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Literature Review:
Clinical Information Relating to the Development of SureSkin® Silver Hydrocolloid Dressing and SureSkin® Silver (OTC) Bandage
Laura Bolton, PhD, Adjunct Associate Professor, Department of Surgery (Bioengineering)
University of Medicine and Dentistry of New Jersey and President, Bolton SCI, LLC
ABSTRACT
A review of the available literature identified clinical evidence supporting efficacy and safety of silver-containing dressings on clinical wounds. Eight prospective randomized controlled trials (RCTs) support a conclusion of improved chronic wound outcomes when dressed with silver dressings. These studies reported significant (p< 0.05) improvements in the following outcomes for chronic and acute wounds dressed for 2 to 12 weeks with silver dressings compared to non-silver gauze, foam, alginate or other best non-silver practice:
- percent of wounds healed (1 study on venous ulcers),
- reduction in wound area (3 studies on pressure, venous or mixed etiology ulcers)
- ulcer depth reduction (2 studies on diabetic foot ulcers),
- reduced slough or maceration (1 study on diabetic foot ulcers)
- reduced wound severity (1 study on mixed chronic wounds) or
- reduced bacterial burden (1 study on chronic wounds of unspecified etiology)
- less wound-related pain, trauma and time to change dressings (2 studies on acute wounds)
In addition to the above RCTs, 17 uncontrolled studies using silver-containing dressings on more than 462 chronic or acute wounds support silver wound dressing safety, but not efficacy.
Two RCTs on a total of 26 pressure ulcers, 215 venous ulcers and 26 diabetic ulcers studied Contreet® Foam dressings containing silver zeolite the active entity of which is silver ion. This silver zeolite material is the same entity used in SureSkin® Silver Hydrocolloid Dressing. Although Contreet® Foam and SureSkin® Silver Hydrocolloid Dressing differ in “base” formula, the former being a foam dressing and the latter a hydrocolloid, effects of the silver component are expected to be similar in both formulations. The relative merits of foam versus hydrocolloid would be related to the amount of wound exudate one dressing could handle versus the other. Generally foams are able to absorb more fluid than hydrocolloid adhesives over a short period while hydrocolloids generally form a more intimate adherent skin-adhesive seal, maintaining a moist wound environment more consistently than foam dressings (Bolton, Monte & Pirone, 2000).
Based on the information provided here, the microbiological effectiveness reported elsewhere in the dossier for SureSkin® Silver Hydrocolloid Dressing, and the microbiological effectiveness, biocompatibility, and absence of adverse effects reported in the literature for similar wound dressings releasing bactericidal levels of silver ion, it is concluded that SureSkin® Silver Hydrocolloid Dressing is safe and effective for its intended use.
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