doi: 10.1016/j.toxlet.2019.10.023. Epub 2019 Nov 9. PMID: 31715245.

  • “Efficient Silver Release From Ion Exchange Silver Dressings in Biologically Relevant Media.”

    “The purpose of this study is to analyze the release of silver ions from wound dressings with different silver sources, including a dressing that utilizes ion exchange silver technology. The focus of this study will be on the kinetic release profile of each silver source in a medium that simulates proteinaceous wound fluid at a volume-to-surface area ratio corresponding to a heavily exuding wound over a period of several days. These analyses will enable a better understanding of the kinetics of release and the antimicrobial performance of ion exchange silver dressings during use. Materials. Dressings tested in this study represent several different formats and types of silver: 1 dressing containing ion exchange silver (Ag+ complex), 2 dressings containing ionic silver (Ag+), and 2 dressings containing metallic silver (Ag0) (Table 1). The descriptions and loadings of silver in the dressings have been reported in several publications,22-24 including product literature and brochures. TRITEC Silver (Ag+ complex dressing; Milliken Healthcare Products, Spartanburg, SC) is a bilayer contact dressing incorporating a silver ion-exchange compound (silver zirconium phosphate) with Active Fluid Management (Milliken Healthcare Products) technology. ACTICOAT 7 with SILCRYST Nanocrystals (Ag0 dressing A; Smith + Nephew, Fort Worth, TX) is a multilayer contact dressing in which the silver treatment is a physical vapor deposition process. Silverlon Surgical Dressing (Ag0 dressing B; Argentum Medical, Geneva, IL) contains a nylon electroplated with Ag0. 3M Tegaderm Ag Mesh Dressing with Silver (Ag+ dressing A; 3M, St Paul, MN) consists of silver sulfate deposited onto a nonwoven cotton fabric. AQUACEL Ag Dressing (Ag+ dressing B; ConvaTec Inc, Bridgewater, NJ) consists of silver chloride (sodium carboxymethylcellulose).

    Conclusions. In typical SWF, the silver ions released from most silver dressings peaked at Ca 0.5 ppm of soluble silver. Apparent equilibria established between silver ions and salts used for SWF (NaCl and CaCl2) were disrupted by the presence of protein (eg, BSA), resulting in a dramatic increase in silver ion release over ionic solutions with no protein. All tested dressings responded similarly to increasing concentrations of protein, regardless of the dressing format, form, nature of silver source, or initial silver content. It is clear from this study that organics, such as proteins, act to shift the equilibrium of soluble silver. Temperature does not seem to play a significant role in controlling the release of silver ions.

    Dressings differed dramatically in the efficiency of silver release. It is evident the nature of silver is more relevant to its release than the silver content of the dressings. The percentage of silver depleted from the dressings after exposure to clinically relevant amounts of exudate ranged from 100% (silver reservoir was depleted after only 1 day of exposure) to greater than or equal to 60% after 7 days. The Ag+ complex dressing was the most effective among all the dressings tested for silver ion release efficiency. Further studies will focus on the antimicrobial efficacy of released silver ions from different dressings and whether microbes themselves can act as a reservoir for silver ions.

    Mondal R, Foote M, Canada A, Wiencek M, Cowan ME, Acevedo C. Efficient Silver Release From Ion Exchange Silver Dressings in Biologically Relevant Media. Wounds. 2020 Jan;32(1):22-29. Epub 2019 Oct 31. PMID: 31730507.

  • 2006: “Silver as biocides in burn and wound dressings and bacterial resistance to silver compounds.”

    Abstract. Silver products have been used for thousands of years for their beneficial effects, often for hygiene and in more recent years as antimicrobials on wounds from burns, trauma, and diabetic ulcers. Silver sulfadiazine creams (Silvazine and Flamazine) are topical ointments that are marketed globally. In recent years, a range of wound dressings with slow-release Ag compounds have been introduced, including Acticoat, Actisorb Silver, Silverlon, and others. While these are generally accepted as useful for control of bacterial infections (and also against fungi and viruses), key issues remain, including importantly the relative efficacy of different silver products for wound and burn uses and the existence of microbes that are resistant to Ag+. These are beneficial products needing further study, although each has drawbacks. The genes (and proteins) involved in bacterial resistance to Ag have been defined and studied in recent years.

