Prontosan®

Wound bed preparation.

Taken seriously.
The Problem:

90
Biofilm
%
Traditional wound cleansing with saline or tap water can remove Over
loosely adherent foreign material but is ineffective at removing of chronic wounds have a biofilm present
coatings and debris in many wounds, especially complex biofilms.1 which is a major barrier to wound healing.2

What is a biofilm?
Biofilm forms when bacteria adhere to surfaces by excreting a thick, slimy, glue-like
substance known as the Extracellular Polymeric Substance (EPS)3,4.
This substance forms a protective layer, where the bacteria are no longer free to move
(planktonic), but adhere to the wound bed. A polymicrobial biofilm aggregate develops
under the protection of the EPS.5 Biofilms are often difficult to detect visually but they
are an important factor hindering the healing of chronic wounds.6

Bacteria protected from topical agents in a biofilm

Impaired migration and proliferation of keratinocytes
Bacteria protected from systemic antibiotics

How does biofilm develop?7

1
Contamination
Free floating bacteria attach to

1
a surface within minutes. Initial
attachment is reversible.

2
Colonisation
Bacteria multiply and become
firmly attached within 2 – 4 hours.

3
Biofilm development and
inflammatory host response
Develop initial EPS and become
increasingly tolerant to within
4 Biofilm
cycle 2
6 – 12 hours.

4
Spreading leads to systemic
infections
Mature biofilm releases bacteria
within 2 – 4 days causing
3
recolonisation, which results in
a never ending biofilm cycle.
2
 The Solution: Prevention and
management principles of biofilm
The prevention and management of biofilm in chronic wounds is rapidly
becoming a primary objective of wound care, with the presence of biofilm
acknowledged as a leading cause of delayed wound healing.6

Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel / Wound Gel X are one of few products specifically indicated
for the prevention and removal of biofilms. Prontosan® contains two key ingredients: Betaine and Polyhexanide.

Mode of action of Betaine8

A gentle effective surfactant (detergent) which is able to penetrate, disturb, clean and remove biofilm and wound debris.

1 Betaine Molecule
Hydrophilic head remains in solutions.
Hydrophobic tail is insoluble, detaches dirt/debris. 1 2 3
2 Reduces surface tension
Supporting softening, loosening and detaching of
dirt, debris and biofilm Hydrophilic head

3
Hydrophobic tail
Removes and holds in solution
Holds dirt, debris and biofilm in the solution,
preventing recontamination.

Mode of action of Polyhexanide (PHMB)

Promotes healing, minimises bioburden
Polyhexanide is a highly effective broad-spectrum antiseptic that is active against gram negative bacteria, including Pseudomonas
aeruginosa and gram positive bacteria, including Methicillin resistent staphylococcus aureus (MRSA), Vancomycin resistent Enterococci
(VRE), against yeast and others.9 Polyhexanide has been in general use for about 60 years, it has demonstrated good clinical safety
data (see overview page 5) with no evidence of resistance and very low toxicity.10 Polyhexanide has low to no absorption by human
cells and tissue, therefore interference with the metabolism of the body is negligible. Existing evidence shows that topical polihexanide
may promote healing of chronic stalled wounds, reduce bacterial burden, eliminate MRSA and alleviate wound related pain.11

Wound is cleansed, de-sloughed,

Biofilm present Mechanical rinsing with Betaine disrupts biofilm Polyhexanide as adjuvant debrided, decontaminated and
Wound Irrigation Solution (removes dirt and debris) anti­microbial free from biofilm

3
Prontosan® breaks the biofilm cycle
A proactive approach using a combination strategy of Recommendations on soaking time and
Prontosan® Wound Irrigation Solution and Prontosan® Wound product combination
Gel / Wound Gel X as part of wound bed preparation aims to: To achieve the best possible results, it
· Reduce the biofilm burden may be useful to consider the individual
(Prontosan® Wound Irrigation Solution) condition of the wound.12 The following
· Prevent reconstitution of the biofilm recommendations are based on an
(Prontosan® Wound Gel / Wound Gel X i ) observational study conducted in Italy.13

