https://doi.org/10.4081/ijwc.2022.92
Clinical evaluation of the efficacy and tolerability of a new device based on of Rigenase® and polyhexanide in the treatment of chronic skin lesions
Submitted: September 29, 2022
Accepted: November 21, 2022
Published: December 22, 2022
Accepted: November 21, 2022
Abstract Views: 441
PDF (Italiano): 207
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All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
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studio caso controllo di una medicazione composta da Rigenase© (stimolina di origina vegetale) addizionata di poliesanide, su un nuovo supporto in PET in triplo strato nel trattamento di lesioni cutanee croniche dell’arto inferiore. Scopo dello studio la valutazione in termini di riparazione e controllo del bioburden Batterico. Sono stati arruolati 20 pazienti con un periodo di run in di 6 settimane con terapia secondo i gold standard; a seguire un analogo periodo di trattamento con la medicazione in studio. I punti in esame sono stati l’evoluzione dell’area, misurata con un sistema basato su intelligenza artificiale come primario. End poin seocondari: livello di infezione/colonizzazione, WBP e dolore, tutti raccolti mediante scale validate. I dati raccolti inerentemente all’area hanno dimostrato una differenza statisticamente significativa (p<0.0001). differenze significative si sono evidenziate anche in termini di segni di infezione (p<0.001), WBP score (p<0.001) e dolore con NRS (p<0.0001). Non si sono riscontrati eventi avversi od effetti collaterali. Gli autori concludono che la medicazione dimostra una elevata capacità di stimolare la ripresa dei fenomeni riparativi in lesioni con scarsa tendenza spontanea alla riparazione.
Lazarus GS, Cooper DM, Knighton DR, et al. Definitions and guidelines for assessment of wounds and evaluation of healing. Arch Dermatol 1994;130:489-93.
DOI: https://doi.org/10.1001/archderm.130.4.489
Currie CJ, Morgan CL, Peters JR. The epidemiology and cost of inpatient care for peripheral vascular disease, infection, neuropathy, and ulceration in diabetes. Diabetes Care 1998;21:42-8.
DOI: https://doi.org/10.2337/diacare.21.1.42
Reiber GE. Diabetic foot care: financial implications and practical guidelines. Diabetes Care 1992;15:29-31.
DOI: https://doi.org/10.2337/diacare.15.1.S29
Rith-Najarian SJ, Stolusky T, Gohdes DM. Identifying diabetic patients at high risk for lower-extremity amputation in a primary health care setting. A prospective evaluation of simple screening criteria. Diabetes Care 1992;15:1386-9.
DOI: https://doi.org/10.2337/diacare.15.10.1386
Hunt D, Gerstein H. Piede diabetico. Clinical Evidence edizione italiana. Roma, 2002: pp. 284-9.
London NJM, Donnelly R. Ulcerated lower limb. BMJ 2000;320:1589-91.
DOI: https://doi.org/10.1136/bmj.320.7249.1589
The ICAI Study group. Prostanoids for chronic critical leg ischemia. A randomized controlled, open label trial with prostaglandin E1. Ann Int Med 1999;130:412-21.
DOI: https://doi.org/10.7326/0003-4819-130-5-199903020-00005
Di Giulio P. Mettere il dito sulla piaga. Occhio Clinico 1997;7:32-6.
O’Dea K. Prevalence of pressure damage in hospital patients in the UK. J Wound Care 1993;2:221-5.
DOI: https://doi.org/10.12968/jowc.1993.2.4.221
Sood A, Granick MS, Tomaselli NL. Wound Dressings and Comparative Effectiveness Data. Adv Wound Care (New Rochelle) 2014;3:511-29.
DOI: https://doi.org/10.1089/wound.2012.0401
Winter GD. Formation of the scab and the rate of epithelization of superficial wounds in the skin of the young domestic pig. Nature 1962;193:293-4.
DOI: https://doi.org/10.1038/193293a0
Ricci E. La filosofia delle medicazioni. Acta Vunologica 2006;4:3-7.
