Askina® Calgitrol® Paste

Technical Brochure

Wound Management

AskinaCalgitrol_Scientific_Rationale_120503.indd 1 03.05.12 17:30

  Areas of Unmet Needs in Acute and 3  Safety and Tolerability 9
and Chronic Wound Management  Systemic Safety 9
 Development and Mechanism of Action of 4  Local Tolerability 9
Askina Calgitrol Paste
® ®
 Appropriate Wound Types and 10
 Rationale 4 Application Instructions
 Mechanism of Action 5  In Summary 10
 Targets and Mechanisms of Bacterial Cell Kill 7  References 11
by Ionic Silver
 Antimicrobial Activity 8

AskinaCalgitrol_Scientific_Rationale_120503.indd 2 03.05.12 17:30

 Areas of Unmet Needs in Acute and Chronic
Wound Management
Table 1. Calgitrol® Ag dressing range: One technology, three products
Askina® Calgitrol Ag Askina® Calgitrol THIN
Foam + silver alginate matrix Silver alginate matrix in thin form
Wounds are a major cause of morbidity in a number of patient
populations. They may be acute or chronic in nature, frequently
becoming susceptible to infection and requiring extensive levels
of daily care. Patients with peripheral vascular diseases (eg,
venous and arterial ulcers), diabetes (eg, diabetic foot ulcers),
and burns, as well as geriatric populations (eg, pressure ulcers)
are particularly susceptible to wound infections.
[Frykberg RG 2003; Gist S et al 2009]
The demographic changes occurring in many countries, with
increases in the aged population and prevalence of type 2 dia-
betes, are expected to lead to an increase in the number of such
patients at risk from wound infections.
[Frykberg RG 2003; Gist S et al 2009]
Evidence shows that, particularly in the hospital setting, wounds
may become infected with antibiotic resistant microorganisms
difficult to treat with systemic or topical antibiotics. For example,
a loss of antimicrobial activity against Gram-positive and Gram-
negative bacteria has been observed as a consequence of bac-
terial exposure to the sulphonamide component of silver sulfadi-
azine (SSD).
[Lowbury EJL et al, 1976]
AskinaCalgitrol_Scientific_Rationale_120503.indd 3
Askina® Calgitrol Paste
Amorphous silver alginate matrix
Treatment-resistant wound infections may therefore result in
serious complications, including sepsis and/or amputation.
[Bridges K et al 1977; Driver VR et al 2004; White RJ and Cooper R 2005]
The use of ionic silver−containing antimicrobial wound dressings
has become a well established therapeutic approach in response
to the challenge of antibiotic resistant wound infections. Accor-
dingly, a wide variety of fiber-, foam- and mesh-based dressings,
that topically deliver silver to the wound site are available. How-
ever, the rigid form of these dressings may impose limitations to
their effectiveness, particularly in difficult-to-treat wounds. In
these cases, the lack of intimate contact between the dressing
and the wound often prevents the silver ions from reaching all
potentially infected areas within the wound bed. These limita-
tions prompted the development of Askina® Calgitrol® Paste, a
new, innovative, and unique product that allows more intimate
contact between the wound and the antimicrobial silver ions
contained in the Calgitrol® Paste. The paste complements the ex-
isting range of Askina® Calgitrol® dressings that are more suited
to flat or superficial wounds (Table 1).
03.05.12 17:30
 Development and Mechanism of Action of Askin a®
Rationale
Table 2. Characteristics of Askina® Calgitrol® Paste
Characteristic Calgitrol® Paste
Formulation Paste
Silver type 100 % ionic silver
Silver content [Ag] 6.4 - 14.8 mg/g paste
12 mg/g
Average [Ag]
180 mg of Ag/15 g tube
Class Class 3 product
Askina® Calgitrol® Ag and THIN, which are standard flat dressing
forms, and Askina® Calgitrol® Paste consist of a complex silver
alginate matrix with recognized and proven clinical applicability
and effectiveness. The silver alginate matrix is composed of inter-
stitial layers of calcium and silver alginate molecules, inter-
spersed with bonded water (8 % −10 % of the matrix). Upon
exposure to the wound exudate, absorption of moisture by the
matrix leads to softening and swelling of the alginate structure,
which facilitates a controlled and steady state release of ionic
silver into the wound without losing the structural integrity of
the matrix itself. The Askina® Calgitrol® range of products do not
require the use of sterile water to prime antimicrobial activity as
they contain bonded water, and the silver ions are evenly distri-
buted in the matrix readily available for wound treatment (Table 2).
Silver dressings using Calgitrol® technology are ready for use
and do not require prior wetting to prime activity
The ionic silver−containing Askina® Calgitrol® Ag dressing has
demonstrated antimicrobial effectiveness in a randomized clinical
trial involving patients with infected chronic (pressure ulcers,
venous ulcers, diabetic foot ulcers) and acute wounds.
[Trial C et al 2010]
Further studies have demonstrated clinical benefits in the
management of patients with partial-thickness burns and other
chronic and acute wounds.
[Ricci E et al 2007; Opasanon S et al 2010; Aramwit P et al 2010]
AskinaCalgitrol_Scientific_Rationale_120503.indd 4
Calgitrol® Ag dressing
Standard dressing forms a surface gel
100 % ionic silver
96 - 222 mg/100 cm2
141 mg/ 100 cm2
Class 3 product
[B. Braun; Report HOSP 263, 2008]
The clinical value and success of the Askina® Calgitrol® Ag flat
dressings prompted the design and development of Askina®
Calgitrol® Paste. Calgitrol® Paste is, therefore, a highly conform-
able paste composed of the same ionic silver alginate matrix used
in the Askina Calgitrol® Ag flat dressings. The paste, however,
contains a greater water content (43 %) than the Calgitrol® Ag
dressings, conferring unique moisturizing features to Calgitrol®
Paste (Table 2).
In addition, the high conformability of Askina® Calgitrol® Paste al-
lows intimate contact between the active ionic silver alginate
matrix and the wound bed, which is particularly valuable in diffi-
cult-to-manage wounds such as those with tunnels and sinuses,
seen in patients with second-degree burns and diabetic foot ul-
cers. The synergy created by the intimate wound contact and the
sustained release of ionic silver enables rapid killing of wound-
infecting microorganisms by Askina® Calgitrol® Paste.
Askina® Calgitrol® Paste is highly conformable allowing inti-
mate contact between the ionic silver alginate matrix and
the wound bed
03.05.12 17:30
in a® Calgitrol® Paste
Mechanism of Action

