The Effectiveness of Silver-Releasing Dressings in The Management of Non-Healing Chronic Wounds: A Meta-Analysis

J Clin Nurs. 2009 Mar;18(5):716-28. doi: 10.1111/j.1365-2702.2008.02534.x.
The effectiveness of silver-releasing dressings in the

management of non-healing chronic wounds: a meta-
analysis.
Lo SF, Chang CJ, Hu WY, Hayter M, Chang YT.
Source
Department of Nursing, Tzu Chi College of Technology, Taipei, Taiwan.
Abstract
AIM:
The purpose of this study was to examine the efficacy of silver-releasing dressings in the
management of non-healing chronic wounds.
BACKGROUND:
Non-healing chronic wounds often have a negative physical impact on patients and place a
financial burden on healthcare systems. Silver dressings are wound products designed to
control infection and provide a wound environment conducive to healing. However, validation
of the clinical efficacy of these dressings is lacking.
DESIGN:
Systematic review and meta-analysis.
METHODS:
A systematic search of the major electronic databases PubMed, CINAHL, Cochrane,
MEDLINE, British Nursing Index, EBSCO, OCLC and Proquest between 1950-June 2007 was
conducted. Hand searches of selected periodicals, textbooks and checking reference lists and
contacting experts was also performed.
RESULTS:
Eight studies were selected from a potentially relevant 1957 references screened. Analysis
incorporated data from 1399 participants in the eight randomised control trials. We found that
silver dressings significantly improved wound healing (CI(95): 0.16-0.39, p < 0.001), reduced
odour (CI(95): 0.24-0.52, p < 0.001) and pain-related symptoms (CI(95): 0.18-0.47, p <
0.001), decreased wound exudates (CI(95): 0.17-0.44, p < 0.001) and had a prolonged
dressing wear time (CI(95): 0.19-0.48, p = 0.028) when compared with alternative wound
management approaches. An analysis of sensitivity in these studies by subgroup analysis
generally supported these associations. Furthermore, studies indicated an improvement in
quality of life (CI(95): 0.04-0.33, p = 0.013) using silver dressings in wound management with
no associated severe adverse events.
CONCLUSION:
This meta-analysis confirms the effectiveness of silver dressings in wound healing and
improving patients' quality of life. However, it also highlights the need for additional well-
designed randomised controlled trials to evaluate the effectiveness of silver-related dressings
further.
RELEVANCE TO CLINICAL PRACTICE:
The results of this study provide objective data on the effectiveness of silver-related dressing
when applied to non-healing chronic wounds.
Perspective: Silver on Non-Healing Chronic Ulcers
 6/9/2011
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Author(s):
Laura Bolton, PhD, FAPWCA
Dear Readers:
Recent reviews find insufficient evidence to recommend the use of silver-containing dressings or
topical agents (SIR) to prevent wound infection or to heal infected or contaminated chronic wounds. 1–
3 Lack of healing outcomes is counterbalanced by growing evidence supporting favorable outcomes of
SIR use on dynamic parameters, such as rate of chronic wound area 4 or depth5 reduction, and patient-
oriented outcomes, such as reduction of leakage and odor.4 We review a randomized controlled trial
(RCT) that reports a 4-week advantage for SIR on biofilm-contaminated wounds and a meta-analysis of
RCTs on non-healing chronic wounds citing positive SIR effects on healing rates and patient-oriented
outcomes. What can one do when systematic reviews and meta-analyses disagree about efficacy? This
Evidence Corner will look deeper into clinical study design issues that may obscure SIR effects. It is
time to sort out facts from artifacts and conduct the rigorous RCTs needed to explore the value topical
SIR may add in managing chronic ulcers at risk of infection.

Adjunct Associate Professor
Department of Surgery, UMDNJ
WOUNDS Editorial Advisory Board Member and Department Editor
Pressure and Venous Ulcers

Reference: Beele H, Meuleneire F, Nahuys M, Percival SL. A prospective randomised open label study
to evaluate the potential of a new silver alginate/carboxymethylcellulose antimicrobial wound dressing to
promote wound healing. Int Wound J. 2010;(4):262–270.
Rationale: Chronic wounds that form surface biofilms may be at risk of wound infection or of delayed
healing. Topical SIR may reduce wound surface colonization and lower that risk.
Objective: Compare infection prevention and progression to healing effects of an ionic silver
alginate/carboxymethylcellulose (SACMC) dressing with those of a non-silver calcium alginate fiber (AF)
dressing in patients with critically colonized (biofilm-infected) chronic pressure and venous leg ulcers.
Methods: Thirty-six patients with venous (n = 24) or pressure ulcers (n = 12) clinically judged as at risk
of infection based on the presence of wound biofilm and a modified ASEPSIS wound score were
randomly assigned to be primarily dressed for 4 weeks with either a silver SACMC or AF. All subjects
received appropriate compression or pressure redistribution. Primary outcomes measured during the 4
weeks of treatment were prevention of progression from “critical colonization” to infection measured
clinically using the modified ASEPSIS score, prevention of wound deterioration and progression to
wound healing, measured as reduction in wound surface area.
Results: SACMC subjects experienced a faster rate of surface area reduction than AF subjects during
the 4-week study (P = 0.017). Wound deterioration was reported in 1.5% of assessments for the
SACMC group and 13% of for the AF group. More wounds progressed from critical colonization to
clinical infection in the AF group (P = 0.013).
Authors’ Conclusions: SACMC dressing use was associated with fewer infections and faster area
reduction than AF dressing use.
Non-healing Chronic Wounds

