Double Ligation and Topical Silver Nitrate (RCT)

Shaheed Zulfiqar Ali Bhutto Medical University

Status and phase: Completed; Phase 2

Conditions: Umbilical Granuloma

Treatments: Drug: Topical Silver Nitrate; Procedure: Double Ligation

Study type: Interventional

Funder types: Other

Identifiers

NCT04248101

Umbilical Granuloma

Details and patient eligibility

About

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

Full 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

Enrollment: 176 patients

Sex: All

Ages: Under 12 months old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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176 participants in 2 patient groups

Group 1

Active Comparator group

Description:

88 cases of umbilical granulomas who were treated with double ligation

Treatment:

Procedure: Double Ligation

Group 2

Active Comparator group

Description:

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

Treatment:

Drug: Topical Silver Nitrate