Mepilex Ag: an antimicrobial, absorbent foam dressing with Safetac

Mepilex® Ag: an antimicrobial, absorbent
foam dressing with Safetac® technology
Simon Barrett
Abstract
This article examines the role of a unique dressing—Mepilex®
Ag—that incorporates the rapid and sustained antimicrobial action
of ionic silver with the benefits of Safetac® soft silicone adhesive
technology. The combined attributes of each component of this
dressing allow both the control of pain and infection to be achieved
simultaneously. This dual approach to the management of wounds is
of significance since the evidence suggests that wound infection and
the release of pro-inflammatory modulators result in both local pain
and delayed healing. In this respect the control and treatment of pain
is as important as the treatment of infection itself. A review of the
clinical evidence relating to Safetac technology clearly demonstrates
that it can be used to prevent dressing-related trauma, minimize
pain at dressing change, and control exudate when used on a wide
range of wound types and skin injuries. In combination with silver,
this technology has been shown in in-vitro studies to have an almost
instant and sustainable antimicrobial effect on a broad range of
pathogens associated with delayed healing. Finally, in small clinical
and case studies, Mepilex Ag has been shown to control wound
bioburden and improve healing rates.
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ilver-containing dressings are used for the management
of infection in acute and chronic wounds to reduce
bioburden, as an adjunct to systemic management of
wound infection and, occasionally, for prophylaxis
when patients are compromised and therefore at high risk of
wound infection or bioburden (Parsons et al, 2005; Collier,
2009). While a number of systematic reviews have concluded
that the quantity and quality of evidence is insufficient to
determine the true clinical benefit and cost-effectiveness of
silver-containing dressings (Chambers et al, 2007; Vermeulen
et al, 2007; Lo et al, 2008), the findings of the most recently
undertaken of these (Lo et al, 2008) strengthen the case for
their use. The main point to emerge from this systematic
review is that silver-releasing dressings show positive effects
on infected chronic wounds in five relevant dimensions: tissue
management, infection and inflammation control, moisture
balance, epithelial (edge) advancement, and cost-effectiveness
(Lo et al, 2008).
Simon Barrett is Tissue Viability Nurse Specialist, NHS East Riding
of Yorkshire Primary Care Trust, Yorkshire
Accepted for publication: October 2009
In a subsequent meta-analysis undertaken by the same
research group (Lo et al, 2009), it was revealed that silver
dressings significantly improved wound healing (P<0.001),
reduced odour (P<0.001) and pain-related symptoms
(P<0.001), decreased wound exudates (P<0.001) and had
a prolonged wear time (P=0.028), when compared with
alternative wound management strategies. The analyzed
studies also indicate an improvement in quality of life
(P=0.013) associated with the use of silver dressings in
wound management, with no associated severe adverse
events (Lo et al, 2009).
The proven antimicrobial activity of ionic silver includes
its broad-spectrum activity (Bowler et al, 2004; Jones et al,
2004) against Gram-positive and Gram-negative microorganisms and also its antibacterial effects on antibioticresistant bacteria, such as meticillin-resistant Staphylococcus
aureus (MRSA) and vancomycin-resistant enterococci (VRE)
(Lansdown, 2002; Thomas and McCubbin, 2003; Parsons et
al, 2005; Vermeulen et al, 2007). Its other positive attributes
include minimal toxicity at low concentrations (Demling and
DeSanti, 2001; Lansdown, 2007).
Mepilex® Ag (Mölnlycke Health Care, Gothenburg,
Sweden), created by combining Safetac® soft silicone
technology and silver-impregnated foam, is an advanced
wound dressing that has instant and sustained, broad-spectrum
antimicrobial activity, good absorption characteristics, and
is associated with atraumatic removal and minimal pain at
dressing change (Meuleneire, 2008). This is of significance to
the nurse practitioner since the recent evidence suggests that
overtly infected wounds are associated with increased levels of
pain (Lansdown, 2007) and that painful and infected wounds
are slower to heal (Ovington, 2003). In addition, trauma and
skin stripping associated with traditional dressing adhesives
may further delay healing due to increased pain levels at
dressing changes which, in turn, can lead to increasing stress
levels for the patient.
