Double Ligation and Topical Silver Nitrate

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

Sponsors

Lead Sponsor: Shaheed Zulfiqar Ali Bhutto Medical University

Source Shaheed Zulfiqar Ali Bhutto Medical University
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

Overall Status Completed
Start Date 2016-07-01
Completion Date 2017-07-01
Primary Completion Date 2017-06-30
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Frequency of Success/Failure of treatment 3 weeks
Frequency of complications in both groups 3 weeks
Enrollment 176
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Double Ligation

Arm Group Label: Group 1

Intervention Type: Drug

Intervention Name: Topical Silver Nitrate

Arm Group Label: Group 2

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

N/A

Maximum Age:

12 Months

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Nadeem Akhtar, MS Paediatric Surgery Study Director Professor of Paediatric Surgery
Verification Date

2020-01-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Shaheed Zulfiqar Ali Bhutto Medical University

Investigator Full Name: Muhammad Rashid

Investigator Title: Scholar MS Paediatric Surgery

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Group 1

Type: Active Comparator

Description: 88 cases of umbilical granulomas who were treated with double ligation

Label: Group 2

Type: Active Comparator

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

Acronym RCT
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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