Double Ligation and Topical Silver Nitrate (RCT)

January 29, 2020 updated by: Muhammad Rashid, Shaheed Zulfiqar Ali Bhutto Medical University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

176

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Procedure: Double Ligation
Active Comparator: Group 2
88 cases of umbilical granulomas who were treated with topical silver nitrate
Drug: 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

This is where you will find people and organizations involved with this study.

Sponsor

Shaheed Zulfiqar Ali Bhutto Medical University

Investigators

  • Study Director: Nadeem Akhtar, MS Paediatric Surgery, Professor of Paediatric Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

January 28, 2020

First Submitted That Met QC Criteria

January 29, 2020

First Posted (Actual)

January 30, 2020

Study Record Updates

Last Update Posted (Actual)

January 30, 2020

Last Update Submitted That Met QC Criteria

January 29, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Umbilical Granuloma

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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