Reference: Lo SF, Chang CJ, Hu WY, Hayter M, Chang YT. The effectiveness of silver-releasing
dressings in the management of non-healing chronic wounds: a meta-analysis. J Clin Nurs.
2009;18(5):716–728.
Rationale: Non-healing chronic wounds add to the financial burden of health care. Clinical evidence has
been reviewed for effects of silver dressings on infected or contaminated chronic wounds but not for
their use on non-healing chronic wounds.
Author(s):
Objective: This study explored the clinical evidence supporting use of silver primary dressings on
chronic non-healing wounds.
Methods: A systematic review and meta-analysis of RCT evidence explored effects of silver dressings
on non-healing chronic wounds. PubMed, CINAHL, Cochrane, MEDLINE, British Nursing Index,
EBSCO, OCLC, and Proquest reference databases were searched between 1950 and June 2007 for
related subjects. These searches were supplemented by hand searches and contact with experts.
Results: Eight qualifying RCTs on 1399 participants were selected for analysis. Significant evidence
supported SIR effects in improving aspects of wound healing, reduced odor, pain, and exudate (all
at P < 0.001). SIR primary dressings also prolonged dressing wear (P = 0.028) and improved quality of
life (P = 0.013) without associated adverse events.
Authors’ Conclusions: This meta-analysis confirms healing effectiveness of silver dressings in chronic
non-healing wounds and improving patients’ quality of life. More well-designed RCTs are needed to
evaluate these effects.
Clinical Perspective
The studies reviewed provide a counterpoint to reviews citing lack of evidence, 1–3 which does not
necessarily mean “lack of efficacy.” All effects reported are compelling because they studied appropriate
subjects and measured relevant outcomes. SACMC dressing should ideally have been compared to an
identical CMC control dressing without the silver alginate to prove that the significant effects reported in
this small study were caused by silver alone.
It is generally agreed that more rigorous RCTs are needed to conclude that SIR add value to chronic
wound management. One such RCT, the VULCAN trial,7 which has been critiqued elsewhere,8 may
have missed important SIR effects by reporting complete healing effects on venous ulcer patients
without regard to infection risk and treating patients with SIR for the full study rather than resuming
normal dressings once infection risk had passed.
SIR benefits become more apparent on wounds that are at measureable risk of infection or clearly are
not healing. This effect may be similar to that of Manuka honey, which is associated with more
prominent healing benefits in more serious non-healing ulcers.6 Should SIR studies be stratifying
analyses or subject assignment by risk severity, wound depth, duration or necrotic tissue, or ASEPSIS
score? Better minds than mine with more clinical experience will identify more appropriate variables for
infection risk covariate analyses to gain a clearer understanding of SIR as a treatment option potentially
affecting subjects at high risk of infection.
SIR are not licensed to heal. They function as microbial barriers helping to manage infection risk.
Should systematic reviews analyze early, more dynamic granulation and/or epithelization outcomes to
identify capacity of SIR to shepherd wounds past episodes of high infection risk? The study reviewed
above by Beele et al used sound operational definitions of infection risk as criteria for enrollment, and
clear outcome measures to track wound progress in terms of both infection risk and dynamic healing
responses. Once infection risk is lowered, SIR are no longer indicated.
The clinical implication of these findings is that we should pay careful attention to using SIR on the right
patients at the right time and measure their efficacy in terms of clinically valid results linked to reducing
infection, not merely to healing.
References
1. Storm-Versloot MN, Vos CG, Ubbink DT, Vermeulen H. Topical silver for preventing wound
infection. Cochrane Database Syst Rev. 2010;3:CD006478.
2. Vermeulen H, van Hattem JM, Storm-Versloot MN, Ubbink DT. Topical silver for treating infected
wounds.
Author(s):
Cochrane Database Syst Rev.2008(1);CD005486.
3. Toy LW, Macera L. Evidence-based review of silver dressing use on chronic wounds. J Am Acad
Nurse Pract. 2011;23(4):183–192.
4. Jorgensen B, Price P, Andersen KF, et al. The silver-releasing foam dressing, Contreet Foam,
promotes faster healing of critically colonized venous leg ulcers: a randomized, controlled trial. Int
Wound J. 2005;2(1):64–73.
5. Jude E, Apelqvist I, Spraul M, Martini J. Prospective randomized controlled study of non-ischaemic

diabetic foot ulcers dressed with Hydrofiber® containing ionic silver or calcium alginate
dressings. Diabet Med. 2007;24: 280–288.
6. Bolton LL. Leg ulcers and honey: a review of recent controlled trials. In: Cooper R, Molan P, White R,
eds. Honey: A Modern Wound Management Product. Shaftesbury, Dorset: Wounds UK Books;
2008:16–29.
7. Michaels JA, Campbell B, King B, Palfreyman SJ, Shackley P, Stevenson M. Randomized controlled
trial and cost-effectiveness analysis of silverdonating antimicrobial dressings for venous leg ulcers
(VULCAN trial). Br J Surg. 2009; 96:1147–1156.
8. Leaper D. Should one size fit all? An overview and critique of the VULCAN study on silver
dressings. Int Wound J. 2011;8(1):1–4.
Topical Antimicrobial Therapy for Treating Chronic

Wounds
1. Benjamin A. Lipsky1,2 and
2. Christopher Hoey1
+ Author Affiliations
1. 1
Veterans Affairs Puget Sound Health Care System and University of Washington, School
of Medicine, Seattle
2. 2University of Washington, School of Medicine, Seattle
1. Reprints or correspondence: Dr Benjamin A. Lipsky, VA Puget Sound Health Care System, S-111-PCC 1660 S
Columbian Way, Seattle, WA 98108 (balipsky@u.washington.edu).
Next Section
Abstract
Various agents have been applied topically to treat infected wounds for millennia, but their proper
role remains unclear. Topical therapy affords many potential advantages but also has
disadvantages. Opinions differ on which clinical signs define wound infection and on whether
quantitative microbiological studies are useful. Clinically infected wounds usually require
systemic antibiotic therapy, whereas clinically uninfected wounds that are healing as expected do
not require antimicrobials. There is controversy over how to treat poorly healing wounds with
“secondary” signs suggesting infection; these may benefit from topical antimicrobial agents. Some
evidence supports using topical agents for malodorous or burn wounds. Meta-analyses and
systematic reviews suggest there are few proven indications for topical antimicrobials. Use of a
newer, relatively nontoxic antiseptic (eg, cadexomer iodine or silver dressings) is preferable to use
of topical antibiotics, especially agents that are available for systemic use. We provide clinically
relevant information on currently available topical antimicrobial agents.
Perhaps the most deceptively simple of all therapeutic procedures is the treatment of cutaneous
infection with topical medication. Despite the unique accessibility of the skin to scientific
investigation, it has for too long been the playground of crude empiricism. —Professor Sydney
Selwyn, 1981[1]
Chronic skin wounds affect ∼3% of persons aged >60 years [2] and are usually related to
neuropathy (eg, diabetic foot or pressure ulcers), vasculopathy (venous stasis or arterial
insufficiency ulcers), or trauma. Patients with chronic wounds are frequently treated with either
systemic or topical antimicrobial therapy. Two studies in Europe found that >60% of these
patients had received some form of antibiotic therapy in the previous 6–12 months, typically for a
prolonged duration [3, 4]. In the nearly 3 decades since Professor Selwyn's summary of the state
of the art of topical therapy [1], we still know surprisingly little about the role of antimicrobials
applied to infected wounds. This paper briefly reviews the concepts germane to considering
topical antimicrobial therapy, describes the agents currently available, and offers suggestions
about when they may be useful. We will not deal with topical antimicrobials for treating
nonbacterial infections, acne, noncutaneous (eg, optical, otic, or mucosal) conditions, or for hand
hygiene or prophylaxis to prevent wound infection. We must begin by defining when a wound is
infected.
Previous SectionNext Section
How Should We Define Wound Infection?
Virtually all open wounds are colonized with microorganisms, but this usually has no clinical
consequences, because they show no evidence of infection and heal as expected [5]. Some wounds
are clearly infected; they have purulent secretions or some of the cardinal manifestations of
inflammation (erythema, warmth, pain or tenderness, or induration) that have classically defined
the host response to tissue damage caused by pathogenic and invasive microorganisms [6]. The
likelihood that a wound will become infected is related directly to the inoculum size and virulence
of the colonizing organisms and inversely related to local and systemic host resistance [7]. But
some wounds occur in patients with neuropathy (which may obscure or cause pain), ischemia
(which may reduce erythema, warmth, or induration), or venous insufficiency (which may mask
warmth or cause induration). Because these conditions limit the expression of inflammation, some
define infection by “secondary” signs of local infection, (eg, nonpurulent exudate, discolored or
friable [easily bleeding] granulation tissue, breakdown or “pocketing” at the wound base, or an
abnormally foul odor) [6, 8]. A Delphi approach by an international group of 54 wound care
experts produced consensus on criteria they deemed common to infection in all chronic wounds:
“cellulitis,” malodor, pain, delayed healing, deterioration or breakdown, and increased exudate
[9]. Some of these criteria have purportedly been validated by studies of various wounds in several
settings, but the findings are limited by the fact that they compare the clinical criteria to
inadequately validated microbiological definitions of infection [10]. Furthermore, the “additional”
(if not the “traditional”) evidence of infection likely varies for different types of chronic wounds
[6].
Others approach the diagnostic problem by defining infection microbiologically, suggesting that
apparently uninfected but nonhealing wounds may demonstrate either “critical colonization” with
certain virulent species or a heavy bacterial “bioburden,” usually defined as ⩾105colony forming
units per gram of tissue [11]. This concept remains controversial, and recent studies suggest it is
less the density of organisms than the presence of particular species (eg, Pseudomonas
aeruginosa, Peptostreptococcus species, or Morganella morganii ) [11], the diversity of bacteria,
or the patient's response to colonization that lead to a nonhealing but uninflamed wound [2].
Cultures of wound specimens usually grow aerobic gram-positive cocci, which are often mixed
with gram-negative bacilli and sometimes anaerobes, but molecular diagnostic studies have shown
a greater microbial complexity than had previously been recognized (Table 1). Furthermore,
recent studies have demonstrated that, in many chronic wounds, bacteria persist in adhesive,
polymeric matrix biofilm communities, in which they induce chronic inflammation that delays
healing and that they are more resistant to antimicrobial therapy [15]. These findings have led to
suggestions that, in wounds that are apparently properly treated but that fail to heal, the clinician
should consider topical antimicrobials.
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Table 1
Bacterial Species Isolated from Various Types of Wounds in 3 Studies Using Optimal Culture and
Molecular Techniques
Why Consider Topical Therapy?
With many systemic antibiotics available, why consider topical antimicrobial therapy for an
infected wound? Even if the in fection remains confined to superficial tissues, it may cause
delayed healing, exudation, or malodor. Although some wound infections will heal with no
antimicrobial therapy, many—particularly in immunocompromised or anatomically compromised
hosts—will progress to involve deeper tissues and potentially cause systemic infection. These
processes are largely mediated by toxins and metabolic wastes produced by microorganisms but
also by the host response to infection [16]. For millennia, healers have applied various compounds
to infected wounds, some of which (eg, silver and honey) we still use today. Compared with
systemic antibiotic therapy, topical application has many potential advantages, as well as some
disadvantages, as outlined in Table 2[17, 18]. To overcome known deficiencies, clinicians and
industry have defined the ideal potential topical agent, as summarized in Table 3[19]. Topical
antimicrobials have traditionally been formulated as ointments, which are more occlusive, often
contain petrolatum, and are best for dry lesions; and creams, which are less occlusive, wash off
with water, are less messy, and are best for moist lesions. One gram of cream covers ∼100 cm2of
skin, whereas ointments cover a 5%-10% larger area. Newer technologies incorporate
antimicrobials into dressings, such as alginates, foams, and sponges, allowing controlled release at
the wound surface. One major problem with topical therapies is that there are no specific tests of
these agents that have been standardized and approved by any official oversight agency for
evaluating their efficacy.
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Table 2
Potential Advantages and Disadvantages of Using Topical Antimicrobial Therapy for Infected
Chronic Wounds
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Table 3
Properties of an Ideal Topical Antimicrobial for Treating Chronic Wounds

