Common Salt versus Silver Nitrate for the Treatment of Umbilical Granuloma in Infants: An Open-label, Single-center, Pilot Randomized Controlled Trial.

Abstract

This study aims to compare the efficacy and safety of topical application of common salt (CS) in comparison to silver nitrate (SN) for treating infants with umbilical granuloma (UG). We conducted an open-label, prospective, single-center, pilot randomized controlled trial. Thirty-seven infants with a clinical UG diagnosis were enrolled between October 2022 and July 2023, excluding those previously treated for UG. Patients were randomly assigned (using the Randomizer® app) to receive either topical CS (applied thrice daily by caregivers at home for 5 days) or SN (applied by pediatric surgeon in clinic and kept under occlusive dressing for 48 h). Patients with partial/no healing received an additional session of the same treatment. Nonresponders transitioned from CS to SN, and vice versa, for two more applications. Healing rates were compared with a significance level of α =0.05. Out of 34 patients (18 CS and 16 SN), 32 successfully completed the trial (17 CS and 15 SN). No significant differences were observed in baseline characteristics. Efficacy rates of CS (19/22; 86.36%) and SN (11/17; 64.71%) did not significantly differ (P = 0.056; 95% confidence interval [CI] -0.4832-0.0502). No major adverse events were reported. CS showed superior healing outcomes in infants below 3 months of age (19/22; 86.36%) compared to SN (11/17; 64.71%) (P = 0.056; 95% CI - 0.4832-0.0502). The timing of umbilical cord detachment did not significantly affect healing rates. Widespread availability, ease of access, suitability for safe home application, and cost-effectiveness make CS a primary treatment option for UG. Larger patient cohorts are needed for conclusive results.