FLAMMAZINE (sulfadiazine argentique)

Key points

Favourable opinion for reimbursement in the prevention and treatment of infections in the context of the management of second-degree or more severe burns in adults and children from 2 months of age.

What therapeutic improvement?

No clinical added value in the therapeutic strategy.

Role in the care pathway?

In the initial phase of topical treatment of deep burns, the aim is to cover the burned areas in order to limit pain, hypothermia and the risk of microbial contamination pending a specialist’s opinion.

Dressings must be applied in an appropriate environment in terms of hygiene, and will generally require strong analgesia or even a general anaesthetic. Burns should be mechanically cleaned using tap water, normal saline solution or an antiseptic prior to dressing application.

The choice of dressing type primarily depends on the surface area of the burn and its local appearance, as well as the patient’s general condition and local availabilities. The routine use of creams or ointments before application of the interface is optional. Little clinical evidence is available enabling the superiority of any specific dressing to be established. An antiseptic dressing may be appropriate in the event of extensive or contaminated burns.

Topical or systemic antibiotics should be reserved for cases of confirmed infection. Systemic prophylactic antibiotic therapy may only be considered in the perioperative period since it leads to a risk of multi-resistant bacteria selection.

Silver sulfadiazine and silver dressings may be used during the initial treatment phase. They are preferred to povidone-iodine due to the painful nature of the latter product. Compresses and creams containing silver sulfadiazine and hyaluronic acid with the status of medical devices are not currently funded by the national health insurance system.

In practice, management may be variable from one centre to another, although practices are tending to become harmonised based on available clinical evidence. There are two approaches: the first is the macerative approach, allowing a certain amount of bacterial growth, which contributes to wound debridement, and the second, used in paediatric patients, leaves the wound uncovered after cleaning, promoting drying out and asepsis. Tulle gras dressings must not be used in paediatric patients.

Role of the medicinal product in the care pathway:

Considering:

• not very robust data supporting the efficacy of silver sulfadiazine in the prevention and treatment of infections in the context of the management of second-degree or more severe burns in adults and children from 2 months of age,
• a risk of serious cutaneous, haematological and renal adverse effects, particularly in young children,

but considering:

• the exceptional nature of the serious adverse effects in view of the cumulative exposure,
• a partially met medical need, particularly in the event of extensive burns or burns affecting areas of the body where antiseptic dressings are not appropriate (face, hands),
• the benefit of having access to silver sulfadiazine in cream form, which is comfortable for patients when applied (analgesic and refreshing effect, less painful dressing changes than with antiseptic-impregnated dressings), although this benefit still remains to be demonstrated,

the Transparency Committee considers that the proprietary medicinal product FLAMMAZINE cream (silver sulfadiazine) is a first-line treatment in the therapeutic strategy for the prevention and treatment of infections in the context of the management of second-degree or more severe burns in adults and children from 2 months of age.

The Committee reiterates that burns managed in the community medicine setting that have not healed after 2 weeks of treatment require the medical opinion of a hospital department specialising in the management of burns, in accordance with the SPC for FLAMMAZINE (silver sulfadiazine).