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Double Ligation and Topical Silver Nitrate (RCT)

Primary Purpose

Umbilical Granuloma

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Double Ligation
Topical Silver Nitrate
Sponsored by
Shaheed Zulfiqar Ali Bhutto Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Umbilical Granuloma focused on measuring Double Ligation, Topical Silver Nitrate

Eligibility Criteria

undefined - 12 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Group 1

    Group 2

    Arm Description

    88 cases of umbilical granulomas who were treated with double ligation

    88 cases of umbilical granulomas who were treated with topical silver nitrate

    Outcomes

    Primary Outcome Measures

    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.
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    January 28, 2020
    Last Updated
    January 29, 2020
    Sponsor
    Shaheed Zulfiqar Ali Bhutto Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04248101
    Brief Title
    Double Ligation and Topical Silver Nitrate
    Acronym
    RCT
    Official Title
    Comparison of Double Ligation and Topical Silver Nitrate for Treatment of Umbilical Granuloma in Children: A Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2016 (Actual)
    Primary Completion Date
    June 30, 2017 (Actual)
    Study Completion Date
    July 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shaheed Zulfiqar Ali Bhutto Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Umbilical Granuloma
    Keywords
    Double Ligation, Topical Silver Nitrate

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    176 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Active Comparator
    Arm Description
    88 cases of umbilical granulomas who were treated with double ligation
    Arm Title
    Group 2
    Arm Type
    Active Comparator
    Arm Description
    88 cases of umbilical granulomas who were treated with topical silver nitrate
    Intervention Type
    Procedure
    Intervention Name(s)
    Double Ligation
    Intervention Type
    Drug
    Intervention Name(s)
    Topical Silver Nitrate
    Primary Outcome Measure Information:
    Title
    Frequency of Success/Failure of treatment
    Description
    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.
    Time Frame
    3 weeks
    Title
    Frequency of complications in both groups
    Description
    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
    Time Frame
    3 weeks

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    12 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nadeem Akhtar, MS Paediatric Surgery
    Organizational Affiliation
    Professor of Paediatric Surgery
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Double Ligation and Topical Silver Nitrate

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