What Types of Topical Antimicrobials Are Available?
Disinfectants are agents with activity against virtually all disease-causing microorganisms,
including spores; they are used primarily for sterilizing inanimate surfaces and may be toxic to
tissues. Most topical antimicrobials can be divided into 1 of 2 major groups:
Antiseptics. Antiseptics are disinfectants that can be used on intact skin and some open wounds to
kill or inhibit microorganisms. They often have multiple microbial targets, a broad antimicrobial
spectrum, and residual anti-infective activity but are often toxic to host tissues (eg, fibroblasts,
keratinocytes, and possibly leukocytes).
Antibiotics. Antibiotics are chemicals produced either naturally (by a microorganism) or
synthetically that in dilute solution inhibit or kill other microorganisms. They usually act on one
specific cell target, have a narrower spectrum of activity, are relatively nontoxic, and are more
susceptible to losing their effectiveness to bacterial resistance.
Antiseptics. These compounds have antibacterial and desloughing actions and are generally safe
when applied to intact skin. Most agents can cause some toxicity to host cells in vitro, such as
prolonging the acute inflammatory response or delaying the production of collagen, but these
effects are not usually noted in vivo [16, 20]. Some older agents (eg, sodium hypochlorite and
hexacholorphene) are now infrequently used for infected wounds. Commonly used antiseptics
(see Table 4) include hydrogen peroxide, which has limited bactericidal and debriding activity;
chlorhexidine, which has long-acting activity against a wide range of both gram-negative and
gram-positive bacteria; and iodophors, which release free iodides but may be cytotoxic. Iodines
have been used for >150 years without bacteria developing resistance [21]. Newer formulations,
such as cadexomer iodine, offer sustained delivery of bactericidal concentrations to moist wounds
without apparent tissue damage. Silver compounds (metallic, nanocrystalline, and ionic) have a
broad bactericidal spectrum and have enjoyed a recent resurgence as topical antiseptics in various
types of wound dressings. Silver ions kill bacteria by several mechanisms, including dam aging
their cell walls, membranes, respiratory enzymes, and ribonucleoproteins [22, 23]. Because they
are rapidly inactivated in the wound environment, they require a sustained delivery formulation.
Silver has proven efficacy against several common wound pathogens, including methicillin-
resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), and extended-
spectrum β-lactamase producers. Resistance is rare but has been reported, mostly with gram-
negative species [19]. Adverse effects are infrequent, and silver may be active against biofilm.
Silver compounds in various wound products differ in the manner and speed with which they
release the bactericidal silver ions [22]. Although silver dressings have been the subject of many
anecdotal reports and case series, they have been used in few well-designed clinical trials.
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Table 4
Topical Antiseptic Products Available for Treating Chronic Wounds