Table 3. Properties of Askina® Calgitrol® Paste associated with clinical benefit

Characteristic Calgitrol® Paste Clinical benefit

Silver content
Linkage of silver ions
Controlled bioavailability of
silver ions
Release of silver ions
~180 mg of silver/15 g tube Ensures long-term antibacterial action
Silver ions are linked to the polysaccharide
The matrix acts as reservoir providing
molecules of the alginate, building a complex
steady release of ionic silver
matrix
A silver-sodium ion exchange process controls
No systemic toxicity (argyria)
release of silver ions from the matrix
Optimal concentration of ionic silver is main-
Controlled diffusion of ionic silver tained topically, with immediate start of the
antibacterial action

Askina® Calgitrol® Paste has a high ionic silver content and a
unique silver alginate matrix which absorbs wound exudates,
maintains molecular integrity, and acts as a reservoir providing a
controlled, rapid, and sustained release of ionic silver to the
wound over time (Table 3).
Askina Calgitrol Paste contains an average of ~12 mg ionic sil-
® ®
ver per gram of paste (corresponding to ~180 mg/15 g tube of
ionic silver) which ensures long-lasting antimicrobial activity.
Silver ions in the Askina® Calgitrol® Paste are bound to the poly-
saccharide molecules of the alginate matrix. The combination of
these moieties acts as a reservoir for the silver ions, which are
then steadily released into the wound environment, thus avoiding
silver ‘dumping’ and the complications associated with an exces-
sive, rapid deposition of ionic silver.
In moist wound environments, exudates are typically absorbed
into the matrix, leading to a swelling of the alginate and conse-
quent dissociation of the silver and calcium alginate bonds
(Figure 1).
Since the silver-alginate bonds are weaker than the calcium-algi-
nate bonds, they rupture first, leading to a preferential, controlled
release of silver ions from the matrix. Such release provides for
an extended, effective, and steady state delivery of ionic silver to
the wound site. Sodium ions from the exudate replace the silver
ions in the matrix, which maintains its molecular integrity over
time, thus providing a reservoir and continuous source of ionic
silver.

