Prontosan® Wound Bed Preparation

Prontosan® Wound bed preparation. Taken seriously. The Problem - Biofilm

THE PROBLEM WHAT IS A BIOFILM? Traditional wound cleansing with saline Biofilm forms when bacteria adhere and water is ineffective at removing to surfaces by excreting a thick, slimy, coatings and debris in many wounds, glue-like substance known as the especially complex biofilms. Extracellular Polymeric Substance (EPS). FACT: Over 90% of chronic wounds have This substance forms a protective a biofilm present which is a major barrier layer, where the bacteria are no longer 1 to wound healing . free to move (planktonic), but adhere to the wound bed. New bacteria are OVER produced and the colony grows under Bacteria protected from topical the protection of the EPS. agents in a biofilm Bacteria protected from systemic Biofilms are often difficult to detect antibiotics visually but delay wound healing due Impaired migration and proliferation 90% to the protection they provide to the of keratinocytes OF WOUNDS HAVE A BIOFILM1 bacteria in the wound bed2.

HOW DO BIOFILMS DEVELOP?2

CONTAMINATION Free floating bacteria attach to a surface within minutes. Initial attachment is reversible.

SPREADING LEADS TO COLONISATION SYSTEMIC INFECTIONS Bacteria multiply and Mature biofilm, extremely become firmly attached resistant to biocides and within 2 – 4 hours. releases bacteria within 2 – 4 days causing recolonisation, BIOFILM CYCLE which results in a never ending biofilm cycle.

BIOFILM DEVELOPMENT AND INFLAMMATORY HOST RESPONSE develop initial EPS and become increasingly tolerant to antibiotics, antiseptics and disinfectants within 6 – 12 hours. 2 The Solution - Prevention and Management Principles of Biofilm

THE SOLUTION 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 healing3. Prontosan® Solution and Prontosan® Gel X are one of few products specifically indicated for the prevention and removal of biofilms. Prontosan contains two key ingredients:Betaine and Polyhexanide.

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

BETAINE MOLECULE REDUCES SURFACE TENSION REMOVES AND HOLDS IN SOLUTION

Hydrophilic head remains in solutions Hydrophobic tail is insoluble, detaches dirt/debris

Supporting softening, loosening and detaching of Holds dirt, debris and biofilm in the solution, dirt, debris and biofilm helping to prevent recontamination.

POLYHEXANIDE (PHMB) Promotes Healing, Minimises Bioburden

PHMB is a highly effective broad spectrum antimicrobial that is active against gram negative and gram positive bacteria, fungi and yeast, including MRSA, Pseudomonas aeruginosa, VRE etc. PHMB has been in general use for about 60 years; it has demonstrated good clinical safety data with no evidence of resistance and minimal toxicity. PHMB is not absorbed by human cells and tissue, therefore it cannot interfere with the metabolism of the body.

Biofilm present Prontosan application Betaine disrupts biofilm PHMB solution destroys Wound is cleansed, (removes dirt and debris) bacteria de-sloughed, debrided, decontaminated and free from biofilm 3 Prontosan® Breaks the Biofilm Cycle

