Manejo médico · CHEMM

Material para profissionais de saúde e de resposta a emergências.

Tradução referenciada das diretrizes públicas do CHEMM (Chemical Hazards Emergency Medical Management, HHS/ASPR — governo dos EUA). Não é diagnóstico nem prescrição deste portal; doses e nomes de fármacos permanecem como na fonte original, com o link ao lado — confira sempre no original antes de qualquer conduta. As recomendações da fonte não se destinam a uso médico-legal.

Tradução não oficial, feita por este portal e sem endosso, revisão ou vínculo do HHS/ASPR nem do governo dos EUA. O material de origem é de domínio público; a responsabilidade por esta versão em português é do Produtos Perigosos.

☎ 0800 722 6001 — Disque-Intoxicação (CIATox, 24h)

Traduzido de Silverlon - Medical Countermeasures Database ↗ (CHEMM, HHS/ASPR — domínio público), fonte capturada em 2026-08-25. Em caso de dúvida, vale o original.

Silverlon — banco de contramedidas médicas

Name of Chemical Defense therapeutic agent/deviceno original (inglês)
Chemical Defense therapeutic areano original (inglês)
Evidence-based medicine for Chemical Defenseno original (inglês)
Pharmacokinetic and toxicokinetics datano original (inglês)
Indication/dosingno original (inglês)
Formulation/shelf lifeno original (inglês)
Off-label use & dosingno original (inglês)
Route of administrating/monitoringno original (inglês)
Adverse effectsno original (inglês)
Contraindicationsno original (inglês)
Clinical studies in progressno original (inglês)
Non-clinical studies in progressno original (inglês)
Needed studies for Chemical Defenseno original (inglês)
Needed studies for non-Chemical Defenseno original (inglês)
Study-related ethical concernsno original (inglês)
Global regulatory statusno original (inglês)
Other potentially useful informationno original (inglês)
Publicationsno original (inglês)
Web sitesno original (inglês)

1. Nome do agente terapêutico/dispositivo de defesa química

Argentum (Silverlon®)dose/fármaco conforme a fonte ↗

2. Área(s) terapêutica(s) de defesa química

2019: “Primeiro produto médico liberado nos EUA para uso em certas lesões causadas pela mostarda sulfurada. O governo dos EUA alcançou um marco em seus esforços de longa data para defender o país do possível uso de armas químicas: a primeira liberação, pela U.S. Food and Drug Administration (FDA), de um produto para o manejo de certas lesões bolhosas causadas pela mostarda sulfurada, comumente conhecida como gás mostarda.”

2019: “A FDA liberou um curativo para uso no tratamento de bolhas causadas pelo gás mostarda. O Departamento de Saúde e Serviços Humanos destacou a liberação, na segunda-feira, como um importante primeiro produto do gênero no enfrentamento de possíveis ataques com arma química.”

Indicações de venda livre (do Silverlon.com): “Manejo local de feridas superficiais, queimaduras leves, escoriações e lacerações.”dose/fármaco conforme a fonte ↗

“Indicadores sob prescrição. Sob supervisão de profissional de saúde, os Silverlon Island Wound Dressings e os Silverlon Wound Pad Dressings destinam-se a uso por até 7 day (7 dias) em feridas como sítios de acesso vascular ou de acesso venoso periférico, sítios de pinos externos ortopédicos, sítios de dreno de ferida, feridas cirúrgicas (áreas doadoras e de enxerto, incisões) e úlceras dérmicas de espessura parcial a total (escaras de estágio I-IV, úlceras de estase venosa, úlceras arteriais, úlceras diabéticas).”dose/fármaco conforme a fonte ↗
“Os Silverlon Island Wound Dressings e os Silverlon Wound Pad Dressings são indicados para o manejo de feridas infectadas, pois a prata do curativo fornece uma barreira antimicrobiana que pode ser útil no manejo dessas feridas. Além disso, o ambiente úmido de cicatrização e o controle das bactérias da ferida dentro do Silverlon Island Wound Dressing e do Silverlon Wound Pad Dressing podem ajudar a reduzir o risco de infecção da ferida e apoiar o processo de cicatrização do corpo.”dose/fármaco conforme a fonte ↗
“Os Silverlon Island Wound Dressings e os Silverlon Wound Pad Dressings podem ser usados no manejo de feridas dolorosas; a camada de contato não aderente do Silverlon Island Wound Dressing e do Silverlon Wound Pad Dressing reduz a dor durante as trocas de curativo, e a evaporação da umidade do curativo pode aliviar a ferida.”dose/fármaco conforme a fonte ↗