Chronic Wound - Epithelialising Cleanse - soak - cleanse with solution

· No slough · Cleanses the wound

· Low exudate · Helps to prevent biofilm
· Highly fragile 0–5 min
epithel tissue soak

Cleanse - soak - Apply

Chronic Wound - Granulating cleanse with solution Gel / Gel X i

· Light slough · Mechanically removes debris and

· Low/medium slough (ideally use the Prontosan®
exudate Debridement Pad) 5–10 min +
· Polihexanide has proven to promote soak
te

on
wound healing* 7 Ex nds Acti

Cleanse - soak - Apply

Chronic Wound - Exuding/Colonised cleanse with solution Gel / Gel X i

· Slough · Mechanically removes debris and

· Medium/high slough (ideally use the Prontosan®
exudate Debridement Pad) 10–15 min +
· Stalled wound · Polihexanide has proven to promote soak
te
on
Ex

wound healing* 7 nds Acti

· Reduction of odor

i Apply Prontosan® Gel in wounds with cavities, deep or tunneling wounds and difficult to access areas, Prontosan® Wound Gel X on larger surface wounds.

* in studies with Prontosan® Wound Irrigation Solution on Venous Leg Ulcers, Pressure Ulcers and Burns and with Prontosan® Wound Irrigation Solution &
Prontosan® Wound Gel (X) on chronic wounds like Diabetic Foot Ulcers, Venous Leg Ulcers or Pressure Ulcers, Surgical Wounds and Burns.

Once opened, Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel / Wound Gel X can be used for up to 8 weeks (single patient use).
4
Clinical Evidence
Study Type Conclusion
The results of this RCT with 289 subjects confirms the superiority of Prontosan® Wound
Bellingeri A. et al. (2016). Effect of a wound cleansing solution on wound bed
Irrigation Solution compared to Saline in efficacy as it promotes the wound bed preparation,
preparation and inflammation in chronic wound: a single-blind RCT, Journal of RCT
supports thereduction of inflammatory signs and accelerates the healing of vascular leg
Wound care
ulcers as well as pressure ulcers.

Romanelli M. et al. (2008). Evaluation of the efficacy and tolerability of a solution The results of the RCT with 40 subjects show that the pH value of the wound was
containing Betaine and PHMB in controlling the bacterial burden of chronic RCT significantly (p<0.05) lower and that pain control was achieved (p<0.05) in the Prontosan
wounds during wound bed preparation treatment group compared to the Saline group Saline group which was the control.

