RESUMEN
BACKGROUND: It is current practice for physicians to use the Prontosan® range of products in children based on their personal clinical experience, despite the lack of safety data in this population. This retrospective data review was designed to obtain information on the safety profile of the Prontosan® range of products in children in routine clinical practice. METHODS: Data from newborns, infants and children with burns treated with the Prontosan® range were collected retrospectively from patient medical records. RESULTS: The majority of children treated for burns (80.1%) were under the age of four. More boys than girls were subject to burn injury (58.1% vs. 41.9%). The majority of burns (74.7%) were partial thickness burn (IIa and IIb). Safety was analysed based on the adverse events/reactions, infections and interactions/symptoms related to Prontosan® reported in the CRFs. AEs were reported in five children after the use of Prontosan® products: itching (3 cases), rash (1 case) and hypergranulating tissue (1 case). No event was severe and all events resolved favourably with good healing results. In addition, 11 patients developed clinical signs of infection during treatment (mainly Staphylococcus aureus). CONCLUSIONS: The Prontosan® range of products is demonstrated as safe and tolerable for use in children as part of burn treatment. Inclusion of this range of products in the protocol of paediatric burn care allows a good healing process starting with appropriate wound cleansing and maintaining moist wound environment.