Another newly popular topical remedy for wound infections is honey. Its beneficial actions are
related to the osmotic effect produced by the high sugar content but also to the presence of an
enzyme that produces hydrogen peroxide, as well as to nonperoxide antibacterials [24]. Honey has
an inhibitory effect on >50 species of bacteria, including clinical strains of MRSA and VRE, and
there is no reported microbial resistance. It has demonstrated clinical effectiveness for various
types of wound infections; dramatically decreases skin colonization with many bacteria, including
MRSA [25]; hastens wound healing; and rarely causes adverse reactions. Medical grade honey
(eg, Manuka) is approved in many countries and there are several sterile, irradiated, antibacterial
(Unique Manuka Factor-rated) brands available [24, 26, 27]. Clinicians should avoid using
nonmedical honeys that may contain viable spores (including clostridia) and have unpredictable
antibacterial activity.
Because chronic wounds are so common, it is not surprising that new agents are frequently
introduced. Super-oxidized water is a recently approved antiseptic, one brand of which (Microcyn;
Oculus) is available without prescription. This pH-neutral sterilant with reactive species of
chlorine and oxygen in a stable formulation is rapidly bactericidal, has broad-spectrum coverage,
does not appear to facilitate bacterial resistance or damage host tissues, and may be active in the
presence of biofilm [28]. It can be applied directly to wounds or be combined with dressings or
other wound products, and several small, nonrandomized studies suggest it is effective in treating
infected diabetic foot ulcers [29–31]. Antimicrobial peptides are another novel approach to topical
therapy. These small (<100-amino acid), cationic, amphipathic compounds are stored in granules
of polymorphonuclear leukocytes and epithelial cells in most eukaryotes [32, 33]. They are rapidly
bactericidal against a broad spectrum of organisms and synergistic with—although unrelated to—
other antimicrobials. Acquired resistance rarely develops. Pexiganan, a peptide awaiting US Food
and Drug Administration approval that is applied in a 1% cream, is bactericidal for most aerobic
and anaerobic, gram-positive and gram-negative pathogens [34–36], and there are no reports of
cross-resistance to other antibiotics. In 2 randomized, controlled trials that enrolled patients with a
mildly infected diabetic foot ulcer, topical pexiganan proved overall to be similarly effective
clinically and microbiologically to oral ofloxacin, with fewer adverse events [37].
Antibiotics. Clinically infected wounds should usually be treated with systemic antibiotic therapy.
The first topical antibiotics were derived from agents developed for systemic use (ie, sulfonamides
in the mid-1930s), followed in the next decade by topical penicillins, bacitracin, gramicidin,
aminoglycosides (including neomycin), polymixin, tetracyclines, and cholor-am-phen-i-col.
Agents introduced later include fusidic acid, clindamycin, metronidazole, mupirocin and
retapamulin. Only a few topical antibiotics are commonly used in the US (Table 5). Neomycin is
active against most aerobic gram-negative rods (excluding mostPseudomonas species) and
staphylococci (but not most other gram-positive cocci); resistance develops relatively frequently,
as does contact dermatitis. Polymixin is active against some gram-negative rods
(including Pseudomonas species) but not gram-positive cocci; systemic absorption is uncommon,
and dermatitis is rare. Bacitracin is active against most gram-positive organisms, and resistance
and toxicity are uncommon. These 3 antibiotics are combined in a nonprescription ointment
commonly used on wounds by patients and some providers. It is best to avoid using topical
antibiotics that are available for systemic therapy when treating wound infections, because they
can provoke delayed hypersensitivity reactions, favor superinfections, and select for resistant
pathogens. One exception is metronidazole, which can reduce the fetid odor of (presumably)
anaerobically colonized wounds [38].
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Table 5
Topical Antibiotic Products Available for Treating Chronic Wounds

Antibiotics used only in topical formulations may be appropriate for treating some infected
wounds. Mupirocin is active against aerobic gram-positive cocci (except enterococci) and has
minimal toxicity, and cross-resistance is uncommon. Although it is sometimes used off-label for
treating or decolonizing (especially if MRSA is present) chronic wounds [39], published studies
supporting this indication are lacking, and the incidence of resistance is increasing. Retapamulin,
which was approved in 2007, is a 1% semisynthetic pleuromutilin compound with in vitro activity
against most gram-positive bacteria (and anaerobes). Although it is indicated for impetigo in both
the United States and the European Union, only the latter has also approved it for treating wounds
(small lacerations, abrasions, or sutured wounds) infected with Streptococcus pyogenes or S.
aureus (excluding MRSA strains). Although retapamulin has good in vitro activity against MRSA,
it has not yet been proven to be clinically effective [40]. It has a low potential for organisms to
develop resistance and has not shown cross-resistance to other antimicrobial classes. Retapamulin
has been shown to be similar in efficacy to topical fusidic acid and to oral cephalexin for treating
impetigo or infected traumatic lesions [40–42], but there are no data on use of this agent for
chronic wounds.
What Is the Evidence for Using Topical Antimicrobials for Treating Chronic Wounds?
Available data make it difficult to assess the efficacy of topical antimicrobials for chronic wounds.
Most studies are suboptimal and have varying designs that are not easily comparable. To start,
specifications for in vitro testing of these agents are not standardized among countries [43].
Animal models also yield inconsistent evidence, depending on the experimental species, type of
wound induced, and microorganisms used; many are probably irrelevant to chronic wounds in
patients, who often have underlying medical conditions. Although the anecdotal reports and case
series involving humans provide some information, clinical trials are the test of efficacy.
Unfortunately, many of the published trials do not define the types of patients and wounds
included, select inappropriate control groups, or have inadequate sample sizes. Because wound
infection is ill-defined, comparison of study outcomes is difficult. So what do the published
clinical trials tell us about the efficacy of these agents?
A 2001 systematic review of controlled trials of antimicrobial agents for chronic wounds (diabetic
foot ulcers, pressure ulcers, chronic leg ulcers, etc.) found 30 studies (25 randomized trials) with a
total of 1436 patients that met the inclusion criteria [44]. The authors concluded that few systemic
agents improved outcomes, but several topical substances hastened healing, including silver-
containing compounds for venous ulcers and oxyquinoline ointment for stage 1–2 pressure ulcers.
A 2008 Cochrane systematic review of antibiotics and antiseptics for venous leg ulcers concluded
that some evidence supports using topical cadexomer iodine, but further research is required to
determine the effectiveness of povidone iodine, peroxide-based preparations, ethacridine lactate,
and mupirocin for healing venous leg ulcerations [45]. Similarly, a 2008 systematic review of the
effectiveness of various interventions for enhancing the healing of chronic diabetic foot ulcers
found a single study that demonstrated no benefit of cadexomer-iodine in cavitary wounds and one
suggesting that zinc oxide tape improved necrotic wounds more than a hydrocolloid [46]. A 2006
Cochrane review of silver-based wound dressings and topical agents for treating diabetic foot
ulcers found no controlled trials that met basic design requirements and that reported outcomes on
healing rates or infection resolution [47]. Likewise, a 2007 Cochrane review of silver-containing
dressings or topical agents for treating infected or contaminated chronic wounds concluded there
was insufficient evidence, on the basis of 3 randomized, controlled trials (each with a short
follow-up duration), to recommend this treatment [48]. Use of honey for treating wounds was the
subject of a 2008 Cochrane systematic review. On the basis of data from 19 trials (totaling 2554
patients) that met the inclusion criteria, the authors concluded that, compared with some
conventional dressings, honey may reduce the healing time for mild-to-moderate superficial and
partial thickness burns but did not significantly hasten leg ulcer healing; for other uses, there was
insufficient evidence to guide clinical practice [49].
What Can We Conclude about Topical Antimicrobial Therapy for Chronic Wounds?
Although some take strong positions on either side of the debate, most clinicians are confused
about whether and when to use topical antimicrobials for chronic wounds and which topical
antimicrobial to use. Wound care should always begin with ensuring adequate debridement,
removal of any foreign bodies, pressure off-loading, and proper dressings, then assessing for (and
treating when needed) any arterial or venous insufficiency, or metabolic derangements. Then,
classify the wound to determine the approach to antimicrobial therapy (Table 6). Clinically
infected wounds usually require systemic antibiotic therapy, with the exceptions mentioned
previously. Topical antimicrobial therapy, although not currently advisable for most clinically
uninfected chronic wounds, does have a role in specific circumstances. Evidence upholds its use
for burn wounds in which blood vessels to the skin are often destroyed, both to prevent sepsis and
help treat infection [50]. Some data support use of topical agents for eradicating wound bacteria
prior to skin grafting or for reducing odor associated with nonhealing, necrotic wounds. Clinicians
could consider adding topical antimicrobials, which achieve high local levels, to systemic
antibiotics in a patient with an infected ischemic wound who cannot undergo revascularization.
One can reasonably argue for trying a short course of a topical antiseptic (preferably one of the
newer, safer preparations, such as iodine or silver dressings) for an otherwise properly managed
wound that is failing to heal and has some secondary findings suggesting subclinical infection.
Another potential application might be to help in the removal of biofilms, which have been
implicated in persistent infections. Some in vitro tests of iodides, silver, and hydrogen peroxide
(and, thus, peroxide-generating honey) compounds show inhibition or disruption of biofilm [43].
Topical treatments may also prove helpful with the increasing problem of multidrug-resistant
organisms that are untreatable with most systemic agents. A recent study of 47 multidrug-resistant
organisms from burn wounds found that most were susceptible to 11 commonly used topical
antibiotics and antiseptics, although the rates of resistance were higher than to non-multidrug-
resistant organisms [50].
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Table 6
Recommended Approach to Using Topical Antimicrobials for Treating Chronic Wounds in

