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Double Ligation and Topical Silver Nitrate

Comparison of Double Ligation and Topical Silver Nitrate for Treatment of Umbilical Granuloma in Children: A Randomized Control Trial

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04248101
Acronym
RCT
Enrollment
176
Registered
2020-01-30
Start date
2016-07-01
Completion date
2017-07-01
Last updated
2020-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Umbilical Granuloma

Keywords

Double Ligation, Topical Silver Nitrate

Brief summary

To study and compare the efficacy and safety of Double Ligation and Topical Silver Nitrate Solution while treating children with Umbilical Granulomas

Detailed description

The patients underwent one treatment option and then followed up for three weeks and the results noted in terms of success/failure and complications specific to each treatment option and analysed accordingly

Interventions

PROCEDUREDouble Ligation
DRUGTopical Silver Nitrate

Sponsors

Shaheed Zulfiqar Ali Bhutto Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 12 Months
Healthy volunteers
No

Inclusion criteria

1\. Patients of Umbilical Granuloma, less than 1 year age

Exclusion criteria

1. Patients who already had any treatment 2. Parents refused to give consent for enrollment 3. Patients lost in follow up

Design outcomes

Primary

MeasureTime frameDescription
Frequency of Success/Failure of treatment3 weeksThe effect of treatment was noted in a structured proforma on weekly basis for 3 weeks. Treatment was considered successful if, on local examination the granuloma disappeared completely and did not reappear during the follow up period. And if the granuloma did not disppear completely during the follow up period after double ligation or application of silver nitrate, treatment was considered to have failed. These variables were measured as frequency and percentages. The results were compared between the two groups using chi-square test. A significance level of \<0.05 was considered significant.
Frequency of complications in both groups3 weeksThe complications were also noted in the above mentioned proforma during the follow up period on weekly basis for 3 weeks. Complications relevant to the treatment i.e. infection, bleeding, chemical burns and skin discoloration were noted during local examination. These variables were measured as frequency and percentages. The results were compared between the two groups using chi-square test. A significance level of \<0.05 was considered significant

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026