AskinaCalgitrol_Scientific_Rationale_120503.indd 5 03.05.12 17:30

 Figure 1. Release of ionic silver from the silver alginate matrix

2. Swelling of the silver alginate

matrix and bond dissociation
Ca Ca Ca Ca Ca
Ag Ag Ag Ag Ag Ag Ag Ag Ag Ag
Alg Alg Alg Alg Alg
Ca Ca Ca Ca Ca
Ca Ca Ca Ca Ca
Ag Ag Ag Ag
Ag+ Ag+ Ag+ Ag+
Ca Ca Ca Ca Ca
Ag Ag Ag Ag Ag Ag Ag Ag Ag Ag
Alg Alg Alg Alg Alg Ag+
Ca Ca Ca Ca Ca
Ca Ca Ca Ca Ca
Na +
Ag
+

Na + 1. Absorption of 3. Controlled and Ag+

exudate into sustained delivery

Na +
the matrix of ionic silver Ag+ A g+

Na +

Ag
Ag

+
+
Ag
+
Na + Na +
Ag
+

Na +
Na

Ag

+
Ag
+

+
Na
+
Na Na
Na
+
A g+

Na +
+
Na

Skin Wound bed Paste

Intimate contact

The flow of silver ions from the alginate matrix into the wound
Extended release from the alginate matrix ensures that
occurs by mass action law, with silver ions moving from high to
active ionic silver is delivered steadily over time and reaches
low concentration areas. The extended release from the alginate
antimicrobial concentrations in the wound
matrix ensures that active ionic silver is delivered steadily over
time, reaching immediate and effective antimicrobial concentra-
tions in the wound (Figure 1).

This controlled bioavailability of silver ions ensures high antimi-

crobial wound activity without the risk of over-delivery of silver
ions, the resultant wound discoloration, and potential for sys-
temic absorption and toxicity.

AskinaCalgitrol_Scientific_Rationale_120503.indd 6 03.05.12 17:31

 Targets and Mechanisms of Bacterial Cell
Kill by Ionic Silver

Figure 2. Sites of ionic silver antimicrobial activity in target bacteria

Cytoplasm
Ag+
Ag+

Bacterial cell wall Ag+ A g+

Loss of bacterial integrity Nucleoid

A g+
Ag+
Ag+
Bacterial DNA proteins
Capsule Inhibition of bacterial division
A g+

Cell wall Ag+

Cytoplasmic Ag+ Ag+

Membrane Ag+

Ag+
Ribosomes
Ag+

Pili Ag+
A g+

Figure adapted from Molecular

Bacterial proteins Expressions Web site. Michael
Impairment of bacterial metabolism Davidson and the Florida State
Energy stores depletion University Research Foundation.
http://micro.magnet.fsu.edu.
Accessed January 2012.

[Feng QL et al 2000; Lansdown AB 2010]

The in vitro and in vivo antimicrobial activity of ionic silver is
directed against multiple bacterial target sites, thus reducing
the probability of generating resistance after repeated use, as it
may be observed with the most frequently used antibiotics (eg,
sulfonamides).
[Bridges K et al 1977; Gupta A et al 1998; Driver VR 2004; Chopra I 2007]
Release of ionic silver in the vicinity of wound-infecting bacte-
ria induces, in the majority of cases, a bactericidal rather than
bacteriostatic effect against multiple bacterial strains including
Staphylococcus aureus, Escherichia coli, and Pseudomonas aeru-
ginosa.
[Feng QL et al 2000; Jung WK et al 2008]