Both groups were comparable at the start of the study and the results obtained in the
final assessment of lesions were as follows: Reversal of positive cultures (p=0.004),
improvement in the healing process (p=0.000), reduction in lesion surface area (p=0.013);
improvement in granulated tissue % (p=0.001), reduction in the % of slough in wound beds
Valenzuela et al. (2008). The effectiveness of a 0.1% polyhexanide gel. Rev ROL
RCT (p=0.002), reduction of the presence of exudate (p=0.008), reduction of the presence of
Enf;31(4):247-52.
purulent exudate (p=0.005), improvement in the condition of surrounding skin (p=0.021),
reduction in pain (p=0.049), reduction in erythema in surrounding skin (p=0.004), reduction
in surrounding skin edema (p=0.000), reduction in surrounding skin warmth (p=0.004) and
reduction in odor (p=0.029).
If current thinking, that all chronic wounds are biofilm wounds (Wolcott and Rhoads,
2008), is sustained then we will need to rethink our approach to wound cleansing, as the
studies examined above indicate that PHMB, in conjunction with a surfactant, is superior
Cutting K. (2010). Addressing the challenge of wound cleansing in the modern
Review to isotonic solutions. In addition, there is evidence emerging that Prontosan is an effective
era, British Journal of Nursing, 2010 (Tissue Viability Supplement), Vol 19, No 11
wound cleanser in longstanding (chronic) wounds and has been found by patients to be
pain-free, improve patient quality of life, effectively manage wound infection and to reduce
the overall time to healing.
PHMB appears to meet the criteria for an ideal antimicrobial agent, as described by
Drosou et al (2003), and is available in presentations that provide clinicians with effective
Butcher M. (2012). PHMB: An effective antimicrobial in wound bioburden
Review woundcare modalities for most clinical scenarios. Clinical use, both in the UK and the
management, British Journal of Nursing (2012) 21:12 SUPPL. (16-21).
wider healthcare community, has shown PHMB-based wound-care products to be effective
options for managing wound colonisation and infection and, so, deserve closer scrutiny.
Sufficent MRSA eradication could be shown in vivo on patients for the non- cytotocic
Polyhexanide [...] In this article we discuss current therapeutic standards and potential
Dissemond J. et al. (2005). Methicilin-resistenter Staphylococcus aureus (MRSA) alternatives for eradication of MRSA. There is evident need for effective, novel approaches
Review
in chronischen Wunden, JDDG for elimination of MRSA from chronic wounds that avoid the development of bacterial
resistance; otherwise therapeutic alternatives for antibacterial treatment of chronic
wounds will become limited.
Wounds (Venous leg ulcers) of patients treated with Prontosan® Wound Irrigation Solution
Andriessen A, Eberlein T. (2008). Assessment of a wound cleansing solution in the Retro- healed significantly faster (p<0.0001) and in more cases (97% versus 89%) than the wounds
treatment of problem wounds, WOUNDS; 20(6):171-5 spective of patients treated with saline solution or Ringer’s solution. Additionally the infection rate
for the Prontosan group was lower (13% vs. 3%)
Treatment resulted in an improvement of 97% and a complete closure of 80% of the
Moller et al. (2008). Experiences in using polyhexanide containing wound
Retro- wounds. Infection rates declined from 40% to 3%. Prontosan® Wound Irrigation Solution
products in the management of chronic wounds – results of a methodical and
spective and Gel were compatible with various wound dressings, induced no skin irritations, reduced
retrospective analysis of 953 cases, Wundmanagement; 3:112-7.
odor and were accepted by the patients.
The results of this observational study showed that the treatment of skin wounds of
Durante et al. (2014). Evaluation of the effectiveness of a polihexanide and propyl various kinds and types, in different ages, from pediatric age, until the geriatric age , with
Obser-
betaine-based gel in the treatment of chronic wounds, Minerva Chirurgica; a polyhexanide and propyl betaine-based gel in combination with a secondary dressing
vational
69(5):283-92 showed significant improvements in the size of the wound, pain at dressing
change , and wound characteristics.
Saline solutions were less efficient than a betaine surfactant containing wound rinsing
solution in removing protein from adherent test wound coatings. Salt ions hinder the
hydration of proteins and decrease protein solubility. Prontosan® Wound Irrigation Solution
Kaehn et al. (2009). In-vitro test for comparing the efficacy of wound rinsing solubilized denatured proteins and aggregated by inclusion in betaine surfactant micelles.
In-vitro
solutions, British Journal of Nursing This is an essential property for thorough and gentle wound cleansing. Wound progress
of leg ulcers was more postitive when the wound was treated with Prontosan® Wound
Irrigation Solution comapred with saline solution. The wound antiseptic Octenisept did not
seem suitable for wound cleansing because proteins were denatured and became insoluble.

Lopez-Rojas et al. (2016). In vitro activity of a polyhexanide-betaine solution Prontosan® Wound Irrigation Solution has high bactericidal activity against the studied
against high-risk clones of multidrug resistant nosocomial pathogens, Enferm In-vitro multidrug-resistant pathogens. Furthermore, this bactericidal activity occurs rapidly (1
Infecc Microbiol Clin 35 (1), 12-9. min), within a much shorter period of time than that recommended by the manufacturer.

