TIMING AND REGENERATION FOR WOUND CARE
UNIQUE FORMULATION FOR PROMOTION OF HEALING AND SELECTIVE WOUND BED PREPARATION
Class III
Medical Device
Î very fluid, smooth and simple to apply (1)
Î no discomfort nor pain for the patient (8)
STORAGE Store a temperature not exceeding 30 °C. Do not freeze.
Hyaluronic Acid Sodium Salt 0.2%
Collagenase from Vibrio alginolyticus Ointment | 30 g Tube for topical use
Product description Format Articles per pack
Hyalo4 Start 30 g tube 1
REFERENCES:
1. FIDIA, data on file; 2. Chen WY, Abatangelo G. Functions of hyaluronan in wound repair. Wound Repair Regen 1999;7(2):79-89; 3. David-Raoudi M, et al. Differential effects of hyaluronan and its fragments on fibroblasts: relation to wound healing. Wound Repair Regen 2008;16:274-87;
4. Soma P.F., Stella M., Comitini S. The role of hyaluronic acid medication on re-epithelialization: clinical model In: Atti del 37 Congresso Nazionale della Società Italiana di Chirurgia Plastica Ricostruttiva ed Estetica, Monduzzi Editore 1988; 115-122; 5. Torregrossa F, Caroti A. Clinical verification of the use of topical hyaluronic acid under non-adhesive gauze in the therapy of torpid ulcers. G Ital Dermatol Venereol. 1983 Jul-Aug;118(4):XLI- XLIV. Italian. 6. Passarini G., Tosti A., Fanti P.A., Varotti C. Effect of hyaluronic acid on the healing of stasis ulcers-controlled study Giornale Italiano di Dermatologia e Venerologia 1982; 117(3), 27-30; 7. Di Pasquale R, Vaccaro S, Caputo M, et al. Collagenase-assisted wound bed preparation:
An in vitro comparison between Vibrio alginolyticus and Clostridium histolyticum collagenases on substrate specificity. Int Wound J. 2019;1–11;
8. Onesti MG, Fioramonti P, Fino P, Sorvillo V, Carella S, Scuderi N. Effect of enzymatic debridement with two different collagenases versus mechanical debridement on chronic hard-to-heal wounds. Int Wound J. 2016;13(6):1111-5; 9. Scalise A, Campitiello F, Della Corte A, et al.
Enzymatic debridement: is HA-collagenase the right synergy? Randomized double-blind controlled clinical trial in venous leg ulcers. Eur Rev Med Pharmacol Sci. 2017;21(6):1421-31.
www.fidiawoundcare.com
Promote healing while prepares the wound bed (1)
Î Allows the preparation of the wound bed, thanks to the hydrating properties of Hyaluronic Acid that promotes the natural repair process and protects the new viable tissue
(9)Î More rapid wound bed cleansing and healing clinically-demonstrated versus a Clostridium histolyticum-based product
(8)Î The absence of non-specific protease entails a totally specific action with no bothersome dermatitis around the wound
(7)Î Reduced pain referred by patients versus a Clostridium histolyticum- based product
(8)COD. 99002029
Ease of use:
Advantages
Local management of chronic ulcers (i.e. pressure sores, vascular ulcers of the legs, diabetic ulcers). In particular, it is intended to provide an optimal moist environment and wound bed preparation that supports the natural healing process.
Indication
Composition
Pressure Sores Vascular Ulcers of Legs Diabetic Ulcers
OH HO
D – GLUCURONIC ACID N - ACETYL GLUCOSAMINE
HO
NH OH OH O
O O
O
O
O n
HYALURONIC ACID (HA) - PRINCIPAL COMPONENT (200kDa molecular weight)
Î Creates a moist enviroment for optimal tissue repair
(1,2)Î Generates microenvironment supporting the secretion of growth factors, proliferation and migration of fibroblasts, endothelial cells, keratinocytes and angiogenesis
(2,3)Î Decreases healing time consequently causing a reduction in nursing time and expenses
(4,5,6)COLLAGENASE FROM VIBRIO ALGINOLYTICUS STRAIN
Î Highly purified enzyme, degrades fibrinous and necrotic tissue contributing to wound bed preparation
(7)Î The collagenase in Hyalo4 Start is 99% pure.
The absence of non-specific protease entails a totally specific action with no bothersome dermatitis around the wound
(7)Î Selective removal of necrotic tissue, does not degrade other minor, but structurally important, components of the dermal ECM
(7)Comparison of 3 wound bed preparation techniques on chronic wounds
Patients
HA + V. alginolyticus
(B Group) C. histolyticum
(N Group) wet-to-dry gauze (M Group)
30 30 30
AT 4 WEEKS AT 8 WEEKS
GROUPS COMPLETE WOUND BED CLEANSING
HA+V. ALGINOLYTICUS (B) 66,6% (20 pts) 96,6% (29 pts)
C. HISTOLYTICUM (N) 56,6% (17 pts) 96,6% (29 pts)
WET-TO-DRY GAUZE (M) 30% (9 pts) 63,3% (19 pts)
AT 8 WEEKS GROUPS COMPLETE WOUND
HEALING (% PATIENTS) WOUND AREA
REDUCTION (MEAN %*) VAS PAIN SCORE
REDUCTION (MEAN %) INTEGRATED WOUND MARGINS (%)
HA+V. ALGINOLYTICUS (B) 33% 84% 65%* 80%
C. HISTOLYTICUM (N) 27% 77% 44% 73%
WET-TO-DRY GAUZE (M) 20% 52% 31% 54%
*=p<0,0093
Onesti MG, Fioramonti P, Fino P, Sorvillo V, Carella S, Scuderi N. Effect of enzymatic debridement with two different collagenases versus mechanical debridement on chronic hard-to-heal wounds. Int Wound J 2015; doi: 10.1111/iwj.12421
Unique and powerful formulation for rapid wound healing supported by selective removal
of necrotic and non viable tissue
Best area reduction
(8)Best pain reduction
(8)Protects peri-wound skin
(8)Wound bed cleansing
(8)(8)
TO T4 T8
C. histolyticum collagenase (N group)
V. alginolyticus
collagenase
(B group)