Upon release from the matrix, active ionic silver targets three
critical bacterial structures (Figure 2).
[Feng QL et al 2000; Lansdown AB 2010]
 The bacterial wall, with loss of bacterial integrity and
pathogenicity
 The bacterial protein structure, synthesis, and enzymatic
activity, with impairment of the intracellular metabolic
pathways and energy stores
 The bacterial DNA, with inhibition of DNA replication
and cell division
Ionic silver is directed against multiple bacterial target sites,
thus reducing the probability of generating resistance after
repeated use
Electron microscopy studies of the Gram-negative bacteria E.
coli exposed to ionic silver showed DNA condensation and loss
of replication activity, rupture of the bacterial wall, and release
of microbial content. X-ray studies demonstrated the presence
of silver ions inside the extensively damaged bacteria. Similar
changes occurred in Gram-positive microorganisms such as S.
aureus, following incubation with ionic silver.
[Feng QL et al 2000; Jung WK et al 2008]
Silver dressings that release ionic silver at bactericidal concen-
trations are associated with a low risk of inducing resistance in
target bacteria.
[White R et al 2006; Chopra I 2007]

AskinaCalgitrol_Scientific_Rationale_120503.indd 7 03.05.12 17:31

 Antimicrobial Activity

Figure 3. Antimicrobial activity of Askina® Calgitrol® Paste The ability of ionic silver to kill a large spectrum of Gram-positive,
- In vitro kill rates against (A) MRSA, (B) E. coli, and (C) P. Gram-negative, aerobic and anaerobic bacteria, as well as methi-
12
aeruginosa cillin-resistant S. aureus (MRSA) and vancomycin-resistant Entero-
10
12 coccus underlies its usefulness in the treatment of infected or at
Log (CFU) Reduction
8
risk wounds.
10
12
[Thomas S and McCubbin P 2003; Driver VR 2004; Weller C and Sussman G 2006]
6
8
10

4
6
8 In vitro testing has demonstrated the effectiveness of Askina®
Calgitrol® Paste against multiple Gram-positive and Gram-negative
2
4
6
bacterial strains including MRSA, P. aeruginosa, and E. coli.
0
2
4 [B. Braun; Reports HOSP 283A, 2011 and HOSP 303, 2011]
0,5 1 1,5 2 2,5 3 3,5 4 4,5 5 5,5 6 24
02
0,5 1 1,5 2 2,5 3 3,5 4 4,5 5 5,5 6 24 Askina® Calgitrol® Paste induced a 4-log reduction against MRSA
0 in 2 hours, and a >7 to >9-log reduction against E. coli and P.
//
0,5 1 1,5 2 2,5 3 3,5 4 4,5 5 5,5 6 24
Time
aeruginosa over a period of 3 hours. The Askina® Calgitrol® Paste
A. MRSA kill rates were similar to those for SSD, which is recognized as a
(hours)
12 standard of care for burns (Figure 3).
Log (CFU) Reduction
10
12
Resistance to topical silver has been addressed, but is of no im-
8
10
12 portance for clinical practice [Percival SL et al 2005]. Conversely,
6
8
10
substantial resistance rates have been induced by the sulfon-
amide component of SSD.
4
6
8 [Bridges K and Lowbury EJL 1977; Gupta A et al 1998; White RJ and Cooper R
2
4
6 2005]

0
2
4
0,5 1 1,5 2 2,5 3 3,5 4 4,5 5 5,5 6 24 Askina® Calgitrol® Paste demonstrates antimicrobial effec-
02
// tiveness against Gram-positive and Gram-negative strains
0,5 1 1,5 2 2,5 3 3,5 4 4,5 5 5,5 6 24
0 Time
B. E. coli
0,5 1 1,5 2 2,5 3 3,5 4 4,5 5 5,5 6 24
(hours)