3. Medicina baseada em evidência para defesa química

A. Resumo

Estrutura

“Os Silverlon Island Wound Dressings e os Silverlon Wound Pad Dressings são curativos multicamadas, estéreis, não aderentes, com barreira antimicrobiana.”dose/fármaco conforme a fonte ↗

Mecanismo de ação

Libera íons antimicrobianos de Ag quando ativado pela umidade.

“Por um processo exclusivo de prateamento, o Silverlon coloca no curativo o poder antimicrobiano da prata pura — mais prata metálica pura do que qualquer outro curativo à base de prata. Quando ativado pela umidade, gera os íons de prata eficazes contra amplo espectro de patógenos de ferida.”dose/fármaco conforme a fonte ↗
“O íon prata tem fortes propriedades antimicrobianas e é usado em vários curativos. Em modelos de queimadura, os curativos de prata-náilon produzem níveis elevados de prata na ferida com efeito sistêmico mínimo.” 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 (Ag 0 ) ( 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 (Ag 0 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 (Ag 0 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 CaCl 2 ) 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.dose/fármaco conforme a fonte ↗no original (inglês)
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.dose/fármaco conforme a fonte ↗no original (inglês)

Resumo dos estudos clínicos e não clínicos

“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.”dose/fármaco conforme a fonte ↗no original (inglês)

B. Link para os estudos clínicos

From ClinicalTrials.gov Nine studies of Silverlon are included; however, none of them are about the treatment of mustard gas injury.dose/fármaco conforme a fonte ↗no original (inglês)
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.”dose/fármaco conforme a fonte ↗no original (inglês)

Studies involving multiple populationsno original (inglês)

Adulto

2018: “Is There an Optimal Wound Closure Technique for Major Posterior Spine Surgery? A Systematic Review.”no original (inglês)

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?dose/fármaco conforme a fonte ↗no original (inglês)

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.no original (inglês)

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.dose/fármaco conforme a fonte ↗no original (inglês)

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.no original (inglês)

2018: “The Use of a Silver-Nylon Dressing During Evacuation of Military Burn Casualties.”no original (inglês)

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.dose/fármaco conforme a fonte ↗no original (inglês)

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.no original (inglês)

2014: “Experience in treating combat burns in Afghanistan by using silver-nylon dressing.”no original (inglês)

Abstractno original (inglês)

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.no original (inglês)

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.dose/fármaco conforme a fonte ↗no original (inglês)

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.dose/fármaco conforme a fonte ↗no original (inglês)

Conclusions: From this experience emerged the ease of use silver-nylon dressing in treating badly burned Soldiers on the battlefield.no original (inglês)

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.no original (inglês)

Estudos pediátricos

Pregnancy, breast feeding studies Geriatric Clinical reviewsno original (inglês)

C. Link para os estudos não clínicos (por exemplo, em animais)

Estudos em animais adultos

2020: “Safety evaluation of silver-ion dressings in a porcine model of deep dermal wounds: A GLP study.”no original (inglês)

Methods (Methods text is from full text publication at: https://www.sciencedirect.com/science/article/abs/pii/S0378427419303479?via%3Dihub )no original (inglês)

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.dose/fármaco conforme a fonte ↗no original (inglês)

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.no original (inglês)

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

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.no original (inglês)

2020: “Cerium nitrate enhances anti-bacterial effects and imparts anti-inflammatory properties to silver dressings in a rat scald burn model.”no original (inglês)

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.dose/fármaco conforme a fonte ↗no original (inglês)

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.no original (inglês)

2005: “Therapeutic efficacy of three silver dressings in an infected animal model.”no original (inglês)

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.dose/fármaco conforme a fonte ↗no original (inglês)

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.no original (inglês)

Estudos in vitro comparativos, humanos e animais

2017: “Cytotoxicity testing of burn wound dressings: first results.”no original (inglês)