Due to the cytotoxic effect of some antiseptics on human skin cells, it is advised that health
care professionals balance the cytotoxicity of the medication, their antiseptic properties,
Hirsch et al. (2010). Evaluation of Toxic Side Effects of Clinically Used Skin
In-vitro and the severity of colonization when selecting a wound care antiseptic. Lavasept and
Antiseptics In Vitro, Journal of Surgical Research Volume 164, Issue 2
Prontosan® Wound Irrigation Solution showed best result regarding antibacterial efficacy
and cell toxicity, and should therefore be favored in clinical wound care.

As far as the clinical practice of biofilm removal based on moist management practices
Seipp et al. (2005). Efficacy of various wound irrigants against biofilm, ZFW;
In-vitro is concerned, our investigations attest to the superior efficacy of the surfactant and
4: 160-4.
polyhexanide solution compared with isotonic saline or Ringer’s solution.

5
Wound bed preparation. Taken seriously.
The clinical evidence demonstrates that by routinely
introducing a Prontosan® regime as part of your patient
pathway you can achieve better result.

· Improved patient outcomes, including time to heal14

· Helps to prevent complications13,15
· Can help to reduce antimicrobials and antibiotics16

How Prontosan®
might save you money
In a model calculation for the UK, based on the average
reduction in treatment time of patients with Venous
Leg Ulcers, the cost saving from changing to the
Prontosan® regime compared to saline is, on average,
£ 867.87 per patient over a time horizon of one year.17

Breakdown of wound care costs18 Cost drivers How Prontosan® can help to reduce costs

· Increased number of · Infection rates reduction with Prontosan® Wound

Irrigation Solution & Prontosan® Wound Gel *
40% Inpatient costs hospital days
· Inflammatory signs reduced with Prontosan® Wound
· Complication rates
Irrigation Solution**

· Treatment reduction from 17 to 13 weeks with

Prontosan® Wound Irrigation Solution***
40% Nursing time · Length of treatment time
· Wound size reduction. BWAT Score p=0.049. Granula-
tion tissue improvement. BWAT Score p=0.04314

· Cost of dressings
· Reduction in dressing change frequency of 55% in
20% Dressing · Frequency of dressing
hard-to-heal wounds19
changes

BWAT = Bates-Jensen Wound Assessment Tool

* in Diabetic Foot Ulcers, Leg Ulcers, Pressure Ulcers, Radiotherapy damage (oncology patients). 20
** in Venous Leg Ulcers and Mixed Ulcers (BWAT Score p=0.0043). 21
*** on Venous Leg Ulcers. 22

Helping compliance | At B. Braun we recognize the benefits of implementing a standardised approach to providing a better
level of care and outcome. When implementing a Prontosan® pathway we will support you by providing educational packages to
ensure compliance and to support your required educational needs.

6
Quality of life case study extracts
“The use of Prontosan® Wound Irrigation Solution and Wound Gel X
contributed to the speedy healing of these diabetic wounds by reducing
bioburden. Their use enabled the painless removal of sloughy tissue
within one week. The patient spoke of increased confidence that his
wounds would heal, directly as a consequence of using Prontosan®.”

Butters V, McHugh J. A Case Report On The Use Of A Moistening, Cleansing, Surfactant Irrigation Solution And Gel On
A Traumatic Wound On A Diabetic Patient In A Busy Acute Department. European Wound Management Association
(2012): 481.
07/07/2010 03/09/2010

“The patients quality of life improved with a reduction in pain and

reduction in exudate level with Prontosan® Wound Gel in chronic
wounds requiring only weekly dressings. Her mobility increased and she
could begin to walk short distances again, allowing her to go out and
resume normal social activities. The cost of wound management was
reduced with only weekly visits by district nurses being required, com-
pared to daily visits prior to intervention, and through reduced use of
antibiotics”
Ovens L. Removal Of Biofilm In Infected Venous Leg Ulcers Using Prontosan® Wound Irrigation Solution And Gel.
European Wound Management Association (2010) 03/09/2009 10/12/2009

