METHOD: We performed a multi centerrandomized controlled trial involving three regional pediatricsurgical units. We included children who presented with umbilical granuloma from December 2018 to May 2020. Children who received treatment prior to index visit were excluded. They were randomly allocated to receive NaCl (twice/day application for 5 days by caregiver) or CuSO4 (single application by clinician). Demographic data, compliance in the NaCl group by pill counting method, treatment outcomes, and complications were recorded. Treatment success was defined as complete lesion resolution. Partial or no response was considered treatment failure. Subsequent treatment then reverted to the respective center's routine management.
RESULT: We recruited 70 participants with 6 dropouts (2 defaulters, 1 vitellointestinal duct, 3 urachal remnants), leaving 64 subjects for final analysis: 31 NaCl, 33 CuSO4. Compliance rate of 77.4% was recorded for NaCl, with 6 (20%) 'poor compliance' participants stopping therapy before completion owing to complete resolution. NaCl group had a significantly higher complete resolution rate (90.4%) compared to CuSO4 (69.7%), p = 0.040. No NaCl participant developed complications versus 9% (n = 3) in CuSO4 (periumbilical superficial skin burn).
CONCLUSION: Table salt is an ideal treatment choice for umbilical granuloma as it is effective, safe, and readily available.
LEVEL OF EVIDENCE: II.