Double Ligation and Topical Silver Nitrate

Phase 2

Completed

• Conditions: Umbilical Granuloma
• Interventions: Drug: Topical Silver Nitrate; Procedure: Double Ligation

• Registration Number: NCT04248101
• Lead Sponsor: Shaheed Zulfiqar Ali Bhutto Medical University

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

Study Timeline

• Study Start: 2016-07-01
• Primary Completion: 2017-06-30
• Study Completion: 2017-07-01
• Status Verified: 2020-01
• Study First Submitted: 2020-01-28
• Study First Submitted QC: 2020-01-29
• Last Update Submitted: 2020-01-29
• Study First Posted: 2020-01-30
• Last Update Posted: 2020-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Topical Silver Nitrate	88 cases of umbilical granulomas who were treated with topical silver nitrate
Group 1	Double Ligation	88 cases of umbilical granulomas who were treated with double ligation

Primary Outcome Measures

Name	Time	Method
Frequency of Success/Failure of treatment	3 weeks	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.
Frequency of complications in both groups	3 weeks	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