Log (CFU) Reduction

12

10
12

8
10
12

6
8
10

4
6
8

2
4
6

0
2
4 //
0,5 1 1,5 2 2,5 3 3,5 4 4,5 5 5,5 6 24
02 Time
C. P. aeruginosa
0,5 1 1,5 2 2,5 3 3,5 4 4,5 5 5,5 6 24
(hours)
0
Askina Calgitrol Paste
® ®
0,5 1 1,5 2 2,5 3 3,5 4 4,5 5 5,5 6 24
Silver sulfadiazine

CFU, colony-forming units

 [B. Braun; Reports HOSP 283A, 2011 and HOSP 303, 2011]

AskinaCalgitrol_Scientific_Rationale_120503.indd 8 03.05.12 17:31

 Safety and Tolerability
Systemic Safety Local Tolerability

It is important to consider the potential risk of systemic and local
silver-related toxicity when envisioning use of a silver-containing
topical formulation. Substantial absorption of ionic silver can
lead to systemic silver toxicity, also known as argyria.
Argyria is usually associated with environmental exposure to
high quantities of silver and chronic overload (silver body burden
equal to 3.8 g or higher). Argyria is characterized by the deposi-
tion of inert silver in connective tissues, vessels, and the dermis,
and with potentially extensive discolouration of the skin and nail
beds, particularly in light-exposed areas.
[Lansdown AB 2010]
Skin contact studies have shown that Askina® Calgitrol® Paste
is well-tolerated after topical application, with little or no local
irritation. Its use is not associated with a significant risk of sen-
sitization and no staining of the skin surrounding the application
area has been reported in patients treated with Askina® Calgitrol®
Paste.
[B. Braun; Report HOSP 257, 2009]
Askina® Calgitrol® Paste is well-tolerated after topical ap-
plication, and systemic absorption of silver has been shown
to be very low.

Systemic absorption of silver and clinical argyria has been report-

ed with the use of SSD in patients with large area burns.
[Flamazine Cream Product Information; Smith & Nephew 2009]

In contrast, systemic absorption of silver from Askina® Calgitrol®

Paste has been shown to be insignificant in a preclinical model,
with blood serum silver levels remaining ≤ 0.012 ppm over a pe-
riod of 7 days (Figure 4).
[B. Braun; Report HOSP 257, 2009]

Up to almost 30 times higher blood silver levels (0.05 − 0.31 ppm)

have been detected in burns patients without signs of silver-
related toxicity.
[Wan AT et al 1991]

Figure 4. Leachable silver detected in the blood stream

Silver concentration (ppm)

0.36
Askina® Calgitrol® Paste
0.30

0.24

0.18
No evidence of toxicity in this range of silver concentrations
0.12

0.06

0
//
Day 1 Day 3 Day 7
Time
[NAMSA Report HOSP 257; Wan AT et al 1991] (days)

AskinaCalgitrol_Scientific_Rationale_120503.indd 9 03.05.12 17:31

 Appropriate Wound Types and
Application Instructions
Askina® Calgitrol® Paste is indicated for external use for the
management of
 Partial- to full-thickness wounds
 Stage I−IV pressure wounds
 Venous and arterial ulcers
 Diabetic foot ulcers
 Second-degree burns
The ease of use of Askina® Calgitrol® Paste makes it ideal for si-
nuses and tunnel wounds often seen in patients with burns, and
for other difficult-to-manage wounds, ie, diabetic foot ulcers. In
addition, the moisture donating properties of Askina® Calgitrol®
Paste may provide a soothing effect on burns.
Compatibility with a variety of secondary dressings and the po-
tential need for less frequent dressing changes contribute to the
versatility of Askina® Calgitrol® Paste and a potential reduction in
the burden of care for nursing personnel.
After cleansing the wound with 0.9 % saline or Prontosan® solu-
tion, the Askina® Calgitrol® Paste can be easily applied in a thick
layer to the entire wound bed. Askina Calgitrol® Paste is easily
removed with 0.9 % saline or Prontosan® solution, by simple rins-
ing.
Askina® Calgitrol® Paste should be reapplied at each dressing
change with a daily or up to three days frequency. A change may
also be advisable if wound exudates leak through the secondary
dressing.
Askina® Calgitrol® Paste should not be used in patients with
known hypersensitivity to alginates or silver, and in patients with
ulcers resulting from tuberculosis, syphilis, or deep fungal infec-
tions.
[Askina® Calgitrol® Paste Instructions for Use; B. Braun 2011]