    Silver S, Phung le T, Silver G. Silver as biocides in burn and wound dressings and bacterial resistance to silver compounds. J Ind Microbiol Biotechnol. 2006 Jul;33(7):627-34. doi: 10.1007/s10295-006-0139-7. Epub 2006 May 25. PMID: 16761169.

Summary of clinical and non-clinical studies

  • “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.”

B. Link to clinical studies

  • From ClinicalTrials.gov

    Nine studies of Silverlon are included; however, none of them are about the treatment of mustard gas injury.

  • From Silverlon.com

    10/18/22 note from developer of this draft record: Although numerous publications are noted in the Silverlon.com web site below, none are focused on Silverlon and mustard gas injuries. Also, not all of the publications are clinical studies and not all of the publications mention Silverlon.

    “Multiple, peer-reviewed, published studies have shown the effect that Silverlon can have. Studies in a wide variety of Surgical, Wound and Burn Care settings. Explore the studies behind the most advanced, evidence-based antimicrobial dressings available today.”

    “Please note: These studies may involve findings that exceed the claims currently cleared by the FDA for the product. Argentum Medical, LLC is not intending to make performance claims about its product. The intent is to disseminate the scientific literature on these products. We encourage you to read these studies to understand the strengths and limitations of the data. For some claims, Argentum is seeking to broaden the indications with the FDA in the future using data, such as these studies, to provide the substantiation.”

Studies involving multiple populations

Adult

2018: “Is There an Optimal Wound Closure Technique for Major Posterior Spine Surgery? A Systematic Review.”

    Objectives: In patients undergoing posterior spinal fusion: (1) What are the types and risks of wound complications in major (≥3 levels) surgery, and does the risk vary by number of levels fused? (2) What types of fascial closure result in the fewest wound complications? (3) What subcutaneous closure technique is more effective in preventing wound complications for obese patients (body mass index >30 kg/m2)? (4) What type of skin closure results in the fewest wound complications? (5) What type of dressing results in the fewest wound complications?

    Methods: Electronic databases and reference lists of key articles were searched from January 1, 2000 to December 4, 2017 to identify studies meeting inclusion criteria.

    Results: Six lower quality retrospective studies (evidence level III) met the inclusion criteria. The risk of wound complications in patients with ≥3 level posterior spine fusion ranges from 1.5% to 3.7% depending on the definition of wound complications. Skin closure with sutures resulted in fewer wound infections compared with staples (0.0% vs 8.0%, P = .023). We were unable to demonstrate an association between the number of levels fused and infection risk. Wound infections, primarily superficial, occurred less frequently with Silverlon dressing versus routine dressing.

    Yilmaz E, Blecher R, Moisi M, Ankush C, O’Lynnger TM, Abdul-Jabbar A, Dettori JR, Oskouian RJ. Is There an Optimal Wound Closure Technique for Major Posterior Spine Surgery? A Systematic Review. Global Spine J. 2018 Aug;8(5):535-544. Doi: 10.1177/2192568218774323. Epub 2018 May 23. PMID: 30258761; PMCID: PMC6149048.

2018: “The Use of a Silver-Nylon Dressing During Evacuation of Military Burn Casualties.”

