Double Ligation and Topical Silver Nitrate
RCT
Comparison of Double Ligation and Topical Silver Nitrate for Treatment of Umbilical Granuloma in Children: A Randomized Control Trial
1 other identifier
interventional
176
0 countries
N/A
Brief Summary
To study and compare the efficacy and safety of Double Ligation and Topical Silver Nitrate Solution while treating children with Umbilical Granulomas
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2016
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 28, 2020
CompletedFirst Posted
Study publicly available on registry
January 30, 2020
CompletedJanuary 30, 2020
January 1, 2020
12 months
January 28, 2020
January 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Group 1
ACTIVE COMPARATOR88 cases of umbilical granulomas who were treated with double ligation
Group 2
ACTIVE COMPARATOR88 cases of umbilical granulomas who were treated with topical silver nitrate
Interventions
Eligibility Criteria
You may qualify if:
- \. Patients of Umbilical Granuloma, less than 1 year age
You may not qualify if:
- Patients who already had any treatment
- Parents refused to give consent for enrollment
- Patients lost in follow up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nadeem Akhtar, MS Paediatric Surgery
Professor of Paediatric Surgery
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Scholar MS Paediatric Surgery
Study Record Dates
First Submitted
January 28, 2020
First Posted
January 30, 2020
Study Start
July 1, 2016
Primary Completion
June 30, 2017
Study Completion
July 1, 2017
Last Updated
January 30, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share