A proactive approach using a combination strategy of Prontosan Solution and Prontosan Gel X as part of wound bed preparation may prove helpful and aims to: ® ®  Reduce the biofilmProntosan burdenProntosan ® Solution Solution Prontosan(Prontosan® Solution Solution)  PreventProntosan reconstitution of the biofilm Solution(Prontosan Gel X) APPROPRIATEAPPROPRIATE TIME TIME FOR FOR APPROPRIATE APPROPRIATE WOUND WOUND APPROPRIATE TIME FOR APPROPRIATE WOUND AppropriateAPPROPRIATE Time for Appropriate TIME Wound FOR APPROPRIATE WOUND DESCRIPTION OF WOUNDDESCRIPTIONDESCRIPTION OF WOUND OF WOUNDOBJECTIVE HOW TOHOW USE HOWTO USE TO USE DESCRIPTION OF WOUND ® HOW TO USE ACUTE DESCRIPTIONWOUND - SURGICALProntosanACUTE OF WOUND PRIMARY ACUTEWOUND WOUND &- SURGICALSECONDARY - SURGICAL SECONDARY INTENTIONSolution SECONDARY INTENTION HEALING INTENTION HEALING HOWHEALING TO USE Rinse with Solution ACUTE WOUND - SURGICAL SECONDARY INTENTION HEALING ACUTE WOUND - SURGICAL SECONDARY INTENTION HEALING  High risk patient*  High Risk High Patient* Risk Patient*  Cleans APPROPRIATE TIME FOR APPROPRIATE WOUND Irrigate Irrigate  No slough  No Slough  Helps to prevent biofilm/ wound  High Risk Patient* No Slough wound  High Risk Patient* Irrigate  Minimal No exudate Slough  Minimal Minimal Exudate Exudate complications  No Slough Irrigatewound  Minimal Exudate wound  Minimal ExudateDESCRIPTION OF WOUND HOWSoak TO withUSE Consider ACUTE WOUND e.g. traumaACUTE ACUTEWOUND WOUND e.g. trauma e.g. trauma ACUTE WOUND - SURGICAL SECONDARY INTENTION HEALING Solution Debridement ACUTE WOUND e.g. trauma ACUTE WOUND e.g. trauma  Cleans  Debris 0 - 5 mins   HighDebris Risk Patient*  0 - 5 mins Debris Helps to prevent biofilm/ soak+  Haematoma Irrigatesoak  Haematoma Debris  NoHaematoma Slough complications  Debris 0 - 5 mins wound  Haematoma Minimal Exudate  Removes debris 0 - 5soak mins  Haematoma soak CHRONICCHRONIC WOUND WOUND - GRANULATING - GRANULATING Soak with Consider CHRONIC WOUND - GRANULATINGACUTE WOUND e.g. trauma CHRONIC WOUND - GRANULATING Solution Gel X CHRONIC WOUND - GRANULATING

