Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06363539 |
| Other study ID # |
Adeel5 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
September 20, 2022 |
| Est. completion date |
May 1, 2023 |
Study information
| Verified date |
April 2024 |
| Source |
Children Hospital and Institute of Child Health, Lahore |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Umbilical granuloma is most frequent abnormality of umbilicus in infants with prevalence of 1
in 500 newborns.1 Umbilical granuloma is defined as a moist, fleshy and pink granulation
tissue at the center of umbilicus.2,3 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 umbilicus.4 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 weeks.1,5,6 Umbilical granuloma predominantly consists of
fibroblasts, copious blood vessels, endothelial and inflammatory cells in an edematous stroma
with no neural elements.3,7,8 Delayed cord separation i.e. persisting cord beyond 2 - 3
weeks, occurs in the presence of an ongoing subclinical or mild infection in umbilical stump,
leading to granuloma formation.7,9 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 umbilicus.10,11 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 umbilicus.6,12-15 The
most commonly used treatment for umbilical granuloma is silver nitrate cauterization. 4,12
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 professionals.16-18 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 cryotherapy.5,12,15,19 Topical steroid ointment for the treatment of
umbilical granuloma has gained wide attention due to its advantages of effectiveness and
simplicity.20,21Topical steroid exerts anti-inflammatory effects and reduce the number of
fibroblasts so its beneficial for treating umbilical granuloma.8,22 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 avoided.4 In a study the healing rate
after 3 weeks of treatment with topical steroid ointment were almost identical to that silver
nitrate cauterization as 90.4% versus 91% with no major complication.23 Another study shows;
The healing rate at 3 weeks after treatment with silver nitrate and clobetasol propionate
0.05%(steroid) were compatible as 96.6% and 90% respectively with mild side effects of skin
pigmentation and atrophy.21 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.