    Abstract. The military has used silver-nylon dressings as a topical antimicrobial on combat-related burns for the past 15 years. However, their clinical efficacy and associated risks have not been evaluated. Herein, the authors document our experience with the use of a specific silver-nylon dressing (Silverlon®) during global evacuation of casualties from combat zones to the United States sArmy Institute of Surgical Research Burn Center. A 10-year retrospective analysis was performed. Variables included patient demographics, total body surface area, length of stay, Injury Severity Score, incidence of urinary tract and burn infections, pneumonia, patient status at the time of discharge, and a composite endpoint. The patient cohort was stratified into two groups: Silverlon® (Group 1) and topical antimicrobial agents (Group 2). Data were analyzed using appropriate statistical tests (P ≤ .05). Nine hundred eighty-eight patients (26 ± 6 years) were identified with 184 patients (Group 1) and 804 patients (Group 2). Silver-nylon dressings trended toward decreased wound infection rate (5.4 vs 9.5%) even when applied to full-thickness burn injuries. When compared with topical antimicrobial agents, the silver-nylon dressing was not associated with significant differences in burn-related complication. The authors demonstrate the antimicrobial efficacy of the silver-nylon dressing during global evacuation of burn casualties from combat zones to the burn center. Compared with topical antimicrobials, the silver-nylon dressing is lightweight and easy to apply and requires minimal wound management which makes it desirable as a burn dressing for combat applications as well as mass casualty situations.

    Aurora A, Beasy A, Rizzo JA, Chung KK. The Use of a Silver-Nylon Dressing During Evacuation of Military Burn Casualties. J Burn Care Res. 2018 Jun 13;39(4):593-597. Doi: 10.1093/jbcr/irx026. PMID: 29901799.

2014: “Experience in treating combat burns in Afghanistan by using silver-nylon dressing.”

    Abstract

    Background: On the battlefield, insidious and devastating weapons like the improvised explosive device (IED) rapidly emit extreme heat (thousands of degrees), create a shock wave (overpressure) that can hurl bodies long distances (inducing secondary fall lesions), and deliver thousands of pieces of shrapnel over hundreds of meters.

    Materials and methods: Very often, Soldiers injured by an IED blast are inside their vehicle. Subsequently, they are exposed to the thermal effects of the blast. Frequently, these patients have complex wounds that consist of extensive burn areas, bone fractures, and internal organ lesions. The use of silver-nylon burn wrap dressing is widely documented for its bactericidal properties. Silverlon® Burn Dressings is an elastic bandage made of nylon and plated with pure metallic silver.

    Results: In summer 2008, in a U.S. advanced Role 2 facility, two U.S. Soldiers with extensive second- and third-degree burn injuries were successfully treated with the use of Silverlon Burn Dressings and Silverlon® Burn Gloves.

    Conclusions: From this experience emerged the ease of use silver-nylon dressing in treating badly burned Soldiers on the battlefield.

    Pozza M, Matthew P, Lunardi F. Experience in treating combat burns in Afghanistan by using silver-nylon dressing. J Spec Oper Med. 2014 Spring;14(1):1-5. Doi: 10.55460/4HMG-7SO2. PMID: 24604431.

Pediatric studies

Pregnancy, breast feeding studies

Geriatric

Clinical reviews

C. Link to non-clinical (e.g., animal) studies

Adult animal studies

2020: “Safety evaluation of silver-ion dressings in a porcine model of deep dermal wounds: A GLP study.”

    Methods (Methods text is from full text publication at: https://www.sciencedirect.com/science/article/abs/pii/S0378427419303479?via%3Dihub)

    Eight deep partial-thickness wounds each were created on the dorsum of 40 Gottingen minipigs using a Er-YAG Laser. Half were treated with a 21-day course of silver-nylon dressings (Silverlon®) and half were treated with moist gauze dressings. Wound, blood, liver and kidney silver levels, along with blood chemistry and hematology data were obtained at appropriate intervals.

    Results: All wounds healed well with healing enhanced by silver-nylon dressings. Silver ion was demonstrable in all wounds treated with silver-nylon at day 21 and after 14 days of no further treatment. Silver ion was not detected in blood, liver or kidney of any animal treated with silver-nylon or control dressings. Liver and kidney function remained normal in all animals.

    Conclusion: A 21-day application of silver-nylon dressings to a non-burn dermal wound produces no systemic or local toxicity in Gottingen minipigs.