A variety of studies have shown that raised stress levels can
delay wound healing (Kiecolt-Glaser et al, 1995; Marucha
et al, 1998; Glaser et al, 1999; Garg et al, 2001; Soon and
Acton, 2006), and even the anticipation of dressing changes
can adversely effect the patient with a chronic wound which
requires multiple dressing changes over a sustained period of
time. In a large-scale study, the European Wound Management
Association (EWMA, 2002) concluded that the most important
strategy for avoiding wound damage, and hence anticipatory
distress, was the use of non-traumatic dressings.They identified
hydrofibres, hydrogels, alginates, and soft silicones to be least
likely to cause trauma, but sadly the survey indicated that
This article is reprinted from the British Journal of Nursing, 2009 (Tissue Viability Supplement), Vol 18, No 20
Figure 1. Composition of Mepilex® Ag.
Foam pad
• Contains silver sulphate/activated carbon
• Absorbs exudate
• Works under compression
• Conforms to body contours
Film backing
• Moisture vapour-permeable
• Waterproof
Safetac soft silicone wound contact layer
• Atraumatic to wound and surrounding skin
on removal
• Does not adhere to moist wound bed
• Adheres gently to peri-wound skin,
allowing easy application of secondary fixation
• Minimizes risk of maceration
moist wound environment. It consists of: a Safetac soft silicone
wound contact layer; an absorbent, polyurethane foam pad
containing a silver compound (silver sulphate) and activated
carbon; and a vapour-permeable waterproof film (Figure 1).
In the presence of fluid (e.g. wound exudate), silver ions
are released from Mepilex Ag to inactivate a wide range
of wound-related pathogens, as demonstrated in in-vitro
studies (Davoudi et al, 2007; Taherinejad and Hamberg,
2008), described in more detail later in this article.
The dressing is intended for use on exuding wounds at risk
of infection such as leg ulcers, diabetic foot ulcers, pressure
ulcers, surgical wounds and burns. In light of the evidence
to date, the clinical indications for the use of Mepilex Ag
may be identified as to manage exudate production; reduce
bacterial burden; protect the surrounding skin; minimize
the risk of complications such as infection – in those
patients assessed as at enhanced risk; prevent trauma and
pain associated with dressing changes and to optimize the
local healing environment as well as the patient’s healing
potential.
Safetac
Table 1. Results of growth assays of Pseudomonas
aeruginosa incubated with eluates of different
dressings (with and without human serum)
Dressing aliquot Growth – without
human serum
Growth – with human serum
Mepilex Ag No growth up to 48 hours No growth up to 48 hours
Contreet Growth after 18 hours No growth up to 48 hours
Acticoat MC Growth after 18 hours Growth after 24 hours
Cellosorb Ag Growth after 10 hours Growth after 10 hours
Silvercel Ag Growth after 10 hours Growth after 10 hours
Acticoat 7 Growth after 10 hours No growth up to 48 hours
Tegaderm Ag Growth after 6 hours Growth after 10 hours
From: Davoudi et al (2007)
financial and reimbursement issues were the most important
factors influencing clinicians’ choice of dressings rather than
the likelihood of reducing pain.
In patients with chronic wounds, pain is a commonly
reported experience (Charles, 1995; 2002; Reddy et al, 2003;
Ribu and Wahl, 2004) and has been described as a devastating
aspect of living with a chronic wound. (Hofman et al, 1997).
This has implications with regard to reduced quality of
life (Charles, 1995) and the need to treat pain at dressing
changes with topical opioids or tricyclic antidepressants which
complicates any treatment programme and also introduces
cost implications. Such observations reinforce the need to use
atraumatic dressings where possible when treating chronic
wounds. Additionally, the ideal dressing should also maintain
a moist environment, absorb exudate, and remain in situ over
a number of days.
Mepilex Ag
Mepilex Ag is an antimicrobial, absorbent, soft silicone foam
dressing that is designed to absorb exudate and maintain a
Safetac is a patented soft silicone adhesive technology
which has proven efficacy in terms of preventing trauma
to the wound and surrounding skin, and in minimizing
pain during use and at dressing changes. Dressings utilizing
Safetac do not adhere to moist wounds, but adhere gently to
the peri-wound skin, thereby avoiding further trauma and
minimizing dressing-related pain. They also manage wound
exudate effectively. The seal that forms between intact
skin and a dressing with Safetac inhibits the movement of
exudate from the wound onto the surrounding skin, thereby
reducing the risk of maceration (White, 2005).
