1. Prontosan® solution/gel
... lavasepsis of chronic & acute wounds and burns
FIRST WOUND HYGIENE- THEN WOUND TREATMENT
optimal wound conditioning
fast and effective removal of wound coatings and biofilm
accelerated wound healing
absorption of wound odours
can be used up to 8 weeks after opening
2. “Wound bed preparation: science
applied to practice”
V. Falanga
EWMA Position Document, London: MEP Ltd. 2004.
TIME Framework
There are four components to wound bed
preparation, which address the different
pathophysiological abnormalities underly-
ing chronic wounds:
T - Tissue management
I - Inflammation and infection control
M - Moisture balance
E - Epithelial/edge/ advancement
What is the significance of the TIME
framework?
• Its practical significance involves opti-
mum wound bed preparation by redu-
cing inflammation, exudates, bacterial
burden and, importantly, correcting the
abnormalities contributing to impaired
healing. This, in turn, should facilitate
the normal endogenous process of wo-
und healing.*
• The TIME framework can be used to eva-
luate the role of therapeutic interven-
tions. A single intervention can impact
more than one element of TIME, for
example, debridement will not only re-
move wound coatings but will also redu-
ce the bacterial load.
Inflammation and infection control
• There is no question that clinical wound
infection resulting in failure to heal must
be treated promptly and effectively.
• Evidence shows that bacteria contained
in the biofilm become easily resistant to
antimicrobials.
• Intensive investigation is needed to de-
termine the role of biofilms in delayed
wound healing.
(*(“providing the underlying intrinsic and extrinsic
factors affecting wound healing have also been ad-
dressed”) )
“Management of wound infections”
CJ Moffatt, P Bowden, RA Cooper
EWMA Position Document, London: MEP Ltd. 2006.
• A wound does not have to be sterile to
progress towards healing.
• The use of topical antiseptics simply to
lower microbial load in the healing wo-
und can never be justified.
• Adverse microbial involvement in de-
layed healing must be suspected when
other causes have been eliminated.
• Although antiseptics play a major role in
the reduction of infection during surgi-
cal procedures and preoperative prophy-
laxis (preoperative skin disinfection), in
the case of closed surgical wounds, their
use in the prevention and treatment of
infections is unjustified and, so far, no
investigations have proven their effecti-
veness in this respect.
RECOMMENDATIONS OF THE EUROPEAN WOUND
MANAGEMENT ASSOCIATION (EWMA)
3. LAVASEPSIS
E.g. betaine/PHMB solution, gel (Exemplary
Products: Prontosan® solution, Pronto-
san® gel).
Mode of action: physical removal of wo-
und coatings and biofilm using a detergent
solution.
APPLICATION:
• For every type of surface wound.
• Fast and effective removal of wound co-
atings and biofilm (WOUND HYGIENE).
• Infection prophylaxis (CHRONIC USE).
• Rationalisation and restricted use of an-
tibiotics and antiseptics.
• Reduction of drug resistance develop-
ment.
• Obtaining an optimal therapeutic effect
of the procedures, dressings and medici-
nes used (including antiseptics and anti-
biotics).
• Acceleration of wound healing
NOTES:
• It cannot replace antisepsis
ANTISEPSIS
E.g. octenidine/phenoxyethanol, PVP-i-
odine silver dressings (Exemplary Products:
Braunol®, Braunovidon®).
Mode of action: kill or inactivate microor-
ganisms in the wound.
APPLICATION:
• Treatment of infected wound (SHORT-
TERM APPLICATION).
• Perioperative infection prophylaxis.
• Disinfection of traumatic wounds (wo-
und rinsing).
NOTES:
• Impediment of wound healing.
• Do not use in the prevention of chronic
and closed surgical wound infections
• Do not use in wound hygiene: wound
cleansing and biofilm removal
IRRIGATION
E.g. physiological saline solution, Ringer
solution (Exemplary Products: Ecolav®).
Mode of action: physical removal of wound
coatings, moistening.
APPLICATION:
• Irrigation of all types of wounds (NO
TIME CONSTRAINTS).
• Perioperative wound irrigation.
• Irrigation of traumatic wounds.
• Flushing out antiseptics from the wound
after disinfection.
• Dressing moistening.
NOTES:
• Removal of wound biofilm or thorough
cleansing of chronic wound is not possi-
ble in practice due to absence of a deter-
gent action.
LAVASEPSIS, ANTISEPSIS, IRRIGATION
Wound application according to TIME (overview)
LAVASEPSIS T I M E
ANTISEPSIS T I M E
IRRIGATION T I M E
4. Wound Lavasepsis
… the easiest way to effective topical wound treatment
application of Prontosan® solution in routine wound management
5. Optimal wound bed preparation is essen-
tial for ensuring effective application of a
therapeutic strategy corresponding to the
wound healing stage. Only then can wo-
und-treatment measures (e.g., dressing,
systemic antibiotic, antiseptic, bioactive
product) or methods (e.g., debridement,
skin transplantation) fully disclose their
therapeutic potential.
The biofilm problem
If a wound is colonised, i.e., there are a
number of germs on the wound surface,
the metabolic products of these bacteria
produce the so called, biofilm. This biofilm
protects the bacteria from extrinsic envi-
ronmental factors, and, consequently, from
the effect of antibiotics and antiseptics.
The biofilm facilitates undisturbed proli-
feration of the bacteria it protects and at
the same time acts as a docking station for
other bacteria. As a result, there is a signi-
ficant drop in the effectiveness of topical
and systemic therapeutic measures.
Wound lavasepsis
Components of a lavaseptic (Prontosan®)
reduce the surface tension of the aqueous
solution permitting penetration and ef-
fective removal of the biofilm, even in the
case of fissured wounds.