    Barillo DJ, Croutch CR, Barillo AR, Reid F, Singer A. Safety evaluation of silver-ion dressings in a porcine model of deep dermal wounds: A GLP study. Toxicol Lett. 2020 Feb 1;319:111-118. Doi: 10.1016/j.toxlet.2019.10.023. Epub 2019 Nov 9. PMID: 31715245.

2020: “Cerium nitrate enhances anti-bacterial effects and imparts anti-inflammatory properties to silver dressings in a rat scald burn model.”

    Abstract. Current commercially available silver-based wound dressings such as silver-nylon have been used as antimicrobial barriers for burn and trauma care in combat conditions for over 10 years. However, these dressings do not stabilize the eschar or reduce its toxicity. Cerium nitrate (CN) solutions have been established clinically to stabilize the eschar by decreasing release of inflammatory mediators from burned tissue thereby allowing delayed excision and grafting. In this report, we tested the extent to which CN imparts CN benefits to silver dressings for temporizing treatments of burn wounds and enhancing anti-bacterial activity. Using a rat full-thickness scald burn model, we showed that CN enhanced the anti-bacterial effects of the tested silver-based dressings (Acticoat™, Mepilex™, and Silverlon®), while also imparting anti-inflammatory properties to these dressings. Compared to the use of silver dressings alone, CN significantly decreased the levels of IL-1β and GRO/KC, and exhibited downward trending levels of IL-1α, MIP-1α, and bacterial bioburden within the wound. Based on our findings, we conclude that CN has the ability to expand and enhance the function of several silver dressings. We propose the use of CN in combination with silver dressings to stabilize burn wounds thereby allowing postponement of excision and grafting, most notably in scenarios where the standard of care is not feasible such as in combat situations, resource limited regions, and new emergent health care challenges as seen during the COVID-19 pandemic in which COVID-positive severe burn patients are not able to undergo surgery during an active outbreak.

    Qian LW, Fourcaudot AB, Chen P, Brandenburg KS, Weaver AJ Jr, Leung KP. Cerium nitrate enhances anti-bacterial effects and imparts anti-inflammatory properties to silver dressings in a rat scald burn model. Int J Burns Trauma. 2020 Aug 15;10(4):91-100. PMID: 32934862; PMCID: PMC7486562.

2005: “Therapeutic efficacy of three silver dressings in an infected animal model.”

    Abstract. The organic salt AgNO3 has been available as a topical armamentarium to the medical arena for centuries and for burns for the past 60 years. Thirty-five (1968) years later, Charles Fox introduced and popularized a new topical agent known as silver sulfadiazine. More recently, several new slow-release silver dressings came to the forefront. Acticoat (Smith & Nephew, Largo, FL) Silverlon (Argentum, Lakemont, GA) & Silvasorb (Medline Industries, Inc, Mundelein, IL). Because the standard of care is to change dressings daily, our study focused in on weekly dressing changes as a cost-containment issue. Sprague-Dawley rats received a standard contact burn (20% TBSA). On day 3, the wound was excised and infected with Pseudomonas aeruginosa and Staphylococcus aureus at 5.0 x 10 cfu/ml. The animals were divided into four groups (n = 5 each group): untreated control, Acticoat group, Silvasorb group, and Silverlon group. The dressings remained on the wounds for 10 days when the wounds were quantitatively assessed. Mean wound counts of the control ranged from 1.2 x 10(5) to 6.5 x 10(5) for P. aeruginosa and S. aureus, respectively. Acticoat dressing counts for both organisms were 0 and 1.8 x 10(3) (median alpha); Silvasorb was 0 and 6.3 x 10(3) and Silverlon was 1.5 x 10(4) x 7.4 x 10(4) (median), Acticoat and Silvasorb were both significantly lower (P < .05) than the control for P. aeruginosa, and Acticoat was significantly lower (P < .05) than the control for S. aureus. Although counts for Silvasorb (M) appear significantly lower than the controls for S. aureus, the numbers were not sufficient to be significant. However, Silverlon did achieve a slight significance. These preliminary data suggest that weekly dressing changes with these new silver dressings are feasible and economically and medically congruous.