Positive outcomes have been recorded with respect to
abolition of adherence (Dahlstrøm, 1995), reduced levels of
pain (White, 2008; Morris et al, 2009), and reduced stress
levels at dressing changes (O’Donovan et al, 1999).The range
of wounds for which evidence for the positive attributes of
Safetac technology has been reported include leg ulcers
(Zillmer et al, 2006; White, 2008; Barrows, 2009; Woo et al,
2009), diabetic foot ulcers (Young, 2002; Misgavige, 2005;
White, 2008; Tong, 2009), pressure ulcers (Meaume et al,
2003; White, 2008; Barrows, 2009), burn wounds (Bugmann
et al, 1998), including partial-thickness burns (Gotschall et al,
1998; Fowler, 2006), newly grafted burn wounds (Platt et al,
1996), post-tumour excision wounds requiring skin grafting
(Dahlstrøm, 1995), traumatic wounds (O’Donovan et al,
1999; Terrill and Varughese, 2000), skin tears (Meuleneire,
2002), and a variety of paediatric wounds (Bugmann et al,
1998; Gotschall et al, 1998; Morris et al, 2009). The practical
advantages of Safetac technology include the fact that
dressings incorporating it may be lifted and adjusted without
losing their adherent properties, and that they can be used
under compression bandaging, if required.
A number of studies (involving volunteers and patients)
have demonstrated reduced pain levels at dressing change
when using dressings that incorporate Safetac (Platt et al,
1996; Dykes and Heggie, 2003; Meaume et al, 2003; White,
2008; Woo et al, 2009). For example, in a randomized
This article is reprinted from the British Journal of Nursing, 2009 (Tissue Viability Supplement), Vol 18, No 20
product focus
Figure 2. Antimicrobial effect of Mepilex Ag against a broad range of microorganisms, including
antibiotic-resistant strains and yeast (adapted from Taherinejad and Hamberg, 2008).
6
Log10 reduction
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crossover study comparing an all-in-one island dressing
utilizing Safetac (Mepilex® Border, Mölnlycke Health Care)
with an adhesive (acrylic) polyurethane foam dressing in
terms of pain severity scores in patients with chronic ulcers
before dressing change and at dressing removal, Woo et al
(2009) demonstrated significantly lower scores associated
with the use of the dressings with Safetac (P<0.05). The
dressings with Safetac were also preferred by both patients
and investigators in terms of overall performance and
conformability to wounds and surrounding skin (P<0.05).
Fluid handling capability was rated significantly higher for
dressings with Safetac (P<0.001), as was ease of removal
(P<0.001). The superior fluid handling capacity of the
dressings with Safetac minimized peri-wound maceration
and skin irritation from corrosive exudate which may
explain the lower levels of pain reported before dressing
removal and at dressing removal.
Other studies have demonstrated benefits of Safetac in
relation to reduced levels of pain, exudate control, reduced
maceration, and improved healing in a broad range of
wound types including oncology wounds, skin disorders
such as epidermolysis bullosa, peristomal skin complications,
radiotherapy-induced skin damage, scar management, and
as an adjunct to negative pressure wound therapy (Weiner,
2004; Dunbar et al, 2005; Majan, 2006; Mekrut-Barrows,
2006; Rice and Fellows, 2006; Davies
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Figure 3. Antimicrobial effect of Mepilex Ag against five common wound pathogens
(adapted from Taherinejad and Hamberg, 2008).
30 minutes
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C. albicans E. faecalis VRE P. aeruginosa
S. aureus
MRSA
Figure 4. Antimicrobial effect of Mepilex Ag against five common wound pathogens (adapted from
Taherinejad and Hamberg, 2008).