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.dose/fármaco conforme a fonte ↗no original (inglês)

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.no original (inglês)

2012: “Evaluation of silver-containing activated carbon fiber for wound healing study: In vitro and in vivo.”no original (inglês)

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.dose/fármaco conforme a fonte ↗no original (inglês)

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.no original (inglês)

Animal in vitro studiesno original (inglês)

Non-clinical reviewsno original (inglês)

Outros estudos não clínicos

No data available at this time.no original (inglês)

Revisões não clínicas

No data available at this time.no original (inglês)

4. Dados farmacocinéticos e toxicocinéticos

Adulto

Crianças

Gravidez

Idosos

Insuficiência renal

Insuficiência hepática

Obesidade

Animais

5. Indicações e posologia atualmente aprovadas pela FDA/EUA

Veja: https://www.silverlon.com/resources/fda-clearancesdose/fármaco conforme a fonte ↗
Veja: https://www.silverlon.com/newsroom/argentum-medical-announces-510k-clearance-of-silverlon-burn-and-wound-care-products-for-vapor-sulfur-mustard-indicationdose/fármaco conforme a fonte ↗
“Para a preparação contra agente nervoso químico e para o cuidado de queimaduras, a FDA ampliou a indicação do Silverlon, um curativo de contato inédito, para incluir o manejo de certas lesões causadas pela exposição ao vapor de mostarda sulfurada, comumente conhecida como gás mostarda. A Biomedical Advanced Research and Development Authority (BARDA) forneceu conhecimento técnico e financiamento para apoiar os estudos necessários para demonstrar que o produto, Silverlon, é apropriado para uso em queimaduras cutâneas de primeiro e segundo graus causadas pela exposição à mostarda sulfurada.” Para mais informações, veja o comunicado do HHS, First medical product cleared in U.S. for use on certain injuries caused by sulfur mustard, disponível em: https://www.fda.gov/media/136121/downloaddose/fármaco conforme a fonte ↗
2019: “A FDA liberou um curativo para uso no tratamento de bolhas causadas pelo gás mostarda. O Departamento de Saúde e Serviços Humanos destacou a liberação, na segunda-feira, como um importante primeiro produto do gênero no enfrentamento de possíveis ataques com arma química. A fabricante Argentum Medical, de Geneva, Illinois, teve uma versão de seu curativo de contato Silverlon liberada pela primeira vez pela FDA em 1998, segundo o banco de dados 510(k) da agência, para o manejo local de queimaduras de espessura parcial, incisões, enxertos de pele, áreas doadoras, lacerações, escoriações e úlceras dérmicas. A indicação mais recente decorre do trabalho com a Biomedical Advanced Research and Development Authority (BARDA) do HHS, para demonstrar a eficácia do dispositivo em pacientes lesados por gás mostarda.”dose/fármaco conforme a fonte ↗

Adulto (FDA)

Carta 510(k) da U.S. FDA de 18 de julho de 2019: https://www.accessdata.fda.gov/cdrh_docs/pdf19/K190343.pdf

Crianças (FDA)

Gravidez (FDA)

Lactantes (FDA)

Idosos (FDA)

Insuficiência renal (FDA)

Insuficiência hepática (FDA)

Autorização de uso emergencial (FDA/CDC)

6. Formulações disponíveis atualmente / prazo de validade

Formulação

Os curativos Silverlon® são de náilon tricotado, estéril, poroso e não aderente, revestido com 99% de prata elementar e 1% de óxido de prata. Liberam íons antimicrobianos de Ag quando ativados pela umidade.dose/fármaco conforme a fonte ↗

Prazo de validade

Prazo de validade de 5-year (5 anos).

Estabilidade

Indicação de uso por 7-day (7 dias).

“A contramedida médica agora disponível é um curativo de náilon revestido de prata. A Argentum incorporou a prata ao dispositivo por suas propriedades antibióticas e o projetou para durar uma semana, poupando pacientes e cuidadores do peso e da dor das trocas frequentes de curativo.”

SLEP (DOD/FDA)no original (inglês)

Armazenamento

7. Utilização e posologia off-label atuais

Adulto

Crianças

Gravidez

Idosos

Obesidade

8. Via de administração / monitorização