Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363539
Status:
COMPLETED
Last Update Posted:
2024-04-12
First Post:
2024-04-09
Brief Title:
Silver Nitrate Versus Topical Steroid For Umbilical Granuloma
Sponsor:
Children Hospital and Institute of Child Health Lahore
Organization:
Children Hospital and Institute of Child Health Lahore
Study Overview
Official Title:
Outcome Of Treatment With Silver Nitrate Versus Topical Steroid For Umbilical Granuloma In Terms Of Healing After 3 Weeks Of Treatment
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Childrens 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
Detailed Description:
Umbilical granuloma is most frequent abnormality of umbilicus in infants with prevalence of 1 in 500 newborns1 Umbilical granuloma is defined as a moist fleshy and pink granulation tissue at the center of umbilicus23 Many congenital conditions such as patent urachus and persistent vitellointestinal duct can mimic umbilical granuloma but they present with discharge of urine or feces having different smell from the umbilicus4 Characteristically the granulomas become apparent after separation of umbilical cord Once umbilical cord is clamped during delivery a rapid separation begins and cord spontaneously detaches within7 to15 days and disappears by 2 to 3 weeks156 Umbilical granuloma predominantly consists of fibroblasts copious blood vessels endothelial and inflammatory cells in an edematous stroma with no neural elements378 Delayed cord separation ie persisting cord beyond 2 - 3 weeks occurs in the presence of an ongoing subclinical or mild infection in umbilical stump leading to granuloma formation79 Most common symptoms of umbilical granuloma are small swelling and discharge Physical examination shows a small 1 to 10mm soft friable non-tender and pale pink lesion at base of umbilicus1011 It can be diagnosed easily with careful history physical examination of umbilicus 5 and type of discharge and frequently requires no further investigation If there is any doubt about diagnosis then other diagnostic modalities can be used such as ultrasound abdomen contrast studies and excisional biopsy can be used to rule out other anomalies of umbilicus including urachal anomalies vitelline duct anomalies and benign soft tissue tumors of umbilicus612-15 The most commonly used treatment for umbilical granuloma is silver nitrate cauterization 412 Chemical burns to the periumbilical area eyelids and pigmentation changes are reported complications of silver nitrate cauterization Therefore clinic application of silver nitrate is advised on outdoor basis by trained health professionals16-18 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 cryotherapy5121519 Topical steroid ointment for the treatment of umbilical granuloma has gained wide attention due to its advantages of effectiveness and simplicity2021Topical steroid exerts anti-inflammatory effects and reduce the number of fibroblasts so its beneficial for treating umbilical granuloma822 Topical steroids can be applied at home by parents requiring no supervision of health care professionals However prolonged 6 application of topical steroid can lead to skin infections hypopigmentation atrophy and Cushing syndrome so long term use should be avoided4 In a study the healing rate after 3 weeks of treatment with topical steroid ointment were almost identical to that silver nitrate cauterization as 904 versus 91 with no major complication23 Another study shows The healing rate at 3 weeks after treatment with silver nitrate and clobetasol propionate 005steroid were compatible as 966 and 90 respectively with mild side effects of skin pigmentation and atrophy21 Although multiple studies are conducted to assess the efficacy of silver nitrate cauterization but limited study is available to compare the efficacy of topical steroid treatment for umbilical granuloma My study may help to assess the efficacy of topical steroid ointment in the treatment of umbilical granuloma Topical steroid ointment is easily available in market it is cheaper and safer than silver nitrate It may help to assure the parental satisfaction as they can apply it at home safely and may reduce the burden on hospital moreover no similar study has been conducted in our hospital yet and thus it may be add to the limited clinical data available and improves patient care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None