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A Journal on Physiopathology and Therapy of Chronic Cutaneous Ulcers


Official Journal of the Italian Association for Cutaneous Ulcers
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Acta Vulnologica 2009 March;7(1):31-8

Copyright © 2009 EDIZIONI MINERVA MEDICA

language: Italian

A new medical preparation for the treatment of skin lesions

Lualdi P. 1, Berzovini C. 2, Emanuelli G. 3, Fiori F. 4, Garibba R. 5, Germiglio C. 6, Ghezzi M. 7, Longobardi P. 8, Marletta S. 9, Mascaro A. 10, Mongiardino V. 11, Montanaro V. 12, Morisi C. 13, Mosca L. 14, Nicolardi M. M. 15, Panzone M. 16, Perrone C. 17, Pibiri L. 18, Regazzini R. 19, Rodano L. 20, Rusignolo F. 21, Sabatino V. 22, Serra C. 23, Stamerra V. 24, Torre C. 25

1 Erba, Como, Italia 2 Torino, Italia 3 Chirurgia Vascolare II, Monza, Milano, Italia 4 Nerviano, Milano, Italia 5 Presidio Ospedaliero L. Bonomo, Ambulatorio di Chirurgia Plastica, Andria, Bari, Italia 6 Azienda Ospedaliera Umberto I, Chirurgia Vascolare, Siracusa, Italia 7 Clinica S. Siro, Milano, Italia 8 Centro Iperbarico S.r.l., Ravenna, Italia 9 Ospedale Ferrarotto, Chirurgia Vascolare, Catania, Italia 10 Solignano di Castelvetro, Modena, Italia 11 Torino, Italia 12 Locorotondo, Bari, Italia 13 Ospedale Civile S. Maria delle Croci Ravenna, Italia 14 Grottaglie, Taranto, Italia 15 Spongano, Lecce, Italia 16 Vinovo, Torino, Italia 17 Ospedale “V. Fazzi”, Lecce, Italia 18 Azienda Ospedaliera Brutzu, Cagliari, Italia 19 Milano, Italia 20 Fondazione San Raffaele Cittadella della Carità Taranto, Italia 21 Azienda Ospedaliera Universitaria Policlinico P. Giaccone, Palermo, Italia 22 S. Paolo Belsito, Napoli, Italia 23 Ospedale S. Martino, Oristano, Italia 24 Azienda USL LE/2, Distr. n. 1 di Gallipoli Casa di Riposo e Protetta “S. Rita”, Alezio Lecce, Italia 25 ASL 6 Rep. Geriatria, Palermo, Italia


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Aim. To collect information on the efficacy and tolerability of Skincol® gel in the treatment vascular ulcers.
Methods. In this multicenter, non-controlled, observational phase IV study involving patients with venous stasis ulcers or other skin lesions, Skincol® gel was applied once daily for a maximum of 90 days. At control visits every 15 days, patients were assessed for: lesion extension; improvement in symptoms (inflammation, exudate, swelling, pain, burning); granulation tissue; healing time; judgement of product efficacy, tolerability and acceptability; ease of use and comparison with habitual therapies; type and severity of adverse events.
Results. Of 363 patients recruited, 353 (83.5% with vascular ulcers; 5.7% with diabetic ulcers; 8.5% with decubitus sores; 2.3% with burns or other skin wounds) received treatment with Skincol® gel. Of these 353 patients, final efficacy assessment was carried out on 344 patients. Lesion extension gradually decreased (global improvement P=0.0001; improvement at 15-day assessment over baseline P<0.05); granulation tissue formed (global improvement P=0.0006; improvement at 15-day assessment over baseline P<0.05); and symptoms improved (global improvement P=0.0019; improvement at 15-day assessment over baseline P<0.05); clinical healing was noted in 269 (78.2%) patients within 59.29±21.64 days. Clinical efficacy was judged as good to very good in 77% of cases; product acceptability and ease of use were judged as good to very good in 80.7% and 92.5% of cases, respectively; Skincol® gel was found to be better than habitual therapies in 67.9% of cases, equally good in 26.0%, and inferior in 6.0%. Product tolerability was judged good to very good in 83.7% of cases. During the study period, 11 (3.12%) adverse events occurred, 3 of which were local hypersensitivity reactions that led to suspension of treatment.
Conclusions. Within the limitations of an observational study such as this, the study product was found to be efficacious and well tolerated in the treatment of skin lesions of various origin.

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