Clinical Evaluation of the Efficacy and Tolerability of Rigenase (R) and Polyhexanide (Fitostimoline (R) Plus) vs. Hyaluronic Acid and Silver Sulfadiazine (Connettivina (R) Bio Plus) for the Treatment of Acute Skin Wounds: A Randomized Trial

Objectives: Compare the efficacy and tolerability of Connettivina (R) Bio Plus (Group A) gauze and cream, and Fitostimoline (R) Plus (Group B) gauze and cream for the treatment of acute superficial skin lesions. Design: Single-center, parallel, randomized trial. A block randomization method was used. Setting: University of Salerno-AOU San Giovanni di Dio e Ruggi d'Aragona. Participants: Sixty patients were enrolled. All patients fulfilled the study requirements. Intervention: One application of the study drugs every 24 h, and a six-week observation period. Main outcome measures: Efficacy and tolerability of the study drugs. Results: In total, 60 patients (Group A, n = 30; Group B, n = 30) were randomized; mean age was 58.5 +/- 15.8 years. All patients were included in the outcome analysis. Total wound healing was achieved in 17 patients undergoing treatment with Connettivina (R) Bio Plus and 28 patients undergoing treatment with Fitostimoline (R) Plus. The greater effectiveness of the latter was significant (p = 0.00104). In Group B, a significantly greater degree of effectiveness was observed in reducing the fibrin in the wound bed (p = 0.04746). Complications or unexpected events were not observed. Conclusions: Both Connettivina (R) Bio Plus and Fitostimoline (R) Plus are secure and effective for treating acute superficial skin lesions. Fitostimoline (R) Plus was more effective than Connettivina (R) Bio Plus in wound healing of acute superficial skin lesions, especially if fibrin had been observed in the wound bed.