Day
1 2 3 4 5 6 7
5
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This article is reprinted from the British Journal of Nursing, 2009 (Tissue Viability Supplement), Vol 18, No 20
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Log10 reduction
The silver component of Mepilex Ag, which in normal
circumstances is inert, becomes ionized in the presence
of wound exudate and in this state demonstrates a broadspectrum antimicrobial effect. Davoudi et al (2007) have
shown in both in-vitro and in-vivo tests that Mepilex Ag
has an antibacterial effect against a broad range of pathogens
associated with delayed healing. In this respect, the dressing
was found to be active against 19 different bacterial
isolates, including Staphylococcus aureus, derived from chronic
wounds. In vitro assessments of the antimicrobial action of
Mepilex Ag against Pseudomonas aeruginosa also demonstrated
this antibacterial effect to be greater or comparable to that
of other silver-containing dressings (Table 1). Application of
the dressing was also shown to block protein degradation
and attenuate release of bacterial enzymes, which is clearly
of benefit given that infected and chronic wounds are
generally suspended in the inflammatory phase of the
healing continuum due to the persistence of proteases
released by pathogens in the wound bed. The distinction
between non-infected acute wounds and chronic or hardto-heal wounds is that acute wounds move through the
three phases of healing in a timely manner following the
cessation of protease release which allows transition to the
proliferative stage of healing followed by a remodelling
phase (Eming et al, 2007).
Davoudi et al (2007) also reported on a case study of a
patient with a venous leg ulcer that was associated with an
improved healing response after commencing treatment
with Mepilex Ag. Analysis of the used dressings revealed
reduced bacterial contamination within them after 4 weeks
of treatment.
Log10 reduction
Laboratory studies
Box 1. Case study 1: male aged 73 years
Past medical history
• Rheumatoid arthritis
• Skin grafts for ulcers – donor sites (thigh)
• 30-year history of left ankle ulcer (caused by trauma)
• Bilateral fixed ankle joints
• Bilateral orthopaedic surgery to ankles; knee replacement; hip replacements
• Reduced mobility due to surgery and arthritis
• Ability to tolerate only light compression (approximately 23 mmHg) at the ankle
• Ankle brachial pressure index values: right leg 1.14, left leg 1.05
• Calf muscle wastage due to gait
• Previously under the care of rheumatology, dermatology, plastics and vascular teams with multiple admissions.
16 February 2009
The patient attended the clinic to enquire if there were any new products that could be used to treat his longstanding leg ulcer.
Diagnosed as being critically colonized, the wound measured 10 cm x 6 cm and was associated with moderate levels of exudate of
low viscosity. The patient was advised of the difficulties in healing his wound and the need to focus treatment on managing and
controlling the symptoms of localized infection. It was decided to commence treatment with an antimicrobial dressing.
Leg ulcer prior to treatment with Mepilex Ag
Mepilex Ag applied to leg ulcer Leg ulcer after four weeks of treatment with Mepilex Ag 2 March 2009
The wound had deteriorated significantly and was associated with high
volumes of exudate, a strong malodour, and increased pain/soreness.
Visual Analogue Scale score increased from 2 (baseline) to 6 on a scale
of 0 (no pain) to 10 (worst pain ever). The patient was very concerned
about the malodour, pain and maceration. In order to regain control of
the wound and to manage the symptoms, treatment with Mepilex Ag was
commenced, with dressing changes undertaken every 3 days.
Leg ulcer after 2 weeks of treatment with Mepilex Ag
30 March 2009
Four weeks after starting treatment with Mepilex Ag, the malodour was
considerably less. Exudate levels, which had reduced but still relatively
high, were effectively managed with Mepilex Ag. Pain severity had
also returned to the baseline score (2). The wound bed had improved to
the point where the next phase of planned treatment (amelogenin
(Xelma®, Mölnlycke Health Care) in conjunction with Mepilex Ag,
if required) could be considered.
Outcomes
• Resolution of localized infection
• Reduced pain at dressing change
• Effective management of exudate
• Good wound bed preparation for next phase of treatment
• Dressing demonstrated good conformability
• Patient found dressing comfortable to wear
• Patient happy with treatment progress and pleased with management of symptoms of localized infection.
