- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04248101
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group 1
88 cases of umbilical granulomas who were treated with double ligation
|
|
Active Comparator: Group 2
88 cases of umbilical granulomas who were treated with topical silver nitrate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
3 weeks
|
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 |
3 weeks
|
Collaborators and Investigators
Investigators
- Study Director: Nadeem Akhtar, MS Paediatric Surgery, Professor of Paediatric Surgery
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Umbilical Granuloma
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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