In Summary
Askina® Calgitrol® Paste has a highly conformable product
form. This conformability allows for intimate contact between
the ionic silver alginate matrix and the wound bed; the prod-
uct helps to maintain a moist wound healing environment and
does not require any activation by water prior to use.
The silver alginate matrix provides effective, controlled, and
sustained release of active ionic silver and a broad antimicro-
bial activity over the entire wound bed area.
Askina® Calgitrol® Paste is an ideal formulation for difficult to
manage wound shapes, tunnel wounds, and small sinuses as
found in diabetic foot ulcers and second-degree burns.
Askina® Calgitrol® Paste is easy to apply and can be used with
a variety of secondary dressings including low adherent inter-
face and gauze types.

Askina® Calgitrol® Paste has an antimicrobial activity similar

to that of SSD without the emerging issues of antimicrobial
resistance and systemic toxicity.

10

AskinaCalgitrol_Scientific_Rationale_120503.indd 10 03.05.12 17:31

 References
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antimicrobial effectiveness and moisture binding properties of wound dressings.
Int J Mol Sci. 2010;11(8):2864-2874.
Askina® Calgitrol® Ag. Instructions for Use [P1067-00]. B. Braun Hospicare Ltd.
Sligo, Ireland; 2011.
Askina® Calgitrol® Paste. Instructions for Use [P1056-00]. B. Braun Hospicare Ltd.
Sligo, Ireland; 2011.
B. Braun. Measurement of serum silver from Askina® Calgitrol® Paste in a swine
dermal wound model. (Testing carried out by NAMSA); Report HOSP 257. B. Braun
Hospicare Ltd, 2009.
B. Braun. Determination of silver in Askina® Calgitrol® Paste to demonstrate pro-
duction homogeneity using Method Number G4AV. (Testing carried out by Shef-
field Analytical Services); Report HOSP 263, B. Braun Hospicare Ltd., 2008.
B. Braun. Log Reduction (LR) measure of efficacy of Askina® Calgitrol® Paste,
Flamazine Cream and Flaminal® Hydro against Cultures of P. aeruginosa (NCIMB
8626) and E. coli (NCIMB 12416) . (Testing carried out by Institute of Technology,
Sligo); Report HOSP 283A, B. Braun Hospicare Ltd., 2011.
B. Braun. Log Reduction (LR) measure of efficacy (results only) of Askina® Calgi-
trol® Paste and Flamazine Cream against a Culture of Methicillin Resistant Staph-
ylococcus aureus (MRSA, ATCC BAA-44). (Testing carried out by Institute of Tech-
nology, Sligo); Report HOSP 303, B. Braun Hospicare Ltd., 2011.
Bridges K, Lowbury EJL. Drug resistance in relation to use of silver sulphadiazine
cream in burns units. J Clin Pathol. 1977;30(2):160-164.
Chopra I. The increasing use of silver-based products as antimicrobial agents: a
useful development or a cause for concern? J Antimicrob Chemother.
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Driver VR. Silver dressings in clinical practice. Ostomy Wound Manage.
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client. Clin Interv Aging. 2009;4:269-287.
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Jung WK, Koo HC, Kim KW, Shin S, Kim SH, Park YH. Antibacterial activity and
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Lowbury EJ, Babb JR, Bridges K, Jackson DM. Topical chemoprophylaxis with silver
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Opasanon S, Muangman P, Namviriyachote N. Clinical effectiveness of alginate
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Int Wound J. 2010;7(6):467-471.
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Thomas S, McCubbin P. An in vitro analysis of the antimicrobial properties of 10
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11
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 B. Braun Hospicare Ltd. | Collooney | Co. Sligo | Ireland | www.bbraun.com ZJ01266 Edition: 05/2012

AskinaCalgitrol_Scientific_Rationale_120503.indd 12 03.05.12 17:31