silver sulfadiazine
Regulatory sources consulted
Approved indications
- Treatment and prevention of infection in second- and third-degree burns and in venous or pressure ulcers.
Contraindications
Absolute
- Hypersensitivity to silver sulfadiazine, other sulfonamides, or excipients.
- Premature and newborn infants; term pregnancy and breastfeeding when lesions permit extensive absorption, because of kernicterus risk.
Clinical warnings
- Major warning · It may cause leukopenia; monitor blood counts during extensive or prolonged treatment. G6PD deficiency carries a risk of hemolysis. — CIMA/AEMPS, ficha técnica 49750
- Major warning · Stop immediately if signs of Stevens–Johnson syndrome or toxic epidermal necrolysis occur and do not re-expose. — CIMA/AEMPS, ficha técnica 49750
- Do not expose treated areas to direct sunlight: photosensitivity with local skin discoloration and grey discoloration of the cream may occur. — CIMA/AEMPS, ficha técnica 49750
- Eczema, allergic dermatitis, and skin discoloration due to photosensitization have been reported with unknown frequency. — CIMA/AEMPS, ficha técnica 49750
- Major warning · Percutaneous absorption, particularly from open wounds, may cause systemic sulfonamide effects—hematologic, renal, intestinal, and cutaneous—with greater risk in renal or hepatic impairment. — CIMA/AEMPS, ficha técnica 49750
- Major warning · Applying large amounts to very extensive wounds may increase serum osmolality because of propylene glycol absorption. — CIMA/AEMPS, ficha técnica 49750
Adverse events
Common (≥1%)
Leukopenia
Rare but serious
Stevens–Johnson syndrome or toxic epidermal necrolysis · Hemolysis in G6PD deficiency
Pregnancy and lactation
Avoid at term and during breastfeeding when lesions permit extensive absorption. At other stages, use only after assessing benefit and risk.
Recent literature (PubMed)
Giant omphalocele management had not reached a consensus from the pediatric surgical perspective regarding conservative treatments, surgical approaches, and clinical outcomes. This topic was therefore selected for the 2023 Consensus Session of the European Paediatric Surgeons' Association (EUPSA).Literature review was conducted by seven EUPSA members, guided by a set of predefined areas relating to the management of giant omphalocele: (1) conservative management, (2) surgical management, and (3) outcomes. Members were assigned to specific topics, with discrepancies resolved through structured group discussion and further literature review. Consensus was reached through unanimous agreement among the contributing members. Each topic was presented with available evidence to congress participants. Comments from participants were accounted to formulate the final consensus statement.Giant omphalocele is appropriately defined as viscero-abdominal disproportion preventing primary closure. Regarding (1) conservative management, the "paint and wait" approach is recommended when anatomical constraints or high surgical risk preclude primary closure. Common painting agents include povidone-iodine and silver sulfadiazine, with Manuka honey gaining interest, though consensus on dosing, duration, and complications remains unclear. With regards to (2) surgical management, early closure favors biological meshes, while delayed closure appears most effective using native tissues. High mortality in delayed patch closure likely reflects a population with the most severe defects. Finally, (3) outcomes highlights key prognostic factors including chromosomal abnormalities, cardiac defects, and low birth weight, which may guide counseling, screening, and treatment. Limited data on ruptured omphalocele indicates towards increased mortality, necessitating prompt intervention. Complications following management are relatively rare and typically intervention-related, underscoring the need for lo
Peceleganan spray is a novel topical antimicrobial agent targeted for the treatment of skin wound infections. However, its efficacy and safety remain unclear. To assess the safety and efficacy of peceleganan spray for the treatment of wound infections. This multicenter, open-label, phase 3 randomized clinical trial recruited and followed up 570 adult patients diagnosed with secondary open wound infections from 37 hospitals in China from August 23, 2021, to July 16, 2022. Patients were randomized to 2 groups with a 2:1 allocation. One group received treatment with 2% peceleganan spray (n = 381) and the other with 1% silver sulfadiazine (SSD) cream (n = 189). The primary efficacy outcome was the clinical efficacy rate (the number of patients fulfilling the criteria for efficacy of the number of patients receiving the treatment) on the first day following the end of treatment (day 8). The secondary outcomes included the clinical efficacy rate on day 5 and the bacterial clearance rate (cases achieving negative bacteria cultures after treatment of all cases with positive bacteria cultures before treatment) on days 5 and 8. The safety outcomes included patients' vital signs, physical examination results, electrocardiographic findings, blood test results, and adverse reactions. Among the 570 patients randomized to 1 of the 2 groups, 375 (98.4%) in the 2% peceleganan treatment group and 183 (96.8%) in the 1% SSD control group completed the trial (n = 558). Of these, 361 (64.7%) were men, and the mean (SD) age was 48.6 (15.3) years. The demographic characteristics were similar between groups. On day 8, clinical efficacy was achieved by 339 patients (90.4%) in the treatment group and 144 (78.7%) in the control group (P < .001). On day 5, clinical efficacy was achieved by 222 patients (59.2%) in the treatment group and 90 (49.2%) in the control group (P = .03). On day 8, bacterial clearance was achieved by 80 of 334 patients (24.0%) in the treatment group and in 75 of 163 (46.