Various Clinical States
The main arguments against using topical antiseptics are the lack of adequate proof of efficacy
and residual concerns about their potential toxicity to healing wounds. A compound's toxicity risk
depends on the particular formulation, concentration of active ingredient, and duration of
exposure. Newer formulations and methods of applying topical antiseptics appear to reduce the
risk. Antiseptics should not be used in solutions, because they are more likely to cause cell
damage and have no demonstrated benefit over saline irrigation [5]. Newer topical creams,
ointments, gels, and dressings appear to provide adequate, sustained, and apparently nontoxic
levels of antiseptics. Unfortunately, there is little information on systemic absorption of the agents,
and evidence of clinical efficacy is meager. Thus, clinicians should currently use these products
very selectively and only for a short duration. Investigators and the industry are seeking other
ways to deal with chronic wound infections, including various innovative nonantimicrobial
approaches. In light of the size and importance of the problem of chronic wound infection, we
expect crude empiricism to continue to give way to creative entrepreneurship.
Acknowledgments
We thank Mia Hannula (medical librarian at Veterans Affairs Puget Sound Healthcare System) for
assisting with our systematic review of the literature on this topic, as well as the following
authorities who responded to our request to provide their written opinions on the topics covered in
this article: Keith Cutting (High Wycombe, England) Michael Edmonds (London, England), John
Embil (Winnipeg, Canada), Lawrence Eron (Honolulu, HI), Keith Harding (Cardiff, Wales), Jan
Hirschmann (Seattle, WA), Alberto Piaggesi (Pisa, Italy), L. Neal Sharpe (Louisville, KY), and
Luc Téot (Montpelier, France).
Potential conflicts of interest. B.A.L. has received recent research funding from Ortho-McNeil
Janssen, Merck, and Cubist; has served as a consultant for Pfizer, Wyeth-Ayerst Laboratories, and
Coloplast; and has served as a speaker for Pfizer. C.H.: no conflicts.
 Received May 24, 2009.
 Revision received June 26, 2009.
 Accepted October 20, 2009.
 © 2009 by the Infectious Diseases Society of America
Previous Section
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Review of the clinical RCT
evidence and cost-
effectiveness data of a
sustained-release silver foam
dressing in the healing of
critically colonised wounds
Presented at a symposium at the 2nd World Union of the Wound Healing
Societies, Paris, France, 2004
Author(s) Contents
R Gary Sibbald  Introduction
MD, MEd
Professor of Medicine and Public Health Sciences,
 Evidenced-based medicine and
wound care
University of Toronto, Canada
 Identifying infection
Email: gary.sibbald@utoronto.ca  Sustained-release silver foam
dressing
Sylvie Meaume  Clinical research - management
MD, PhD of bacteria and exudate
Head of Department of Geriatrics,  Health-economic analysis
Groupe Hospitalier Charles Foix, Ivry Sur Seine, France  Discussion
 Conclusion
Robert S Kirsner  References
MD, PhD
Associate Professor
Department of Dermatology and Cutaneous Surgery, Department
of Epidemiology and Public Health, University of Miami School of
Medicine, USA
Karl-Christian M�nter
MD
General Practitioner, Phlebology, Hamburg, Germany
Published: December 2005

Last updated: January 2006
Revision: 1.1
Keywords: Sustained-release silver foam dressing; evidence-based medicine;

critically colonised wounds; cost-effectiveness.
Key Points
1. There is a need for evidence to support the use of dressings containing

silver in the management of critically colonised wounds.
2. In wound care, a new model needs to bridge the gap between the ideal
and reality. This could be used to critically evaluate specific treatment
procedures where there is only limited clinical and investigational evidence
to support their use.
3. The use of an evidence-based medicine model can provide a framework
for future analysis of the efficacy (clinical studies), efficiency (everyday
practice) and effectiveness (relative cost) of new technologies in wound
care.
Abstract
This paper presents clinical evidence on a sustained-release silver foam dressing

in chronic wounds with regard to efficacy, efficiency and effectiveness of
evidence-based medicine. The results are derived from a randomised, controlled,
clinical trial (efficacy), a real-life, randomised comparative study from everyday
practice (efficiency), and a health-economic evaluation (effectiveness). The
results indicate that this sustained-release silver foam dressing provides
particular benefit for the treatment of critically colonised wounds. It is suggested
that the use of the evidence-based medicine model may be a benchmark for a
new level of clinical evidence in wound management.
Introduction
Over the past few years there has been increased use of dressings containing
silver, although there is only limited clinical and investigational evidence
supporting specific treatment procedures. It has been suggested that silver
dressings may be of particular benefit when used for the treatment of critically
colonised wounds. This paper discusses the evidence base for a sustained-release
silver foam dressing (Contreet Foam), focusing on three areas:
 Clinical research - efficacy (clinical studies)

