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Silver Nitrate Versus Topical Steroid For Umbilical Granuloma

NCT06363539 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 354

Last updated 2024-04-12

No results posted yet for this study

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

Interventions

DRUG

Clobetasol Propionate .05 Mg in 100 mL TOPICAL LOTION

steroid used for umblical granuloma

DRUG

Silver Nitrate

silver nitrate used for treatment

Sponsors & Collaborators

  • Children Hospital and Institute of Child Health, Lahore

    lead OTHER

Principal Investigators

  • Adeel A Gujjar, M.S · Dr Adeel Gujjar MBBS MS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-20
Primary Completion
2023-03-20
Completion
2023-05-01

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06363539 on ClinicalTrials.gov