As a consequence the wound is cleansed
thoroughly.
Lavasepsis
Traditional wound irrigation
6. Prontosan®
state-of-the-art in lavasepsis
REPORTS FROM SELECTED COMPARA-
TIVE STUDIES
Wound cleansing through removal of fi-
brin coatings and exudate
The study investigated the cleansing pro-
perties of solutions used in chronic wound
treatment: Prontosan® solution, physio-
logical saline, Ringer solution, Lavanid® 1
and octenidine/phenoxyethanol solution.
A model simulating the practical condi-
tions occurring on a contaminated wound
was used. Prontosan® solution demonstra-
ted definitely the best cleansing properties.
Prontosan® easily dissolved test deposits
and released the proteins contained within.
Lavanid® 1 solution dissolved coatings
with a ca 10% lower effectiveness and
the dissolution process was considerably
slower. The next product with the highest
effectiveness was physiological saline, fol-
lowed by Ringer solution. The application
of octenidine/phenoxyethanol solution
caused immediate denaturation of the de-
posit proteins leading to its decolouration
and denaturation. For this reason, the pro-
duct is not suitable for the separation and
removal of organic debris from the wound
surface.
Kurt Kaehn, Zeitschrift fur Wundeheilung No. 1, 2007,
p 12-17 and unpublished data
Biofilm removal
Comparative study on the efficacy of Pron-
tosan® solution,physiological saline and
Ringer solution in the elimination of bio-
film in a model system using biofilm pro-
duced by Pseudomonas aeruginosa. Phy-
siological saline and Ringer solution were
completely ineffective in biofilm removal.
In contrast, Prontosan® eliminated the bio-
film with a ca 87% efficacy.
H-M Seipp et al., Zeitschrift für Wundheilung No. 4,
2005, p. 160-164.
Comparative study on the efficacy of
wound irrigation solutions in the removal
of biofilm produced by MRSA bacteria on
pig wounds. Tested solutions: Prontosan®
solution, physiological saline and Ringer
solution. MRSA bacteria were inoculated
on artificiall skin wounds and after 72
hours of growth and generation of a bio-
film by bacteria, the effectiveness of the
mentioned solutions was tested. Only Pron-
tosan® proved to be effective in eliminat-
ing the biofilm and MRSA from the wound
site. Both physiological saline and Ringer
solution did not demonstrate a measurable
effect on the wounds microbial load.
Prof. Steven Davies, University of Miami, USA, 2007,
unpublished data
.
7. Infection control and optimal effect of
therapeutics used
A retrospective analysis of the healing time
and healing performance of venous leg
ulcers in 112 patients treated with modern
wond dressings. Additionally, Prontosan®
solution was used for cleansing wounds
in a group of 59 patients and physiologi-
cal saline or Ringer solution were used in
the control group consisting of 53 patients.
In the period under observation secondary
infection was reported in 3% of patients
from the Prontosan® group and in 13% of
patients in the physiological saline/ Ringer
solution group.
A reduction of more than one month in the
average healing time was observed: from
4.42 month in the physiological saline/
Ringer solution group to 3.31 month in the
Prontosan® group. Wound healing perfor-
mance in the first 3 months was over twice
as high in the Prontosan® group than in the
physiological saline/ Ringer solution group:
60% of wounds healed in the Prontosan®
group against 28% of wounds healed in
the physiological saline group.
T. Eberlein et al. Die Schwester der Pfleger, 45, 9/2006,
p. 2-4.
Acceleration of wound healing
See above (T. Eberlein) and other experi-
ments:Wounds after amputation of frost-
bitten toes of both feet. An example illu-
strating the effect of Prontosan® solution
at all stages of the TIME framework: wo-
und cleansing, infection control, tissue mo-
isture balance and stimulation of healing
process.
Fig. 1 Wounds after ca 3 months after amputation
Fig. 2 The same wounds after 13 days of using Pron-
tosan solution
8. Prontosan® gel
Transparent, colourless, odourless, aqueous gel, free of regreasing compounds,
containing:
Component Description
0,1% undecylenimidopropyl surfactant ensuring cleansing effect
betaine
0,1% polyaminopropyl biguanide preservative with high tissue tolerance
(polyhexanide)
water for injection highly purified water, solvent
glycerol (glycerine) moisturising agent
hydroxyethylcellulose plant-derived gelling agent
Prontosan® solution
Transparent, colourless, odourless, aqueous solution containing:
Component Description
0,1% undecylenimidopropyl surfactant ensuring cleansing effect
betaine
0,1% polyaminopropyl biguanide preservative with high tissue tolerance
(polyhexanide)
water for injection highly purified water, solvent
Presentation Unit of Sale REF
Prontosan solution6 x
40 ml ampoule 1 400 414
Prontosan solution
350 ml bottle 1 400416
Presentation Unit of Sale REF
Prontosan gel
30 ml bottle 1 400 516
9. LAV-TIME
effective chronic wound treatment
LAVASEPSIS
wound bed preparation per se
TIME
TISSUE
MANAGEMENT
INFLAMMATION/
INFECTION CONTROL
MOISTURE
BALANCE
EPITHELIAL/EDGE/
ADVANCEMENT
optimal effect of therapeutic strategies applied
10. Przedstawiciel podmiotu odpowiedzialnego:
AESCULAP CHIFA Sp. z o.o.
ul. Tysi¹clecia 14,
64-300 Nowy Tomyœl,
tel. 061 44 20 100
fax 061 44 23 936
www.chifa.com.pl
Podmiot odpowiedzialny:
B.BRAUN Medical AG
Infection Control
Seesatz
CH-6203 Sempach-Station
info.bbmch@bbraun.com
www.bbraun.ch