    Heggers J, Goodheart RE, Washington J, McCoy L, Carino E, Dang T, Edgar P, Maness C, Chinkes D. Therapeutic efficacy of three silver dressings in an infected animal model. J Burn Care Rehabil. 2005 Jan-Feb;26(1):53-6. Doi: 10.1097/01.bcr.0000150298.57472.26. PMID: 15640735.

Comparative human and animal in vitro studies

2017: “Cytotoxicity testing of burn wound dressings: first results.”

    Abstract. Topical antimicrobial therapy represents an essential part of burn wound care. In order to prevent and treat burn wound infection dressings with antimicrobial properties are applied directly on the wound surface. Not only the infection control but also promotion of healing is very important in burn wound management. It is well known, that a dressing in bactericidal concentration might also delay wound healing. This study was aimed to evaluate the potential toxic effect of topical antimicrobial agents on murine and human dermal cells. For toxicity testing the method by Vittekova et al. was used to evaluate potential toxic effects of 16 agents and 6 control samples on two in vitro cultured cell systems [3T3 cells and dermal fibroblasts] during the first 24 h. Following the 24 h cell culture with the tested agents the live cell counts were evaluated. According to results obtained on both cell systems, the tested samples were divided into three groups-nontoxic, semi-toxic and toxic. Nontoxic samples included Acetic acid 1%, Acticoat®, Dermacyn®, Framykoin®, Silverlon®, gauze, acellular human allodermis and acellular porcine xenodermis. Semi-toxic group included Algivon®Plus, Aquacel®Ag, Betadine®, Nitrofurazone, Octenisept®, Suprasorb® A and a porcine dermal scaffold Xeno-Impl. Finally, the toxic group included Algivon®, Dermazin®, Ialugen®Plus, Prontoderm®, Suprasorb® A Ag and 20% SDS. As the preliminary results of this study have shown, our findings may serve as a potential guide to selection of the most appropriate topical antimicrobial dressings for treatmet of burns. However before they can be translated into clinical practice recommendations, more research on antimicrobial dressings cytotoxicity testing will be necessary.

    Hajská M, Dragúňová J, Koller J. Cytotoxicity testing of burn wound dressings: first results. Cell Tissue Bank. 2017 Jun;18(2):143-151. Doi: 10.1007/s10561-017-9621-x. Epub 2017 Apr 7. PMID: 28389969.

2012: “Evaluation of silver-containing activated carbon fiber for wound healing study: In vitro and in vivo.”

    Abstract. Silver has antiseptic properties, anti-inflammatory properties, and is a broad-spectrum antibiotic for multidrug-resistant strains of bacteria. The commercially available product, Silverlon®, is a silver-plated three-dimensional polyamide fabric with a high silver concentration of 546 mg/100 cm(2). Thus, fibroblast cell growth is affected when exposed to the Silverlon® treated cell medium. Our study produced an activated carbon fiber wound dressing that incorporated various silver concentrations (in cooperation of Bio-Medical Carbon Technology) to examine antimicrobial properties and determine fibroblast cell viability upon exposure to the silver impregnated dressing material as compared to other commercially available products such as calcium alginate dressing, Sorbalgon®, and silver-polyamide fabric dressing, Silverlon®. The silver impregnated activated carbon fiber dressing induced less damage to fibroblast cells compared to the effect produced by Silverlon® and exhibited similar antibacterial abilities in vitro. An in vivo analysis showed that various silver concentrations impregnated activated carbon fiber dressings promoted tissue reconstruction for wound healing in rats with Pseudomonas aeruginosa infected wounds.

    Lin YH, Lin JH, Wang SH, Ko TH, Tseng GC. Evaluation of silver-containing activated carbon fiber for wound healing study: In vitro and in vivo. J Biomed Mater Res B Appl Biomater. 2012 Nov;100(8):2288-96. Doi: 10.1002/jbm.b.32800. Epub 2012 Sep 15. PMID: 22987792.

