Aims: This multicenter, multinational, randomized, double-blind, controlled, parallel-group study, was designed to assess the efficacy and safety of a fixed combination topical medicinal product, containing 0.2% hyaluronic acid and 1% silver sulfadiazine (HA-SSD) (Connettivina Plus cream) versus 1% silver sulfadiazine cream alone (SSD), in the treatment of second-degree burns.
Methods: 111 adult patients (age 18-75 years) of both sexes, with IIa-degree (superficial) and IIb-degree (deep dermal) burns, were randomized to receive HA-SSD or SSD. Treatments (approximately 5 g/100 cm2) were applied once a day until the wounds healed, but for no longer than 4 weeks. Burns had to have occurred within 48 hours from the start of treatment, be caused by thermal injury, and be confined to the trunk and/or upper and lower extremities.
Results: Results showed that both the fixed combination HA-SSD, and SSD alone, were effective and well tolerated topical agents for the treatment of second-degree burns. All burns were healed except in one patient treated with SSD. It was also observed that the fixed combination HA-SSD caused a significantly more rapid re-epithelialization of burns, i.e. a shorter time to healing, than SSD alone. The difference recorded--4.5 days--was statistically significant (p = 0.0073).
Conclusion: The observed shorter time to healing caused by the fixed combination is clinically relevant and further demonstrates the wound healing activity of HA.