Double Ligation and Topical Silver Nitrate

Shaheed Zulfiqar Ali Bhutto Medical University176 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

176

Conditions

Umbilical Granuloma

Interventions

Double LigationPROCEDURE

Topical Silver NitrateDRUG

Eligibility

Sex: ALLMax age: 12 Months

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Frequency of Success/Failure of treatment

The 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.

Time frame: 3 weeks

Frequency of complications in both groups

The 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

Time frame: 3 weeks

Data from ClinicalTrials.gov

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