 High Risk Patient* 0 - 5 mins  High Risk Patient*  0 - 5 mins Cleans soak  High risk patient*  Debris Low Exudate 0 - soak5 mins  High Risk Patient* Low Exudate  Helps to prevent biofilm/ 0 - 5 mins +    Haematoma soak Low exudate High Risk Patient* 0 - 5soak mins Low Exudate complications soak 2 n  Low Exudate 4/7 Actio CHRONICCHRONIC WOUND WOUND CHRONIC WOUND - GRANULATING Soak with Consider Apply CHRONICCHRONIC WOUND WOUND CHRONIC WOUND Solution Debridement Gel X  Cleans  Light slough 5 - 10 mins  Light slough 5 - 10 mins  High Risk Patient*  Helps to prevent, disrupts soak  Light slough Light slough Low exudate Low exudate 0 -soak 5 mins  Light slough Low Exudate & removes biofilm/ 5 - 10 mins + soak +  Low exudate Low exudate 5 - 10soak mins  Low exudate complications soak 2 n  Removes slough & debris 4/7 Actio CHRONICCHRONIC WOUND WOUND - CRITICALLY - CRITICALLY COLONISED/INFECTED COLONISED/INFECTED CHRONIC WOUND Soak with Apply CHRONICCHRONIC WOUND WOUND - CRITICALLY - CRITICALLY COLONISED/INFECTED COLONISED/INFECTED Debride CHRONIC WOUND - CRITICALLY COLONISED/INFECTED Solution Gel X  Medium Medium / High Exudate/ High Exudate 10 - 15 mins   Cleans 10 - 15 mins   Static WoundStatic Wound soak Medium / High LightExudate slough 5 - 10soak mins  Medium/high Medium exudate / High Exudate Slough  Helps to prevent, disrupts 10 - 15 mins  Static Wound LowSlough exudate soak  Static woundStatic Wound & removes biofilm/ 10 - soak15 mins + +  Slough soak  Slough Slough complications *High risk patient: Co-morbidities such as Diabetes, immuno-compromised, steroidal use, patients with previous wound infection and or biofilm and slough. 24 ion *High risk patient: Co-morbidities such as Diabetes, immuno-compromised, Removes steroidalslough use, & patients debris with previous wound infection and or biofilm and slough. /7 Act *High risk patient: Co-morbiditiesCHRONIC such as Diabetes, WOUND immuno-compromised, - CRITICALLY steroidal COLONISED/INFECTED use, patients with previous wound infection and or biofilm and slough. *High risk patient:*High risk Co-morbidities patient: Co-morbidities such as Diabetes, such as immuno-compromised, Diabetes, immuno-compromised, steroidal use, steroidal patients use, with patients previous with wound previous infection wound and infection or biofilm and andor biofilm slough. and slough. ® ® ® ® Compatible with other dressings.For even ForOnce evenbetter opened, better Prontosanresults, results, Solution apply apply andProntosan Gel XProntosan can be Gelused forX Gel afterup to X 8 after usingweeks (singleusing Prontosan patient Prontosan use). Solution. Solution.  Medium / High Exudate ® ® For moreFor information even better on Prontosan results,® Debridement apply PadProntosan please contact® Gel your X local after sales using representative Prontosan or call ®our Solution. freephone10 - number15 mins 0800 093 0100. For even better results, Static Wound apply Prontosan Gel X after using Prontosan Solution. soak  4 Slough FREEPHONE FREEPHONE NUMBER NUMBER 0800 0800 093 093 0100 0100 *High risk patient: Co-morbidities such as Diabetes, immuno-compromised, steroidal use, patients with previous wound infection and or biofilm and slough. FREEPHONE NUMBER 0800 093 0100 B. Braun Medical Ltd | OPM | Thorncliffe Park | Sheffield | S35 2PW For even better results, applyB. Braun Prontosan Medical® LtdGel | OPMX after | Thorncliffe using Prontosan Park | Sheffield® Solution. | S35 2PW B. Braun Medical Ltd | OPMTel 0114 | ThorncliffeTel 225 0114 9000 225 Park| 9000Fax | 0114 Sheffield| Fax 225 0114 9111 | 225 S35 | www.bbraun.co.uk9111 2PW | www.bbraun.co.uk B. Braun Medical Ltd | OPM | Thorncliffe Park | Sheffield | S35 2PW Tel 0114 225 9000 | Fax 0114 225 9111 | www.bbraun.co.uk XX-PIFUT-06-16 Tel 0114 225 9000 | Fax 0114 225 9111 | www.bbraun.co.uk XX-PIFUT-06-16 XX-PIFUT-06-16 FREEPHONE NUMBER 0800 093XX-PIFUT-06-16 0100

XX-PIFUT-06-16 Clinical Evidence - Summaries and Extracts

STUDY TYPE EXTRACT

Bellingeri A, Falciani F, Traspedini P, Moscatelli A, Russo A, Tino G, 289 patients with pressure ulcers or vascular leg ulcers, treated with either Chiari P (2016) Prontosan or Saline. Data analysis showed significant differences. The BWAT RCT Effect if a wound cleansing solution on wound bed preparation and total score for inflammatory = 0.03: BWAT scores for wound size reduction inflammation in chronic wound: a single-blind RCT. (p=0.049) and granulation tissue improvement (p=0.043) in favour of Prontosan.

Romanelli M (2008) 40 patients with colonized, critically colonized and infected venous leg ulcers. Evaluation of the efficacy and tolerability of a solution containing 20 patients were treated with Prontosan and 20 patients treated with saline at RCT Betaine and PHMB in controlling the bacterial burden of chronic each dressing change. The Prontosan group showed a significantly better control wounds during wound bed preparation. of bacterial burden.

