ABSTRACT
Aim:
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). Materials and
Methods:
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.
Results:
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.
Conclusion:
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.