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Umbilical GranulomaPhase 2NCT06363539

Silver Nitrate Versus Topical Steroid For Umbilical Granuloma

A Phase 2 study testing Clobetasol Propionate .05 Mg in 100 mL TOPICAL LOTION and Silver Nitrate in people with Umbilical Granuloma, run by Children Hospital and Institute of Child Health, Lahore at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 1 month to 1 year
Conditions the study is for
Umbilical Granuloma
What is being tested?
Clobetasol Propionate .05 Mg in 100 mL TOPICAL LOTION and Silver Nitrate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
354 participants
Where
1 sitePakistan
Study dates
20 Sep 2022to 1 May 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 month to 1 year
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • 1.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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Children Hospital

    Lahore, Punjab Province, 42000

Other trials in Pakistan

About this study

Official title: Outcome Of Treatment With Silver Nitrate Versus Topical Steroid For Umbilical Granuloma In Terms Of Healing After 3 Weeks Of Treatment

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.

Read the detailed 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.

Being tested
Clobetasol Propionate .05 Mg in 100 mL TOPICAL LOTION, Silver Nitrate
Keywords
umblical granuloma, silver nitrate, topical steroid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clobetasol Propionate .05 Mg in 100 mL TOPICAL LOTIONDrug

    Also called clobederm

    steroid used for umblical granuloma

  • Silver NitrateDrug

    Also called silver nitrat

    silver nitrate used for treatment

Study groups in NCT06363539
Study groupRoleWhat they receive
topical steroidExperimentaltopical steroid used for treatment of granuloma
Receives: Drug: Clobetasol Propionate .05 Mg in 100 mL TOPICAL LOTION
silver nitrateExperimentalsilver nitrate used for umblical granuloma treatment
Receives: Drug: Silver Nitrate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. healing

    rate of healing observed

    Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2024
  2. Study start20 Sep 2022
  3. Primary completion20 Mar 2023
  4. Study completion1 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized control trial
Masking
None (open label)
Enrolment
354 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06363539
Sponsor's protocol ID
Adeel5
Status last verified
Apr 2024
First submitted
9 Apr 2024
Last updated
12 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: no plan of sharing

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Clobetasol Propionate .05 Mg in 100 mL TOPICAL LOTION and Silver Nitrate in people with Umbilical Granuloma, run by Children Hospital and Institute of Child Health, Lahore at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

healing (time frame: 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.

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