The article compares PHMB, octenidine and placebo. They found in the early Kramer A, Roth B, Muller G, Rudolph P, Klocker (2004) stages of wound healing octenidine retarded wound contraction where as in Influence of antiseptic agents Polyhexanide( PHMB) and Octenidine on RCT the later stage PHMB significantly promoted wound closure. Complete wound FL cells and on healing of experimental superficial aseptic wounds in closure achieved with PHMB, 22.9 days, placebo 24.1 days and octenidine 28.3 piglets. days.

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 Valenzuela AR, Perucho NS (2008) cultures improvement in the healing process, reduction in lesion surface area, Clinical evaluation of the e cacy of 0.1 % polyhexanide gel (Prontosan improvement in granulated tissue, reduction in the percentage of slough in Wound Gel) verses the GNEAUPP and AHCPR recommendations for RCT wound beds, reduction of the presence of exudate, reduction of the presence of cleaning and debridement in the control of bacterial burden in chronic purulent exudate, improvement in the condition of surrounding skin, reduction wounds. in pain, reduction in erythema in surrounding skin , reduction in surrounding skin oedema, reduction in surrounding skin warmth and reduction in odour.

Andriessen A, Eberlein T (2008) Infection rates were reduced to 3% using Prontosan versus 13% saline/ringers Assessment of a wound cleansing solution in the treatment of problem Cohort group. Prontosan also healed wounds quicker in a time of 3.31 months compared wounds. to 4.42 months.

Results of a methodical and retrospective analysis of 953 patients. Wound Moller A, Nolte A, Kaehn K (2004) infection rate fell from 40% to 3%, and 80% of the wounds healed to wound Experiences with the use of PHMB-containing wound products in the Cohort closure. Cost savings were made through less frequent use of antibiotics, silver management of chronic wounds. dressings and through longer intervals between dressing changes. Davis S (2007) Determination of the effects of Prontosan irrigation solution on MRSA biofilms Determination of the effects of Prontosan Irrigation Solution on MRSA Animal in a partial thickness porcine wound model. and biofilms in a partial thickness porcine wound model.

The aim of this study was to test the efficacy of Saline, Ringers, Prontosan and Kaehn K, Eberlein T (2009) Ocenisept to solubilize and remove wound coatings using a wound coating In-vitro model. Prontosan was the only solution where the test coatings disintegrated In-vitro test for comparing the efficacy of wound rinsing solutions. and the denatured proteins solubilized. The test coatings became fixed and insoluble when immersed in Octenisept.

Lopez-Rojas R, Fernández-Cuenca F, Serrano-Rocha L, Pascual Á (2016) Prontosan is effective against wound pathogens in less that 14 minute with no In-vitro In vitro activity of a polyhexanide-betaine solution against high-risk development of resistance observed. clones of multidrug resistant nosocomial pathogens.

The agents tested showed effective antibacterial (Prontosan, Lavasept and Octenisept showed higher efficacy than Braunol and Betaisodona). Prontosan Hirsch, T et al. (2009) and Lavasept demonstrated less toxicity on primary human fibroblast and In-vitro keratinocytes, whereas Octenisept, Betaisodon, and Braunol showed a Evaluation of toxic side effects of clinically used skin antiseptics. significant decrease in cell viability. It is advised the balance of cytotoxicity and the antiseptic properties are considered when selecting a product, in the study Prontosan and Lavasept showed the best result for this.

This study tested Prontosan, Saline and Ringers in there efficacy against biofilm Seipp H M, Hofmann A, Hack A, Skowronsky A, Hauri A (2005 – 2007) of Pseudomonas Aeruginosa. Baseline biofilms were unaffected by Ringers and In-vitro Efficacy of various wound irrigants against biofilm. Saline but Prontosan reduces biofilm with no adverse affects enabling healing to take place.

5 Wound Bed Preparation. Taken Seriously.

The clinical evidence demonstrates that by routinely introducing a Prontosan® regime as part of your patient pathway you will achieve a better result.

 Improved patient outcomes, including time to heal

 Helps to prevent complications

 Reduces spend on antimicrobials and antibiotics

How Prontosan Saves You Money 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, £400 per patient8.

