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Indexed/Abstracted in: BIOSIS Previews, EMBASE, Scopus, Emerging Sources Citation Index
Online ISSN 1827-1812
Cattedra di Gerontologia Azienda Ospedaliera “Canizzaro”, Catania, Italia
Aim. This multicenter randomized controlled trial was conducted on outpatients of both sexes with deepithelialized skin lesions or infected dystrophic ulcers in order to determine the therapeutic efficacy and safety of a new formulation of fitostimoline cream containing gentamycin (Fitostimoline® antibiotico).
Methods. The study population (n=124) was randomly assigned to 2 treatment groups: the one (n=63) applied fitostimoline antibiotic cream, the other (n=61) applied gentamycin cream twice daily for 15 days. Assessment was performed at the start of the study (baseline), at 7 days into the study, and then at the end of the study. At each assessment, the site, characteristics and size of the wound, and clinical symptoms (pain, burning, itching, swelling, edema, exudation, and erythema) were scored on a numerical scale. At the control visits, the clinical progression of the wound (healed, significantly improved, improved, unchanged, worse) was recorded and any side effects were noted.
Results. In both groups a decrease was noted in the mean size of the wound, which was larger in the fitostimoline antibiotic-treated group at baseline, but the decrease was greater in this group. By the end of the study period, 17.5% of patients in the fitostimoline-treated group had progressed to complete healing, the wound had improved significantly in 27%, improved in 47.6%, and remained unchanged in 7.9% versus 8.2%, 11.5%, 65.6%, and 14.7%, respectively, in the gentamycin-treated group (P<0.05 between groups). Clinical symptoms gradually remitted during the course of the study and resolved nearly completely at completion. No side effects occurred and no subjects withdrew from the study, unless because of early wound healing.
Conclusion. Fitostimoline® antibiotic cream has an antimicrobial profile efficacy comparable to that of gentamycin and maintains its tissue regenerating and healing effect. Its elevated tolerability is similar to that of Fitostimoline® cream.