Silver sulfadiazine, a topical antimicrobial that releases silver ions to disrupt bacterial cell membranes, is primarily used for second- and third-degree burns owing to its broad-spectrum activity against bacteria, fungi, and certain viruses. Beyond burns, silver sulfadiazine can be used off-label for conditions such as diabetic and pressure ulcers, atopic dermatitis, and radiation dermatitis. The literature suggests it may reduce bacterial load, accelerate healing, and address challenges such as multidrug-resistant Staphylococcus aureus. Rare side effects, including localized reactions and systemic toxicity with extensive use, necessitate cautious application, especially in vulnerable populations. Despite these limitations, silver sulfadiazine remains a cornerstone of dermatological wound care. Continued research is needed to optimize its use alongside emerging therapies.
The insertion of topical antimicrobials in wound treatment represented an important role in patient management. Among these agents, silver sulfadiazine (AgSD), introduced in the therapy of wounds and burns in the 1960s, is considered the gold standard in treatment due to its mechanism of action, in addition to its proven efficacy and safety. The association of AgSD with polymers for the development of curative formulations has been reported. The evaluation of the physical-chemical properties of these systems with the aid of analytical techniques of characterization is essential for the determination of their activities, besides allowing the detection of possible incompatibilities between AgSD and polymers. Thus, this review presents the main techniques of physicochemical characterization used in the evaluation of systems containing AgSD with curative purposes in order to provide parameters to ensure the efficacy and safety of these new therapeutic options. Microscopic, thermoanalytical, and spectroscopic techniques, for example, provide information on system properties such as surface chemical composition, crystallinity, morphology, and thermal stability of curative formulations containing AgSD. These techniques are important in the selection of the most appropriate techniques during the development of a polymeric curative system containing AgSD, in addition to providing information for cost reduction of a possible scale-up and the establishment of methodologies for quality control of these systems to ensure their efficacy and safety.
Cerium and its derivatives have been used as remedies for wounds since the early 20th century. Cerium nitrate has attracted most attention in the treatment of deep burns, followed later by reports of its antimicrobial properties. Its ability to mimic and replace calcium is presumed to be a major mechanism of its beneficial action. However, despite some encouraging results, the overall data are somewhat confusing with seemingly the same compounds yielding opposing results. Despite this, cerium nitrate is currently used in wound treatment in combination with silver sulfadiazine as Flammacérium. Cerium oxide, especially in nanoparticle form (Nanoceria), has lately captured much interest due to its antibacterial properties mediated via oxidative stress, leading to an increase of published reports. The properties of Nanoceria depend on the synthesis method, their shape and size. Recently, the green synthesis route has gained a lot of interest as an alternative environmentally friendly method, resulting in production of effective antimicrobial and antifungal nanoparticles. Unfortunately, as is the case with antibiotics, emerging bacterial resistance against cerium-derived nanoparticles is a growing concern, especially in the case of bacterial biofilm. However, diverse strategies resulting from better understanding of the biology of cerium are promising. The aim of this paper is to present the progress to date in the use of cerium compounds as antimicrobials in clinical applications (in particular wound healing) and to provide an overview of the mechanisms of action of cerium at both the cellular and molecular level.