Breakdown of wound Cost drivers How Prontosan reduces costs care costs5

 Infection rates reduced from 40% to 3%6  Increased number of bed days Inpatient costs  Inflammatory signs reduced. BWAT Score p=0.00437 40%  Complication rates  Decrease in incidence of reduction in bacterial counts9

 Treatment time reduced from 17 to 13 weeks8 40% Nursing time  Length of treatment time  Wound size reduction. BWAT Score p=0.049. Granulation tissue improvement. BWAT Score p=0.0437

 Cost of dressings  Fewer dressing changes6 Dressing 20%  Frequency of dressing changes  Fewer silver dressings6

Helping compliance

At B. Braun we recognise 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 Solution and Gel 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 and 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 a reduction in exudates levels 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, compared 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 ofincreased 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 forward to a holiday abroad with friends and most importantly is now being considered for the renal transplant list.”

Hughes, Nicola. “Calciphylaxis – A Successful Outcome In Wound Management Using Prontosan”. European Wound Management Association (2008) 01/04/2008 10/06/2008

“Historically, daily visits from the district nursing staff commenced Ulcer 1 Ulcer 1 in 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 district 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 12/04/2006 14/04/2006 patient had left his house to attend a social occasion for over Ulcer 2 Ulcer 2 5 years. It has made significant improvements 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® Solution and Gel X Ordering Information

Product Description Size Pack Size Product Code PIP Code NHSSC Code

40 ml ampoule 24 400484 374-5940 ELY424 350 ml bottle 10 400403 324-8572 ELY248 Prontosan Solution 1000 ml bottle 10 400446 402-8544 ELY618 Adapter for NPWT 10 3908437 - ELZ980

Prontosan Gel 30 g 20 400505 324-8598 ELZ213

50 g tube 20 400517 378-1796 ELZ542 Prontosan Gel X 250 g tube 20 400508 367-8612 ELZ396

Pack of 3 pads 3 3908456 406-9290 ELZ887 Prontosan Debridement Pad Pack of 10 pads 10 3908457 406-9282 ELZ888

TO FIND OUT MORE PLEASE VISIT: www.bbraun.co.uk

OR CALL OUR FREEPHONE NUMBER ON: 0800 093 0100

XX-PPB-08-19

REFERENCES: 1. Attinger, Christopher and Randy Wolcott. “Clinically Addressing Biofilm In Chronic Wounds”. Advances in Wound Care 1.3 (2012): 127-132. Web. 2. Phillips, PL et al. “Biofilms Made Easy”. Wounds International 1.3 (2016): 1-6. Web. 3. Bjarnsholt, T et al. “Biofilm Management”. 2016. Lecture. 4. Bradbury, S and J Fletcher. “Prontosan Made Easy”. Wounds International 2.2 (2016): 1-6. Web. 23 Sept. 2016. 5. Drew, Philip, John Posnett, and Louise Rusling. “The Cost Of Wound Care For A Local Population In England”. Int Wound Journal 4.2 (2007): 149-155. Web. 6. Moller A, Kaehn K, Nolte A. Experiences with the use of polyhexanide-containing wound products in the management of chronic wounds — results of a methodical and retrospective analysis of 953 patients. Wound Management, 2008; 3: 112-117. 7. Bellingeri, A. et al. “Effect Of A Wound Cleansing Solution On Wound Bed Preparation And Inflammation In Chronic Wounds: A Single-Blind RCT”. Journal of Wound Care 25.3 (2016): 160-168. Web. 8. Andriessen, AE and T Eberlein. “Assessment Of A Wound Cleansing Solution In The Treatment Of Problem Wounds”. Wounds 20.6 (2008): 171-175. Web. 23 Sept. 2016. 9. Collier, Mark. “Evidence Of The Reduction Of Hospital Acquired Infections (HCAI’S) Following The Introduction Of A Standard Antimicrobial Wound Cleansing Solution To All Surgical Areas Within A Large Acute NHS Trust In The UK”. Wounds UK (2014).