Background

The prevention or resolution of microbial colonization of pathogenic microorganisms has and continues to have significant repercussions in the Health Care Industry. The use and misuse of antimicrobial agents continues to support the evolution of multi-drug resistant organisms that have the potential of causing significant morbidity and mortality. Medical Molecular Therapeutics has launched a new topical antimicrobial potentiated silver wound management product sold under the name Silvacide™. Silvacide™ has demonstrated in vitro, broad spectrum topical antimicrobial activity that not only inhibits but is bactericidal to the major multi-drug resistant organisms: methicillin resistant Staphylococcus aureus (MRSA), vancomycin resistant Entercoccus faecalis (VRE) and multi-drug resistant Pseudomonas aeruginosa. The potentiated action of Silvacide™ has demonstrated in vitro capability of disrupting the biofilms that bacteria secrete for protection. In addition, Silvacide™ has been demonstrated to have significant antifungal activity. The Silvacide™ is formulated with a pH to encourage the normal skin pH that ranges between 5.0 and 5.5.

Silvacide™

Silvacide™ has demonstrated:

• Broad spectrum antimicrobial coverage including multidrug resistant bacteria. methicillin-resistant Staphylococcus aureus (MRSA), and vancomycin-resistant Enterococcus faecalis (VRE), and Pseudomonas aeruginosa.
• Effectiveness against the gram positive and gram negative bacterial pathogens that cause nosocomial (hospital acquired) infections.
• Enhanced rate of wound healing.
• Dissolution and rendering ineffective bacteria generated biofilms
• Low probability of developing microbial resistance
• Biocompatable and non-cytotoxic

Silvacide™ Mode of Action

The potentiator component of Silvacide™ has demonstrated the ability to create holes in the bacterial cell walls, reducing the effectiveness of the bacteria’s efflux pump and facilitating osmotic collapse of the bacterium. In addition, the potentiator component of Silvacide™ has demonstrated the ability to create holes in biofilms. Alteration in membrane structure has enhanced the antimicrobial action of silver.

Pseudomonas sp. before and after exposure to the Silvacide™ potentiator. Normal “Intact” Cell Wall Before Exposure (left) Silvacide™ Potentiator Induced Cytoplasmic Leakage (right)

Cytotoxicity and Biocompatability Testing ISO Standards Silvacide™

Silvacide™ has met the requirements of the ISO regulatory standards in the “Cytotoxicity Study Using The Agarose Overlay Method” by NAMSA Lab No. 05T 35750 04 ID # 040105. Silvacide™ Wound Moisturizing Solution was found to be biocompatible by NAMSA in the following three biocompatability tests: (1) ISO Modified Intracutaneous Study Lab No 05T 32961 05 ID # 040105, (2) USP and ISO Modified Systemic Toxicity Study Lab No 05T 35750 02 ID #040105, and (3) ISO Maximization Sensitization Study Lab No 05T 32961 08 ID# 040105. All NAMSA documentation is available upon request.

Antimicrobial Testing: Minimal Inhibitory (MIC) and Minimal Bactericidal Concentrations (MBC) Silvacide™

Microtiter MIC and plate count MBC testing procedures were used according to the NCCLS, M31-A, 1999 standard. Serial 2-fold dilutions were made and inoculated with the test organism (concentration at 10E6 colony forming units per ml) followed by incubation at 35C. Antibiotic resistance profiles of Staphylococcus aureus, Pseudomonas aeruginosa, and Enterococcus faecalis isolated from human burn patients used for testing is presented in the following table.

Multi Drug Resistant Bacteria and Antimicrobial Agents

Organisms

Am

C

Cip

E

GM

K

NA

N

Ox

S

G

Te

Va

S. aureus

RB

I

R

R

S

R

R

R

R

S

S

S

S

P. aeruginosa

R

R

I

R

I

R

R

R

R

R

R

R

R

E. Faecalis

S

R

R

R

R

R

R

R

R

R

R

R

R

Am= ampicillin; C= chloramphenicol; Cip= ciprofloxacin; E= erythromycin; K= kanamycin; GM= gentamicin; NA= nalidixic acid; N= neomycin; Ox= oxacillin/methicillin; S=streptomycin; G= sulfisoxazole; Te= tetracycline; Va= vancomycin. B R= resistant; I= intermediate; S= sensitive.

MIC and MBC data for of Silvacide™ inoculated with 10E6 colony forming units per ml with the above referenced Pseudomonas aeruginosa, Enterococcus faecalis, and Staphylococcus aureus isolated from a human burn patients. Escherichia coli isolated from a dog with otitis externa. The “x” represents the starting concentration of Silvacide.

MIC and MBC Dilutions of Silvacide

	P. aeruginosa		S. Aureus		E. faecalis		E. coli
	MIC	MBC	MIC	MBC	MIC	MBC	MIC	MBC
Silvacide	0.25x	0.25x	0.25x	0.5x	0.25x	>0.5x	0.25x	0.5x

The above inhibitory and bactericidal concentrations of Silvacide clearly demonstrates the significant antimicrobial activity of Silvacide™.

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Vital Ionics, Inc. is an Advanced Wound Care Products Distributor. We service customers throughout Florida, and we service customers Nationwide.