This article is reprinted from the British Journal of Nursing, 2009 (Tissue Viability Supplement), Vol 18, No 20
product focus
Box 2. Case study 2: male aged 81 years
Past medical history
• Hip replacements (x3)
• Osteoarthritis
• Ulceration on left leg (intermittent since 2001)
• Episodes of cellulitis
• Toe amputation (second digit on right foot)
• Ankle brachial pressure index values: 1.22/1.5; mixed aetiology biphasic signals; mixed aetiology symptoms
(e.g. claudication, venous staining)
• Positive for meticillin-resistant Staphylococcus aureus (MRSA) (previously and recently)
15 December 2008
The patient presented with an ulcer on his left inner ankle (area: 5 cm x 5 cm; duration: 6 months). The ulcer had an inflamed edge
with maceration and areas of dry flaky skin in evidence.
Leg ulcer prior to treatment with Mepilex
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26 January 2009
A treatment regime including the use of Mepilex Ag and elevation was
initiated.
Leg ulcer after 3 days of treatment with
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Mepilex Ag�
29 January 2009
Three days later, the wound was swabbed. Dressing removal was
atraumatic. Exudate levels were being well-managed with Mepilex Ag and
the condition of the wound bed was improving.
Leg ulcer after 7 days of treatment with
�����������������
Mepilex Ag�� 2 February 2009
One week after commencing treatment with Mepilex Ag, the wound
exhibited 100% healthy granulation tissue, no signs of localized infection
and medium levels of exudate of low viscosity.
Leg ulcer after 16 days of treatment with
����������������
Mepilex Ag�
11 February 2009
Sixteen days after commencing treatment with Mepilex Ag, the wound
had reduced in size by 30%.
This article is reprinted from the British Journal of Nursing, 2009 (Tissue Viability Supplement), Vol 18, No 20
Box 2. Case study 2: male aged 81 years (continued)
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Leg ulcer after 9 weeks of treatment with Mepilex Ag 9 March 2009
Approximately 9 weeks after commencing treatment with Mepilex Ag,
the wound had almost healed (area: 0.5cm x 0.5cm) and exhibited 100%
re-epithelialization with low levels of exudate of low viscosity.
Leg ulcer after 11 weeks of treatment with Mepilex Ag 25 March 2009
Dry eschar was removed. The wound had healed completely (the healed
skin had a darkened appearance; MRSA negative). The leg remained
ulcer-free, thus enabling the patient to be considered for further hip
replacement surgery (16 April 2009).
Outcomes
• Wound bioburden controlled (resolution of MRSA infection)
• Complete wound healing
• Effective management of exudate
• Dressing associated with atraumatic removal and very comfortable for patient
• No adverse incidents
• Patient happy with treatment
• Patient able to undergo orthopaedic surgery that had been delayed due to open wound and MRSA infection
• Anticipated improvement in patient’s quality of life following surgery to improve his mobility (more able to support his
wife who is in a poor state of health) and resolve joint pain.
Davoudi et al’s findings are both supported and expanded
upon by a recently completed laboratory study conducted
by Taherinejad and Hamberg (2008). This study demonstrated
the broad-spectrum antimicrobial activity of Mepilex Ag,
including its effects against antibiotic-resistant strains and
yeast (Figure 2). It also demonstrated the dressing to have
a practically instant and sustained antimicrobial activity
(Figures 3 and 4) (Taherinejad and Hamberg, 2008). The
figures show that bacteria were inactivated within 30 minutes,
with the level of inactivation increasing when assessed at 180
minutes.The silver-containing dressing also showed a sustained
antimicrobial effect over 7 days as illustrated in Figure 4.
The implications of this are important in that such rapidity
of action and sustained effect reduces the possibility of the
development of resistant strains of bacteria. These in vitro
studies also showed Mepilex Ag to be active against existent
resistant strains such as MRSA. The persistent antimicrobial
activity associated with this product also suggests that longer
wear times are acceptable with this type of dressing, which
may lead to reduced costs associated with fewer demands on
nursing time, reduced outlay on dressings, and a reduced need
for treatment with antibiotics. Furthermore, the avoidance of
frequent dressing changes, leads to less disturbance of the
wound bed, so providing the best opportunity for the wound
to heal (Phillips, 2000). Additionally, the reduced trauma
associated with dressing changes, due to the use of Safetac
technology as described earlier, may play a role in improving
the quality of life in patients with chronic wounds as well as
controlling exudate levels and peri-wound skin maceration.
