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

OBJECTIVES

Compare the efficacy and tolerability of Connettivina Bio Plus (Group A) gauze and cream, and Fitostimoline 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, = 30; Group B, = 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 Bio Plus and 28 patients undergoing treatment with Fitostimoline Plus. The greater effectiveness of the latter was significant ( = 0.00104). In Group B, a significantly greater degree of effectiveness was observed in reducing the fibrin in the wound bed ( = 0.04746). Complications or unexpected events were not observed.

CONCLUSIONS

Both Connettivina Bio Plus and Fitostimoline Plus are secure and effective for treating acute superficial skin lesions. Fitostimoline Plus was more effective than Connettivina Bio Plus in wound healing of acute superficial skin lesions, especially if fibrin had been observed in the wound bed.