Double Ligation and Topical Silver Nitrate

Umbilical Granuloma Clinical Trial

— RCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04248101
• Other study ID #: Umbilical Granuloma
• Status: Completed
• Phase: Phase 2
• Start date: July 1, 2016
• Est. completion date: July 1, 2017

Study information

• Verified date: January 2020
• Source: Shaheed Zulfiqar Ali Bhutto Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: July 1, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Granuloma
• Umbilical Granuloma

Intervention

Procedure:
• Double Ligation

Drug:
• Topical Silver Nitrate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shaheed Zulfiqar Ali Bhutto Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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