Of the many in vitro techniques that are used to assess the
antimicrobial activity of silver, logarithmic reduction tests,
as utilized in the studies described above (Davoudi et al,
2007; Taherinejad and Hamberg, 2008), are reported to be a
powerful method for assessing silver antimicrobial efficacy in
complex media and can be used to generally predict clinical
effectiveness (Nadworny and Burrell, 2008).
Clinical evaluations
As well as the in vitro evidence supporting the instant and
sustained action of Mepilex Ag across a range of microorganisms (Taherinejad and Hamberg, 2008) and the studies
assessing the levels of trauma and pain when using dressings
with Safetac, a variety of studies have demonstrated the
clinical efficacy of the dressing with respect to decreasing
levels of pain (Durante, 2008; Kheng, 2008; Meuleneire, 2008;
Nisbet, 2008; Timmins, 2008; Barrows, 2009), decreasing
bioburden (Davoudi et al, 2007; Durante, 2008; Meites et
al, 2008; Meuleneire, 2008; Barrows, 2009), increasing rates
of healing (Davoudi et al, 2007; Kheng, 2008; Meuleneire,
2008; Nisbet, 2008; Durante, 2008; Schumann et al, 2007;
Tong, 2009), and reducing levels of exudate (Davoudi et
al, 2007; Timmins, 2008; Barrows, 2009) in a wide variety
of acute and chronic wounds. Mepilex Ag has also been
shown to be of use in the dressing of pin sites following
This article is reprinted from the British Journal of Nursing, 2009 (Tissue Viability Supplement), Vol 18, No 20
product focus
surgical procedures for the management of Charcot midfoot
deformities (Bevilacqua, 2008).
In an attempt to demonstrate the clinical benefits of Mepilex
Ag, a series of case studies are presented (Boxes 1 and 2). They
clearly highlight the efficacy of Mepilex Ag in treating wounds
at risk of infection and provide further evidence of the ability
of the dressing to provide an environment conducive to
healing, control exudate, prevent trauma to the wound and
peri-wound skin, and minimize pain at dressing change.
It is important to note that the results of the clinical
evaluations of Mepilex Ag undertaken to date are noncomparative and based on relatively small patient population.
Although this indicates a requirement for larger and
comparative clinical evaluations to be undertaken, the
findings clearly provide an insight into the effectiveness and
safety of Mepilex Ag in the ‘real-life’ clinical setting.
Conclusion
Wound infection results in both local pain and delayed
healing. Pain-related stress is thought to reduce the immune
response to infection, hence implying that the treatment
of pain is as important as the treatment of infection itself.
The development of Mepilex Ag has provided clinicians
with a dressing that is unique in that the Safetac component
addresses dressing-related trauma and pain whilst the silver
component controls bioburden.
The incorporation of Safetac adhesive technology in the
design of Mepilex Ag imparts a number of benefits on the
dressing.The sealing effect of Safetac inhibits the movement of
exudate from the wound onto the surrounding area, thereby
helping to prevent maceration of the peri-wound region.
The fact that the dressing does not adhere to the wound bed
makes it atraumatic on removal, so avoiding painful dressing
changes and disturbances in the wound-healing process that
result in delayed healing. Reduced pain levels due to the
atraumatic nature of the dressing may also reduce or negate
the need for the use of analgesics or antidepressants at the
time of dressing changes.
The silver component of Mepilex Ag demonstrates an
antimicrobial effect on a broad range of wound-related
pathogens, including antibiotic-resistant strains. The rapidity
with which the antibacterial effect is achieved and the fact
that its effect is sustained should help to minimize the risk of
microbial resistance, and may enable prolonged dressing wear
time, thus potentially saving nursing resources.
The results of the case studies and observational studies
undertaken to date strongly indicate that, when used as
directed, Mepilex Ag is an effective and safe dressing for use
BJN
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Key Points
nMepilex Ag combines the antimicrobial action of ionic silver with the
benefits of Safetac technology.
nRapid silver release inactivates pathogens within 30 minutes of contact
and maintains a sustained release action for up to 7 days.
nSafetac technology protects the peri-wound skin, reduces the risk of
maceration, prevents trauma to the wound, and minimizes pain at
dressing changes.
nMepilex Ag provides optimal odour control.
nMepilex Ag may be used under compression bandaging.
nMepilex Ag is easy to apply, can be lifted and adjusted without losing its
adherent properties, and can be cut to size.
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