Animal in vitro studies

Non-clinical reviews

Other non-clinical studies

No data available at this time.

Non-clinical reviews

No data available at this time.

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4. Pharmacokinetic and toxicokinetics data

    — including children-, pregnancy-, geriatric-, and obesity-related data

Adult

Children

Pregnancy

Geriatric

Renal Impairment

Hepatic Impairment

Obesity

Animal

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5. Current FDA/EUA approved indications and dosing

    — including children-, pregnancy-, geriatric-, and obesity-related data, and Emergency Use Authorization (EUA)

  • See: https://www.silverlon.com/resources/fda-clearances

  • See:https://www.silverlon.com/newsroom/argentum-medical-announces-510k-clearance-of-silverlon-burn-and-wound-care-products-for-vapor-sulfur-mustard-indication

  • “For chemical nerve agent and burn care preparedness, FDA expanded the indication for Silverlon, a first-of-its-kind wound contact dressing to include management of certain injuries caused by exposure to sulfur mustard vapor, commonly known as mustard gas. The Biomedical Advanced Research and Development Authority (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 mustard.” For more information, see the HHS news release, First medical product cleared in U.S. for use on certain injuries caused by sulfur mustard, available at:

    https://www.phe.gov/Preparedness/news/Pages/FDA-blister-injuries.aspx
    and
    https://www.fda.gov/media/136121/download

  • 2019: “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.”

Adult (FDA)

Children (FDA)

Pregnancy (FDA)

Nursing Mothers (FDA)

Geriatric (FDA)

Renal Impairment (FDA)

Hepatic Impairment (FDA)

Emergency Use Authorization (FDA/CDC)

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6. Current available formulations/shelf life

Formulation

    Silverlon® dressings are sterile, porous, non-adherent, knitted nylon plated with 99% elemental silver and 1% silver oxide). Deliver antimicrobial Ag ions when activated by moisture.

Shelf life

    5-year shelf life.

Stability

    7-day use indication.

    “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.”

SLEP (DOD/FDA)

    Storage

 

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7. Current off label utilization and dosing

    — including children-, pregnancy-, geriatric-, and obesity-related data

Adult

Children

Pregnancy

Geriatric

Obesity

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8. Route of Administration/Monitoring

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9. Adverse effects

 

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10. Contraindication(s)

  • Silverlon® Dressings should not be used on patients with 3rd degree burns or with known sensitivity to silver or nylon. For complete Instructions for Use: Instructions for Use”

11. Clinical studies in progress

    — including relevant ones and any others highlighting possible adverse effects and other effects/issues

No data available at this time.

 

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12. Non-clinical studies in progress

    — including relevant ones and any others highlighting possible adverse effects and other effects/issues

No data available at this time.

 

13. Needed studies for Chemical Defense clinical indication

    — including pharmacokinetics, safety, efficacy, pregnancy, breastfeeding, and review panel recommendations

No data available at this time.

 

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14. Needed studies for non Chemical Defense clinical indications

    — including review panel recommendations

No data available at this time.

 

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15. Study-related ethical concerns

    — including review panel recommendations

No data available at this time.

 

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16. Global regulatory status

US

From Silverlon.com:

https://www.silverlon.com/resources/fda-clearances

  • Silverlon has been marketed since 2000 with (14) different 510(k) premarketing clearances.
  • U.S. Military has used Silverlon since 2003 for burn and traumatic wounds.

E.U.

U.K.

Other

 

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17. Other potentially useful information

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18. Publications

PubMed search of “Silverlon”

https://pubmed.ncbi.nlm.nih.gov/?term=Silverlon

PubMed Collection as of 10/18/22 (n=20): https://www.ncbi.nlm.nih.gov/sites/myncbi/pertti.hakkinen.1/collections/62231988/public/

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19. Web sites



Record last updated 10/30/2024