“The benefits in terms of increased quality of life for this patient

cannot be underestimated and as a result of the successful wound
management this lady has now started to swim again, is looking for-
ward to a holiday abroad with friends and most importantly is now being
considered for the renal transplant list.”
Hughes N. Calciphylaxis – A Successful Outcome In Wound Management Using Prontosan. European Wound Manage-
ment Association (2008)
01/04/2008 10/06/2008

“Historically, daily visits from the district nursing staff commenced in Ulcer 1 Ulcer 1
January 2001 and took one hour per day. Both the patient and his family
found the visits a necessity but they felt that their lives revolved around
treating the ulcers. Since commencing Prontosan®, visits from the dis-
trict nurse were reduced to alternate days and the patient and his wife
attended their son’s wedding, with no detrimental effect to either ulcer.
This was the first time the patient had left his house to attend a 12/04/2006 14/04/2006
social occasion for over 5 years. It has made significant improvements Ulcer 2 Ulcer 2
to both wounds which the patient, his wife and district nursing service
did not expect to see. This has improved the patient’s morale and the
results have motivated all nursing staff.”
Horrocks A. Successful Treatmen of two grade 4 pressure ulcers of 5 years duration using Prontosan® Solution and
Gel. European Wound Management Association (2006)

17/02/2006 17/03/2006
7
Prontosan® Wound Irrigation Solution and
Wound Gel / Wound Gel X
Ordering Information
Product Description Size Pack Size Product Code
Prontosan® Wound Irrigation Solution 40 ml ampoule 24 400484
350 ml bottle 10 400403
1000 ml bottle 10 400446
Prontosan® Wound Gel 30 ml pod 20 400505
Prontosan® Wound Gel X 50 g tube 20 400517
250 g tube 20 400508

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2. Attinger C, Wolcott R. Clinically Addressing Biofilm in Chronic Wounds. Adv Wound Care (New Rochelle). 2012 Jun;1(3):127-132. doi: 10.1089/wound.2011.0333. PMID: 24527292;
PMCID: PMC3839004.
3. Alves PJ, Barreto RT, Barrois BM, Gryson LG, Meaume S, Monstrey SJ. Update on the role of antiseptics in the management of chronic wounds with critical colonisation and/or
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Minerva Chir. 2014;69(5):283-92.
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10. Hirsch T, Koerber A, Jacobsen F, Dissemond J, Steinau HU, Gatermann S, Al-Benna S, Kesting M, Seipp HM, Steinstraesser L. Evaluation of toxic side effects of clinically used skin
antiseptics in vitro. J Surg Res. 2010 Dec;164(2):344-50. doi: 10.1016/j.jss.2009.04.029. Epub 2009 May 18. PMID: 19726054.
11. To E, Dyck R, Gerber S, Kadavil S, Woo KY. The Effectiveness of Topical Polyhexamethylene Biguanide (PHMB) Agents for the Treatment of Chronic Wounds: A Systematic Review.
Surg Technol Int. 2016 Oct 26;29:45-51. PMID: 27608742.
12. Gist S, Tio-Matos I, Falzgraf S, Cameron S, Beebe M. Wound care in the geriatric client. Clin Interv Aging. 2009;4:269-87. doi: 10.2147/cia.s4726. Epub 2009 Jun 9.
PMID: 19554098; PMCID: PMC2697592
13. Ricci E. Cleansing versus tailored deep debridement, a fresh approach to wound cleansing: an Italian experience. J Wound Care. 2018 Aug 2;27(8):512-518. doi: 10.12968/
jowc.2018.27.8.512. PMID: 30086255.
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