The Effectiveness and Safety of 1% Silver Sulfadiazine (Flammazine)Cream in Preventing Infection in Potentially Contaminated TraumaticWounds among Pediatric Patients 2 To <18 Years Old: An Open-Label,Single-Arm Phase 3 Clinical Trial

Abstract

This is an open label, descriptive, single-arm study of patients, 2 to <18 years of age conducted at the out-patient department, Research Institute for Tropical Medicine (RITM), the primary objective of which is to evaluate the effectiveness and safety of silver sulfadiazine in preventing infection in potentially contaminated traumatic wounds among children 2 to <18 years of age. All of the 50 subjects enrolled had contaminated wound upon enrolment, without oral antibiotics and other topical medications previously used. After seven days of Flammazine application, 100% had clinical successand after 14 days of application, 100% of the subjects likewise had persistent clinical success. At baseline, the most common criteria present was pain (96%) followed by erythema (94%). 58% had mild itching, and 56% had mild tissue edema. Overall, the SIRS (Severity of Infection Rating Scale) scores improved after 7 days (100%) and 100% of the subjects had SIRS score of 0 after 14 days. The study has shown that 1% Silver Sulfadiazine appears to be an effective and safe alternative to antibiotics in the management of wound infections which are potentially contaminated among children 2 to <18 years of age.