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Completed

NCT Number: NCT04248101

Double Ligation and Topical Silver Nitrate

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

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Key information

Conditions

Umbilical Granuloma

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Double Ligation

Procedure

Topical Silver Nitrate

Drug

Primary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Shaheed Zulfiqar Ali Bhutto Medical University

Other

Registry information

Official study title

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

Acronym: RCT

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 30, 2020
Registry last updated
Jan 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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