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Gazzetta Medica Italiana Archivio per le Scienze Mediche 2008 December;167(6):251-60


language: English

Efficacy and tolerability of “Fitostimoline® antibiotico” soaked gauzes in the topical treatment of cutaneous sores, ulcers and burns, complicated with bacterial contamination. An open-label, controlled, randomised, multicentre, parallel group

Romanelli M. 1, Dini V. 1, Bertone M. S. 1, Mazzatenta C. 2, Martini P. 2

1 Department of Dermatology University of Pisa, Pisa, Italy 2 Department of Dermatology University of Lucca, Lucca, Italy


Aim. “Fitostimoline® antibiotico” cream is a new formulation of Fitostimoline in which the antibiotic gentamycin has been added to the aqueous extract of Triticum vulgare.
Methods. A controlled, open-label, randomised, parallel group, prospective, multicentre phase III clinical trial design was planned and conducted with the aim to compare the activity and the safety of Fitostimoline® antibiotico gauzes with that of another preparation containing gentamicin present in italian market (Citrizan® antibiotico gel) in patients suffering from sores, ulcers and burns complicated with bacterial contamination. A total of 160 eligible outpatients of both gender (66% female) were randomly assigned to treatment with one of the two investigational study drugs and started the treatment in the day of the first visit. The drugs were applied b.i.d. and the control visits were scheduled weekly for 4 weeks. 139 patients completed the study. The main activity objective was to compare the changes of maximum transversal diameter of the lesions measured after 28 days of treatment (or otherwise at the end of the study), compared with the first day of treatment. Secondary objectives were to assess changes of the size of the surface of the lesion; changes over time of total symptoms’ score; changes over time of single signs and symptoms due to the lesion; percentages of healing; time (days) to healing (for the burns only); number and percentage of patients that required surgical or detersion procedures different from that used for conventional medications; use of rescue paracetamol; assessment of patients’ acceptance/agreement of therapy. Subjective and obiective symptoms were scored 0 to 3 (absent, mild, moderate, severe).
Results. The results over time of the primary efficacy variable (change of the maximum transversal diameter of the lesion) showed a progressive improvement from baseline to last visit in both groups.The mean adjusted percent change from baseline to the final visit was –29.2% in the gauzes group and –32.9% in the gel group, being the adjusted mean difference between groups 3.6% (95% CI: –5.2 to 12.5) (P = 0.42). The results of the measurement of the surface area were similar to tose obtained for the primary variable and showed a progressive improvement in the two groups from baseline to the end of treatment (P = NS between groups). Healing was observed in 10 patients (13.0%) in the gauzes group and in 11 (14.1%) in the gel group. Treatment with the two investigational study drugs was associated with a progressive improvement signs and symptoms and of the overall symptoms’ score; the analysis of individual signs and symptoms showed similar improvements in the two groups, with no statistically significant differences between groups in any of the measured parameters. The rate of patients that used rescue paracetamol was less than 30% in the the gauzes group and less than 20% in the gel group (P = NS). Most of patients in both treatment groups provided a very good or good opinion on treatment acceptability: the rate of patients that expressed a very good opinion was slightly higher in the gauzes group than in the gel group. Non serious adverse event were recorded 1 patient (1.3%) in the the gauzes group and in 5 (6.3%) in the gel group (P=0.21 between groups).
Conclusion. The overall results of the present study show that both drugs are safe and effective in the treatment of ulcers, sores and burns with bacterial contamination.

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