 Outcomes research - efficiency (everyday practice)
 Health-economic analyses - effectiveness (cost-effectiveness).
The results from a randomised, controlled clinical study including 109 patients are
reviewed, as well as a comparative study from everyday practice involving more
than 600 patients, and a health-economic analysis.
Evidenced-based medicine and wound care
The highest level of evidence is required in order to practise evidence-based

medicine[1]. This is particularly challenging in the field of wound care. Sackett
(2000) defined evidence-based wound management as the integration of best
research evidence with clinical expertise and patient values[2]. In practice,
healthcare practitioners must review the best research evidence, and interpret
and compare the research with the current methods of practice[1].
An assessment of the whole patient, the underlying cause, and any patient-
centered concerns must be considered before examining the wound itself[3][4].
The concept of wound bed preparation includes debridement, control of bacteria
and exudate management[3]. Wound bed preparation provides a framework to
facilitate accurate diagnosis and treatment of patients with chronic wounds
utilising holistic care and a team approach. The algorithm in Figure 1 identifies
the components that should be considered in order to achieve the maximum
benefit when using advanced wound care products [3][4]. In evidence-based
medicine, efficacy, effectiveness and efficiency are three key concepts (see Box
1) [5]. These principles of evidence-based medicine are incorporated into this
algorithm, emphasising that these issues should be integral to modern wound
management.
Figure 1 - Wound bed preparation and evidence-based medicine.
[Adapted from Sibbald et al, 2000 [3].]
Box 1: Evidence-based care
Efficacy is measured through controlled clinical research trials involving carefully

selected patients and outcomes.
Efficiency investigates the ability of a new treatment to be translated into

everyday practice.
Effectiveness relates to the cost of the new treatment. Cost-effectiveness

includes cost of the treatment, health professional time and clinical outcomes. If
the product cost is higher, there must be savings with faster healing rates, a
decreased frequency of dressing changes, or a significant improvement in the
patient's quality of life.
Identifying infection
All chronic wounds contain bacteria and the presence of bacteria obtained from a
surface swab does not mean a wound is infected. The diagnosis of infection
should be made clinically based on signs and symptoms of the local wound bed,
the deeper structures and the surrounding skin. While clinicians have traditionally
correlated bacteria number with outcomes, other factors are at play, including
virulence and host resistance, as outlined in the equation [6]:
Host resistance is the ability of the host to resist bacterial invasion and the
establishment of an increased bacterial burden or infection. There are systemic
and local factors that can decrease host resistance. An increase in organism
number and virulence of organisms causes the superficial wound bed to produce
friable bright red granulation tissue, with an increased amount of slough on the
surface, as well as increased discharge and odour. Decreased host resistance
allows further bacterial proliferation and invasion of the organisms into deeper
tissue.
Bacterial presence in a chronic wound can be described as a continuum starting

with contamination or colonisation (bacterial balance) and ending with critical
colonisation or infection (bacterial imbalance) as outlined in Figure 2.
Figure 2 - Progression of bacterial balance to bacterial damage in a chronic

wound. Clinical pictures courtesy Dr R Gary Sibbald.
Some signs of critical colonisation in a wound are listed in Tables 1 and 2 .

Chronic wounds change with time in a dynamic process and must be continuously
re-evaluated and re-classified.
Table 1: Clinical signs of critically colonised wounds
 A delay in the healing process

 Increased serous or purulent exudate
 Foul odour (usually due to anaerobes and Gram-negative organisms)
 Small areas of yellow to brown slough may be present on the surface of the wound
 Exuberant granulation builds up on the surface. Bacterial interference results in a poor quality of collagen matrix that will not
support re-epithelialisation and healing. The granulation is often a bright red colour and may bleed easily especially on
dressing removal (increased blood vessels and poor quality collagen support).
The signs described in Table 1 are localised in the superficial wound bed and are
potentially treatable with topical agents, including ionised silver [7][8][9][10].
When host resistance is compromised, bacterial damage can extend beyond the
local wound bed. More extensive bacterial damage results in a deeper and
surrounding skin compartment infection that usually requires systemic
antimicrobial treatment. The presence of surrounding skin pain, warmth and
swelling with erythema and possible increase in wound size or new areas of
satellite breakdown should alert the clinician to the possibility of a co-existing
soft-tissue infection (cellulitis).
If the deep portion of the ulcer probes to bone, osteomyelitis is a possibility,

especially if the patient is diabetic with neurotrophic foot ulceration [11]. With
infection of the surrounding or deeper structures the wound often increases in
size and there may be satellite areas of breakdown Table 2. At this stage, a
bacterial swab can be used as a guide to treatment. It is necessary to make
treatment decisions before the swab results are available. In general, wounds of
less than one month's duration require treatment for Gram-positive organisms;
however, if the wound has been present for more than one month, coverage for
Gram-positive, Gram-negative and anaerobic organisms will be needed [12].
Table 2: Signs of critical colonisation and infection [13]
Superficial  Non-healing
 Exuberant granulation
Topical therapy, for example silver dressings
 Bright red colour
 Increased exudate
 New slough within bed
 Odour
Deep and surrounding skin  Pain

 Probes to bone
Systemic therapy
 Surrounding erythema or oedema > 2cm
 Surrounding warmth, tenderness
 Increasing size
 Satellite areas of breakdown
Sustained-release silver foam dressing
The sustained-release silver foam dressing (Contreet Foam) comprises a soft

hydrophilic polyurethane foam containing silver as an integral part of the dressing
matrix [14]. The foam component provides a partial fluid lock to help prevent
maceration of the surrounding wound margin by the absorbed wound fluid. Silver
ions are present in a form that is readily hydro-activated in the presence of fluid
or wound exudate [14]. The sustained-release silver foam dressing is active
against a variety of micro-organisms including Staphylococcus aureus, methicillin-
resistant Staphylococcus aureus (MRSA), Pseudomonas aeruginosa and
vancomycin-resistant enterococci (VRE). The sustained release of silver from this
dressing has been demonstrated for up to seven days [15] [16].
The potential advantage of a foam and silver dressing combination is that surface
bacterial counts can be reduced while removing excess exudate from the wound
surface.
Clinical research - management of bacteria and exudate
Efficacy
A clinical study reported elsewhere[17][18][19] was conducted comparing a

sustained-release silver foam dressing with a foam dressing without silver
(Allevyn Hydrocellular) in patients with venous or mixed venous/arterial leg ulcers
and signs of stalled or delayed healing caused by suspected critical
colonisation [9][20][21] . The primary aim of this study was to evaluate the
relative reduction of ulcer size. The secondary aim was to assess wound-bed
preparation. Bacterial balance was measured indirectly through a decrease in
wound odour and the presence of healthy granulation tissue. Exudate
management was measured through exudate leakage from the dressing and the
absorption capacity of the dressing. The degree of maceration was also
evaluated.
The study had a block randomisation, multi-centre comparative design. It was

