Safety Evaluation of a New Ionic Silver Dressing in the Management of Chronic Ulcers

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Author(s): 
Wolfgang Vanscheidt, MD;[1] Isabelle Lazareth, MD;[2] Colette Routkovsky-Norval, MD[3]

Disclosure: This study was financially supported by ConvaTec, a Bristol-Myers Squibb Co., Princeton, New Jersey.

Introduction

The management of chronic wounds represents a significant burden, not only in terms of direct costs to healthcare services[1,2] but also in terms of pain, economic loss, and impaired quality of life experienced by patients. Any open wound is at risk of infection with potentially pathogenic organisms,[3–7] which may delay the healing process with resultant increases in trauma to the patient and burden of wound care. Prevention of infection has driven the development of occlusive wound dressings since the 1960s, and a variety of dressings, such as hydrocolloids, polyurethane films, and foams, are now available. The primary purpose of these dressings is to support wound healing by maintaining an optimal moisture balance while presenting a barrier to colonization by potential pathogens.[8–10]

While systemic antibiotics are essential components of the management of nonhealing infected wounds, debate ensues over the role of systemic and topical agents in the treatment of nonhealing, noninfected wounds.[11] Other nonmicrobiological solutions need to be considered as part of the multidisciplinary management of chronic wounds.

The dressing used in this safety evaluation is composed of sodium carboxymethylcellulose fibers (SCF) and has been available, without ionic silver, for clinical use since the mid-1990s (Aquacel®, ConvaTec, A Bristol-Myers Squibb Co., Princeton, New Jersey). The dressing fibers absorb wound exudate by vertical wicking and form a cohesive gel as they swell. The gel matrix molds itself over the wound surface, eliminating dead space and maintaining an optimal moist wound healing environment. The SCF dressing has also been shown to immobilize exudate containing bacteria and polymorphonuclear leukocytes within the dressing.[12] There is now considerable clinical experience with the SCF dressing,[13–18] and it is also associated with increased caregiver and patient benefits in terms of ease of application and removal and reduction in pain at dressing change.[17]

Silver has been used widely for many years in wound care to help manage local infection.[19–22] It has been incorporated into a variety of topical creams and solutions, as well as dressings, and exerts its antiseptic action by inhibiting bacterial enzymes associated with respiration. The principal dose-limiting effect for silver in humans is argyria, an irreversible discoloration of the skin and mucous membranes that is associated with systemic consumption and is considered cosmetically disfiguring rather than toxic per se.[20] However, very high systemic doses of silver are required to result in argyria, and it is very unlikely that exposure to topical silver in dressings used for chronic wounds carries any significant risk.

Currently available silver-containing dressings all utilize different technologies to make silver available in the dressing and at the wound dressing interphase. Not all silver dressings, however, provide the benefits of moist wound healing.[23,24] Ionic silver has been incorporated into the SCF dressing (Aquacel® Ag) without affecting its physical performance characteristics at a concentration effective against wound pathogens in vitro. The principle inherent in the ionic silver dressing is that silver ions released from the fibers are available to act on the bacteria trapped by the SCF dressing. This principle is intended to help maintain a low bioburden within the dressing and to assist in creating an antimicrobial barrier.

References: 

References

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