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Official Journal of the Italian Society of Dermatology and Sexually Transmitted Diseases
Indexed/Abstracted in: EMBASE, PubMed/MEDLINE, Science Citation Index Expanded (SciSearch), Scopus
Impact Factor 1,014
Online ISSN 1827-1820
Neri R., Melandri D., Pierleoni M., Polverelli M., Brunelli D., Morri M., Saponati G. *, Landi G.
Azienda U.S.L. Cesena - Ospedale «M. Bufalini» U.O. Dermatologia e Centro Grandi Ustionati
*ISPharm s.r.l. - Lucca
Background. The well-known medicinal speciality Fitostimoline gauze® contains properties that stimulate tissue repair processes. This study was carried out to confirm these properties in a large group of burn patients.
Methods. The double-blind, randomized, controlled vs placebo clinical trial using halfparts was approved by the Ethical Committee. A total of 50 burns patients were studied (2nd degree burns) with a mean age of 36 years, presenting a total of 100 burnt skin areas half of which were treated with Fitostimoline gauze and half with placebo gauze. Treatment was continued for three weeks, or shortened proportionally in the event of a rapid recovery. Controls were made on day 7, 14 and at the end of the study. Together with the healing time (day on which complete re-epithelialisation occurred), the dimensions of the lesion (transverse diameter in mm) were evaluated as the primary end-point of the study, and these were then used to calculate the area of the lesion.
Results. Lesions treated with the pharmacological inactive preparation showed a gradual improvement of clinical conditions, following a linear trend and with re-epithelialisation of 48 out of 50 lesions at the end of the study. The mean area of the burns treated with Fitostimoline (17863 mm2) was much larger on admission than that of control burns (8801 mm2) ; during the course of the first week the clinical situation evolved in parallel, whereas during the course of the second week the repair processes accelerated significantly. By day 14 the extent of the re-epithelialised surface was relatively similar in both groups and by the end of the study 47 out of 50 areas treated with Fitostimoline had healed. No adverse local or systemic effects were reported during the study.
Conclusions. This experience of using Fitostimoline in a highly specialised sector like burns indicates that the pharmaceutical formula of Fitostimoline gauze can provide the essential protection for regenerating tissue and that the active component can also stimulate the evolution of the repair process.