conducted in 15 centres predominantly in Europe, with two North American sites
in Canada and the USA. There were 109 evaluable patients with chronic non-
healing venous and mixed arterial and venous ulcers entered into the study. Fifty-
two patients were randomised to the sustained-release silver foam dressing group
and 57 patients to the foam dressing without silver group. The study was
conducted for four weeks or until complete wound closure. The inclusion
criteria comprised: an ankle/brachial index of 0.65 or higher, moderately to
highly exudating wounds, delayed healing and treatment with compression
therapy for four weeks prior to the study. Ulcers had to show signs of increased
bacterial load characterised by one or more of the following: increased exudate,
increased pain, discoloration of the granulation tissue and/or foul
odour. Exclusion criteria included: the presence of clinical infection (deep or
surrounding skin symptoms and signs) that required treatment with systemic
antibiotics, and treatment with antibiotics or antiseptics for one week prior to
inclusion.
All patients were treated with appropriate compression therapy. After four weeks,
the median relative reduction in ulcer area was 45% with the sustained-release
silver foam dressing and 25% with the foam dressing without silver as shown
in Figure 3 (p=0.0344, Wilcoxon two-sample test). There was a statistically
significant difference in the reduction of wound odour in favour of the sustained-
release silver foam dressing after one and four weeks (p=0.0013 and 0.0301,
respectively, using the Wilcoxon two-sample test), while both groups
demonstrated an increase in the presence of healthy granulation tissue.
At one week fluid leakage was noted in 27% of the sustained-release silver foam
dressing changes compared with 44% of the foam alone group (p=0.06, Wilcoxon
two-sample test). At the end of the study, there were significantly fewer dressing
changes associated with exudate leakage in the sustained-release silver foam
dressing group (19%) compared with the foam dressing without silver group
(49%; p=0.002, Wilcoxon two-sample test). The sustained-release silver foam
dressing had a significantly better absorption capacity compared with the foam
dressing as evaluated on a five-point scale by study personnel at the end of
treatment (p=0.04, Wilcoxon two-sample test).
Figure 3 - Median relative ulcer area expressed as a percentage of baseline over

four weeks of treatment
Adapted from J�rgensen B et al. Int Wound J 2005[19].
Outcomes research - the CONTOP study
Efficiency
The sustained-release silver foam dressing has also been evaluated in an

effectiveness study in real-life settings. The Contreet Outcome Program
(CONTOP) study, was conducted at more than 80 wound care centres in ten
countries and has more than 600 patients enrolled. An interim analysis is
reported on the first 352 patients with complete data available [22]. The
endpoints in this study are the reduction in wound area, wound progress, exudate
management, and patient-related outcomes. This study included a number of
venous leg ulcers in addition to other aetiologies as shown in Table 3. Patients
were randomised to receive either the sustained-release silver foam dressing or
treatment in accordance with local best practice, that is the usual treatment
provided by the clinic (see Table 4). The study duration was four weeks.
Table 3: Frequency of ulcer types included in the CONTOP study
Ulcer types Frequency of ulcers
Sustained-release silver foam dressing Local best practice
Venous leg ulcers 43% 48%
Mixed venous/arterial leg ulcers 24% 20%
Pressure ulcers 7% 7%
Diabetic foot ulcers 9% 5%
Other 17% 20%
Table 4: Frequency of selected dressing types in the local best practice control group in the CONTOP study
Dressing type Frequency
Foam/alginates 45%
Hydrocolloid dressings/films 15%
Gauze 4%
Antibiotic/antimicrobial 30%
 Silver dressings 14% (48%)

 Other
16% (52%)
Other 6%
The silver foam dressing decreased wound size by 50%, with the comparators
reducing wound size by 30% (p=0.006, Wilcoxon two-sample test). There was
also a statistically significant increase in the presence of normal granulation tissue
in 68% of the sustained-release silver foam-treated patients and 50% of the local
best practice group (p=0.002, Wilcoxon two-sample test). Exudate management
was evaluated by dressing wear time: the sustained-release silver foam dressing
group averaged 3.8 days, which was significantly longer than the local best
practice group average of 2.3 days (p=0.0001, Wilcoxon two-sample test). The
study also revealed that the sustained-release silver foam dressing showed
statistically significant advantages in odour reduction and pain relief as well as
the clinical ease of use of the dressing [22].
Health-economic analysis
Effectiveness
Traditionally the consideration of treatment costs in wound care has been limited
to dressing costs alone. However, to properly evaluate the financial impact of a
treatment strategy on a healthcare system, outcomes also need to be considered.
In an analysis of the cost-effectiveness of using the sustained-release silver foam
dressing the outcomes considered were average dressing wear-time, the healing
time of the ulcers, cost of medical and nursing time for assessment and
treatment, and the cost and frequency of complicating infections. A
spreadsheet Figure 4 and a Markov model Figure 5[23][24] were designed to
perform these health-economic analyses. The two health-economic models were
based on methods and procedures from published cost-effectiveness
models [23][24]. The analyses were performed with a societal perspective in a
UK and German context. The model design and data were validated by a UK and
German panel consisting of wound care experts. Following advice from the expert
panels, the models were then adjusted and re-analysed and relevant sensitivity
analyses were performed to assess the robustness of the models.
The analyses compared four different wound-care dressings used in the treatment
of delayed healing venous leg ulcers. A four-week limit was applied in the main
models for UK and Germany Figure 4. The Markov model assured that this four-
week model had a realistic link to cost-effectiveness of complete wound
closure. Figure 5 [25].
Figure 4 - Spreadsheet model. Reproduced with permission of the International

Wound Journal.
[See footnote below ***]
Figure 5 - Markov model. Reproduced with permission of the International

Wound Journal.
[*** Figure 4 and Figure 5 have been reproduced with permission from: Scanlon E, Karlsmark T, Leaper DJ,
Carter K, Poulsen PB, Hart-Hansen K. Cost-effective faster wound healing with a sustained silver-releasing
foam dressing in delayed healing leg ulcers - a health-economic analysis. Int Wound J 2005; 2(2): 150-60. �
Blackwell Publishing. ]
The costs of the dressings - and secondary dressings where needed - were
determined and the weekly cost per dressing change was calculated using the
data from Table 5 and Table 6 [25] [26]. The costs associated with materials
including dressings, dressing change frequency, clinician time, and infection were
compiled from relevant local sources [25] [26]. Costs specifically related to
dressings are outlined in Table 6.
Table 5: Overview of clinical studies of antimicrobial wound dressings included in the analysis
Reduction in wound area Dressing changes References

per week (%) per week
Sustained-release silver foam dressing (Contreet (Karlsmark et al 2003; Sibbald et al

12.6 2.2
Foam) 2004) [14] [17] *
Sodium carboxymethylcellulose dressing

6.0 1.9 (Vanscheidt et al 2003) [27])
containing silver (Aquacel Ag)
Activated charcoal cloth with silver dressing

11.2 3.6 (Tebbe and Orfanos 1996) [28]
(Actisorb Silver 220)
Cadexomer iodine paste (Iodoflex) 9.0 2.7 (Hansson et al 1998) [29]
* data pooled from two different studies.
Table 6: Cost data for the four dressing alternatives in UK and Germany
Cost per dressing (euro)
United Kingdom Germany
Primary Secondary Total Primary Secondary Total
Sustained-release silver foam

10.43 Not necessary* 10.43 11.5 Not necessary* 11.5
dressing (Contreet Foam)
Sodium carboxymethyl- 14.2 (self-adhesive,

2.91 (non-adhesive, absorbent:
cellulose dressing containing 5.93 8.84 7.26 carboxymethoyl-cellulose island 21.46
CombiDERM-N)
silver (Aquacel Ag) dressing:Versiva)
Activated charcoal cloth with 4.32 (non-adhesive, 10.33 (non-adhesive,

silver dressing (Actisorb Silver 3.53 hydropolymer foam dressing: 7.85 5.46 hydropolymer foam dressing: 15.79
220) Tielle Plus Borderless) Tielle Plus Bordeless)
0.48 (knitted viscose, silicone

