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Clinical Trials/NCT04248101
NCT04248101CompletedPhase 2

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

Shaheed Zulfiqar Ali Bhutto Medical University0 sites176 target enrollmentStarted: July 1, 2016Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
176
Primary Endpoint
Frequency of Success/Failure of treatment

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
— to 12 Months (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Group 1

Active Comparator

88 cases of umbilical granulomas who were treated with double ligation

Intervention: Double Ligation (Procedure)

Group 2

Active Comparator

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

Intervention: Topical Silver Nitrate (Drug)

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Muhammad Rashid

Scholar MS Paediatric Surgery

Shaheed Zulfiqar Ali Bhutto Medical University

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