Silver Nitrate Versus Topical Steroid For Umbilical Granuloma

NCT06363539 | Completed Phase 2

• 1 other identifier: Adeel5
• Study Type: interventional
• Target: 354
• Locations: 1 country
• Sites: 1

Brief Summary

Umbilical granuloma is most frequent abnormality of umbilicus in infants that is defined as a moist, fleshy and pink granulation tissue at the center of umbilicus. The most commonly used treatment for umbilical granuloma is silver nitrate cauterization. Various other treatment options for umbilical granuloma include dressing with alcohol and antiseptic solutions, topical table salt, topical steroid application, suture ligation, surgical excision, electrocautery and cryotherapy. Topical steroid ointment is easily available in market, it is cheaper and safer than silver nitrate. OBJECTIVE: To compare the outcome of treatment with silver nitrate versus topical steroid for umbilical granuloma in terms of healing after 3 weeks of treatment. MATERIALS AND METHODS Study Design: Randomized Controlled Trial Setting: Department of Pediatric Surgery, Children Hospital, Lahore Duration: 6 months after approval of synopsis \[Sept 20, 2022 till March 20, 2023\] DATA COLLECTION PROCEDURE 2 After approval of study from hospital Ethical committee \& CPSP, all patients fulfilling the inclusion criteria were admitted through the pediatric surgery outpatient department of The Children's Hospital Lahore. 354 Patients were divided in two equal groups randomly, using lottery method Group A (control group) in which silver nitrate was applied to the lesion once a week and Group B (experimental group) in which topical steroid ointment was applied to the lesion twice a day. Patients were followed after 3 weeks to see healing of umbilical granuloma. Photographs were taken before start of treatment and on regular intervals at each follow up visit. All data was collected by myself.

Conditions

Umbilical Granuloma

Keywords

umblical granuloma; silver nitrate; topical steroid

Outcome Measures

Primary Outcomes (1)

• healing

  rate of healing observed

  3 weeks

Study Arms (2)

topical steroid

EXPERIMENTAL

topical steroid used for treatment of granuloma

Drug: Clobetasol Propionate .05 Mg in 100 mL TOPICAL LOTION

silver nitrate

EXPERIMENTAL

silver nitrate used for umblical granuloma treatment

Drug: Silver Nitrate

Interventions

Clobetasol Propionate .05 Mg in 100 mL TOPICAL LOTION DRUG

steroid used for umblical granuloma

Also known as: clobederm

topical steroid

Silver Nitrate DRUG

silver nitrate used for treatment

Also known as: silver nitrat

silver nitrate

Eligibility Criteria

• Age: 1 Month - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Umbilical granuloma as per operational definition 2. Age below 1year 3. Both male and female genders

You may not qualify if:

• Prior treatment of umbilical granuloma either medical or surgical. 2. Umbilical anomalies as vitelline duct anomalies, urachal anomalies, soft benign tumors of umbilicus 3. Syndromic Child with any other co-morbid condition.

Sponsors & Collaborators

• Children Hospital and Institute of Child Health, Lahore: lead

Study Sites (1)

Children Hospital

Lahore, Punjab Province, 42000, Pakistan

Location

MeSH Terms

Interventions

Clobetasol; Silver Nitrate

Intervention Hierarchy (Ancestors)

Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Nitrates; Nitric Acid; Nitrogen Compounds; Inorganic Chemicals; Silver Compounds

Study Officials

• Adeel A Gujjar, M.S

  Dr Adeel Gujjar MBBS MS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Muhammad Adeel Ashiq

Model Details: randomized control trial

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 12, 2024
• Study Start: September 20, 2022
• Primary Completion: March 20, 2023
• Study Completion: May 1, 2023
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)