Falanga V. Classification for wound bed preparation and stimulation of chronic wounds. Wound Repair Regen 2000;8:347-52.
DOI: https://doi.org/10.1111/j.1524-475X.2000.00347.x
Harries RL, Bosanquet DC, Harding KG. Wound bed preparation: TIME for an update. Int Wound J 2016;13:8–14.
DOI: https://doi.org/10.1111/iwj.12662
Romanelli M, Miteva M, Romanelli P, et al. Use of diagnostics in wound management. Curr Op Support Palliative Care 2013;7:106-10.
DOI: https://doi.org/10.1097/SPC.0b013e32835dc0fc
Matthew P, Caley MP, Martins VLC, et al. Metalloproteinases and wound healing. Adv Wound Care 2015;4:225-34.
DOI: https://doi.org/10.1089/wound.2014.0581
Natural wound healing and bioactive natural products, Phytopharmacology 2013 REFERENZA INCOMPLETA
Antonucci I, Fiorentino G, Contursi P, et al. Antioxidant capacity of Rigenase® , a specific aqueous extract of Triticum vulgare. Antioxidants 2018;7:67.
DOI: https://doi.org/10.3390/antiox7050067
Tito A, Minale M, Riccio S, et al. Triticum vulgare extract exhibits regenerating activity during the wound healing process. Clin Cosmet Investig Dermatol 2020;13:21–30.
DOI: https://doi.org/10.2147/CCID.S216391
Fiore L, Scapagnini U, Riccio R, et al. Differential activities of Triticum vulgare extract and its fractions in mouse fibroblasts. Acta Ther 1993;19:151–162.
Morretta E, D’Agostino A, Cassese E, et al. Label-free quantitative proteomics to explore the action mechanism of the pharmaceutical-grade Triticum vulgare extract in speeding up keratinocyte healing. Molecules 2022;27:1108.
DOI: https://doi.org/10.3390/molecules27031108
Petrella F, Nebbioso G, Acquino M, et al. Studio osservazionale sull’utilizzo di un prodotto in garza contenente Rigenase® e poliesanide nel trattamento della cute perilesionale e delle ulcere venose (<6cm2). It J Wound Care 2022;6:89.
DOI: https://doi.org/10.4081/ijwc.2022.89
Zoppo G, Marrone F, Pittarello M, et al. AI technology for remote clinical assessment and monitoring. J Wound Care 2020;29:692-706
DOI: https://doi.org/10.12968/jowc.2020.29.12.692
Cutting KF, Harding KG. Criteria for identifying wound infection. J Wound Care 1994;3:198-201.
DOI: https://doi.org/10.12968/jowc.1994.3.4.198
Falanga V, Saap LJ, Ozonoff A. Wound bed score and its correlation with healing of chronic wounds. Dermatol Ther 2006;19:383-90.
Dawes RM. Suppose we measured height with rating scales instead of rulers. Appl Psychol Meas 1977;1:267-73.
DOI: https://doi.org/10.1177/014662167700100213
AA Vari. Principless of best practice: wound infection in clinical practice. An international consensus. London: MEP Ltd, 2008
Schultz G, Sibbald G, Falanga V, et al. Wound bed preparation: a systematic approach to wound management. Wound Rep Reg 2003;11:1-28.
DOI: https://doi.org/10.1046/j.1524-475X.11.s2.1.x
Falanga V, Saap LJ, Ozonoff A. Wound bed score and its correlation with healing of chronic wounds. Dermatol Ther 2006;19:383-90.
DOI: https://doi.org/10.1111/j.1529-8019.2006.00096.x
Downie WW, Leatham PA, Rhind VM et al. Annals of the Rheumatic Diseases, 1978, 37, 378-381 Studies with pain rating scales.
DOI: https://doi.org/10.1136/ard.37.4.378
How to Cite
Ricci, E., & Pittarello, M. (2022). Clinical evaluation of the efficacy and tolerability of a new device based on of Rigenase® and polyhexanide in the treatment of chronic skin lesions. Italian Journal of Wound Care, 6(2). https://doi.org/10.4081/ijwc.2022.92
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