An increased incidence of leukopenia has been reported in patients treated concurrently with cimetidine. Recovery is not influenced by continuation of silver sulfadiazine therapy. Rebound to normal leukocyte levels follows onset within 2 to 3 days. Maximal white blood cell depression occurs within 2 to 4 days of initiation of therapy. 1,2,3 Leukopenia associated with silver sulfadiazine administration is primarily characterized by decreased neutrophil count. Several cases of transient leukopenia have been reported in patients receiving silver sulfadiazine therapy. The use of SILVADENE Cream 1% (silver sulfadiazine) in some cases of glucose-6-phosphate dehydrogenase-deficient individuals may be hazardous, as hemolysis may occur. However, the incidence of clinically reported fungal superinfection is low. If allergic reactions attributable to treatment with silver sulfadiazine occur, continuation of therapy must be weighed against the potential hazards of the particular allergic reaction.įungal proliferation in and below the eschar may occur. There is potential cross-sensitivity between silver sulfadiazine and other sulfonamides. Some of the reactions, which have been associated with sulfonamides, are as follows: blood dyscrasias including agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, and hemolytic anemia dermatologic and allergic reactions, including life-threatening cutaneous reactions gastrointestinal reactions hepatitis and hepatocellular necrosis CNS reactions and toxic nephrosis. Although few have been reported, it is possible that any adverse reaction associated with sulfonamides may occur. Silver sulfadiazine is not a carbonic anhydrase inhibitor and may be useful in situations where such agents are contraindicated.Ībsorption of silver sulfadiazine varies depending upon the percent of body surface area and the extent of the tissue damage. To clarify non-inferiority, a larger study is needed.Results of In Vitro Testing with SILVADENE ® Cream 1% (silver sulfadiazine) Concentration of Silver Sulfadiazine Number of Sensitive Strains/Total Number of Strains Tested Genus & Species However, considering that silver nitrate cauterization carries a distinct risk of chemical burns and that the overall efficacy of topical steroid ointment treatment is similar to that of silver nitrate cauterization, topical steroid ointment might be considered as a good alternative in the treatment of neonatal umbilical granuloma due to its safety and simplicity. This study did not establish non-inferiority of topical steroid ointment treatment relative to silver nitrate cauterization, presumably due to lower healing rates than expected leading to an underpowered trial. No major complications occurred in either group. After 3 weeks of treatment, the healing rate with topical steroid ointment treatment was almost identical to that of silver nitrate cauterization (94/104 vs. The difference between groups was -5.5% (95% confidence interval, -19.1%, 8.4%), indicating that the non-inferiority criterion was not met. Healing rates after 2 weeks of treatment were 87.5% (91/104) in the silver nitrate cauterization and 82% (82/100) in the topical steroid ointment group group. Participants comprised 207 neonates with newly diagnosed umbilical granuloma, randomized to receive silver nitrate cauterization (n = 104) or topical steroid ointment (n = 103). The healing rate was evaluated until completion of 3 weeks of treatment. The primary endpoint for the silver nitrate cauterization and topical steroid ointment groups was the healing rate after 2 weeks of treatment, applying a non-inferiority margin of 10%. The aim of this prospective multicenter randomized controlled trial was to compare the efficacy of silver nitrate cauterization against that of topical steroid ointment in the treatment of neonatal umbilical granuloma.Īn open-label, non-inferiority randomized controlled trial was conducted from January 2013 to January 2016.
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