Comparison of Double Ligation and Topical Silver Nitrate for Treatment of Umbilical Granuloma in Children: A Randomized Control Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 176
- Primary Endpoint
- Frequency of Success/Failure of treatment
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 12 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Arms & Interventions
Group 1
88 cases of umbilical granulomas who were treated with double ligation
Intervention: Double Ligation (Procedure)
Group 2
88 cases of umbilical granulomas who were treated with topical silver nitrate
Intervention: Topical Silver Nitrate (Drug)
Outcomes
Primary Outcomes
Frequency of Success/Failure of treatment
Time Frame: 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
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported
Investigators
Muhammad Rashid
Scholar MS Paediatric Surgery
Shaheed Zulfiqar Ali Bhutto Medical University