Cadexomer iodine paste
14.04 impregnated non-adherent 14.52 N/A N/A N/A
(Iodoflex)**
dressing: N-A Dressing)
* Contreet Foam does not need a secondary dressing. ** Iodoflex is not part of
the German models, as it is not available in Germany. The weekly cost per
dressing change was calculated as: Weekly dressing change cost = (Primary and
secondary dressing cost + Nursing time + Travel cost + Gloves + Wound
cleansing + Compression bandages) x Dressing changes per week x The cost of
risk of infection. The choice of secondary dressings was based on manufacturers'
instructions for use and the expert panels' advice. The size of the secondary
dressing was selected so it could fully cover the primary dressing. For the
sensitivity analysis, cheaper alternatives were selected, again based on the
expert panels' advice.
The results from the weekly cost per dressing change were used to calculate the
cost per percentage reduction in wound area as shown in Table 7[25][26].
Table 7: Frequency of ulcer types included in the CONTOP study
Cost per percentage relative reduction in wound area (euro)
United Kingdom Germany
Sustained-release silver foam dressing (Contreet Foam) 14.18 4.18
Sodium carboxymethyl-cellulose dressing containing silver (Aquacel Ag) 26.37 11.10
Activated charcoal cloth with silver dressing (Actisorb Silver 220) 24.81 8.90
Cadexomer iodine paste (Iodoflex) 25.43 NA
The differences in costs between UK and German results are primarily due to
different cost structures for nursing salaries in the two countries. [25][26].
Sensitivity analyses were performed to assess the robustness of the results. Both
the cost and efficacy data were altered up and down by 20%. These calculations
also included replacing the secondary dressings with less costly alternative
dressings where appropriate. The link between cost of relative reduction in wound
area and the cost per healed wound was ensured through the use of the Markov
model. The results from this Markov model confirmed the results from the four-
week model [25]. The sensitivity analyses showed that the models were robust
and that the sustained-release silver foam dressing was the most cost-effective
choice in regard to cost per relative reduction in wound area as well as cost per
healed wound [25].
Discussion
The importance of the bacterial load, the appearance of the superficial wound bed
including wound exudate, the host resistance, and the most appropriate course of
treatment for patients with critically colonised and infected wounds are subject to
debate and disagreement. The importance of evidence-based studies to support
optimal decision making for wound treatment cannot, therefore, be overstated.
This review article summarises the use of a sustained-release silver foam

dressing in the treatment of non-healing chronic wounds. Roma-Moore stated
that 'only controlled clinical evaluations ideally support final decisions about the
best treatments to use in achieving wound care outcomes'[30]. The evidence-
based medicine approach combined with the principles of wound bed preparation
led to the design of the first RCT of a moist wound healing silver dressing for
chronic wound care.
In this RCT, a sustained-release silver foam dressing significantly decreased

odour and exudate faster than the non-active foam dressing. The results showed
a 45% reduction in ulcer size from baseline for the sustained-release silver foam
dressing compared with 25% for the foam dressing without silver. In a recent
study by Vanscheidt et al evaluating a sodium carboxymethylcellulose dressing
containing silver (Aquacel Ag) the mean ulcer area was reduced by 23.9% over
the same period of time (four weeks) [27]. According to Flanagan (2003) a
percentage area reduction of less than 20-40% over the initial two to four weeks
of treatment is a reliable indicator that the wound is not responding well to the
treatment[31].
Randomised, controlled trials are often criticised because they do not represent
the full spectrum of patients in real-life settings. The CONTOP study was designed
to address the issues of everyday practice and has produced comparable results
to the randomised, controlled trial of the benefits of the sustained-release silver
foam dressing compared with local best practice. The results showed a 50%
reduction in ulcer size for the sustained-release silver foam dressing compared
with 30% for local best practice. In addition, the dressings were changed less
frequently in patients treated with the sustained-release silver foam dressing.
New products will not become part of everyday practice if they add additional
costs to the healthcare system. By calculating the total healthcare costs based on
evidence and expert opinion as developed in the models outlined in this paper,
the sustained-release silver foam dressing was demonstrated to provide cost-
effective treatment of wounds both in terms of cost per percentage relative
reduction in wound area and cost per healed wound. This is a preliminary
estimate of real clinical costing of the components that are included in cost-
effectiveness analyses. This concept needs to be prospectively tested in practice
and, depending on the clinical expertise, the healthcare system obstacles and the
cost of the product, these figures can change and need to be critically evaluated
for each healthcare delivery model.
Conclusion
The results of this analysis indicate that the sustained-release silver foam
dressing (Contreet Foam) is of particular benefit for the treatment of critically
colonised wounds. The use of an evidence-based medicine model provides a
framework for future analysis of the efficacy, efficiency and effectiveness of new
technologies in wound care. This model adds rigour and sets a benchmark for a
new level of clinical evidence. This is of particular importance in areas of wound
management where there is only limited clinical and investigational evidence to
support specific treatment procedures.
This article is supported by an educational grant from Coloplast. The views

expressed in this article are those of the authors and do not necessarily reflect
those of Coloplast.
The studies included in this review were supported by financial grants from
Coloplast A/S, Humlebaek, Denmark.
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J Clin Nurs. 2009 Mar;18(5):716-28. doi: 10.1111/j.1365-2702.2008.02534.x.

The effectiveness of silver-releasing dressings in the

Laura Bolton, PhD, FAPWCA

Pressure and Venous Ulcers

Non-healing Chronic Wounds

Cochrane Database Syst Rev.2008(1);CD005486.

5. Jude E, Apelqvist I, Spraul M, Martini J. Prospective randomized controlled study of non-ischaemic

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Topical Antiseptic Products Available for Treating Chronic Wounds

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Articles citing this article

Published: December 2005

Keywords: Sustained-release silver foam dressing; evidence-based medicine;

1. There is a need for evidence to support the use of dressings containing

This paper presents clinical evidence on a sustained-release silver foam dressing

 Clinical research - efficacy (clinical studies)

Evidenced-based medicine and wound care

The highest level of evidence is required in order to practise evidence-based

Figure 1 - Wound bed preparation and evidence-based medicine.

[Adapted from Sibbald et al, 2000 [3].]

Box 1: Evidence-based care

Efficacy is measured through controlled clinical research trials involving carefully

Efficiency investigates the ability of a new treatment to be translated into

Effectiveness relates to the cost of the new treatment. Cost-effectiveness

Bacterial presence in a chronic wound can be described as a continuum starting

Figure 2 - Progression of bacterial balance to bacterial damage in a chronic

Some signs of critical colonisation in a wound are listed in Tables 1 and 2 .

Table 1: Clinical signs of critically colonised wounds

 A delay in the healing process

If the deep portion of the ulcer probes to bone, osteomyelitis is a possibility,

Table 2: Signs of critical colonisation and infection [13]

Deep and surrounding skin  Pain

Sustained-release silver foam dressing

The sustained-release silver foam dressing (Contreet Foam) comprises a soft

Clinical research - management of bacteria and exudate

A clinical study reported elsewhere[17][18][19] was conducted comparing a

The study had a block randomisation, multi-centre comparative design. It was

Figure 3 - Median relative ulcer area expressed as a percentage of baseline over