Double Ligation and Topical Silver Nitrate

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

Detailed Description
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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

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

Conditions
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Umbilical Granuloma

Intervention / Treatment
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* Procedure: Double Ligation
* Drug: Topical Silver Nitrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Patients of Umbilical Granuloma, less than 1 year age Exclusion Criteria: Patients who already had any treatment Parents refused to give consent for enrollment Patients lost in follow up

Ages Eligible for Study
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Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>88 cases of umbilical granulomas who were treated with double ligation | Procedure: Double Ligation<br> <br> |
| Active Comparator: Group 2<br>88 cases of umbilical granulomas who were treated with topical silver nitrate | Drug: Topical Silver Nitrate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Double Ligation, Topical Silver Nitrate