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.
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.
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.
- Conditions
- Umbilical Granuloma
- 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 group | Role | What they receive |
|---|---|---|
| topical steroid | Experimental | topical steroid used for treatment of granuloma Receives: Drug: Clobetasol Propionate .05 Mg in 100 mL TOPICAL LOTION |
| silver nitrate | Experimental | silver 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.
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.
- First posted12 Apr 2024
- Study start20 Sep 2022
- Primary completion20 Mar 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Umbilical GranulomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Children Hospital and Institute of Child Health, Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Adeel Ashiq, Children Hospital and Institute of Child Health, Lahore
- Investigators
- Adeel A Gujjar, M.S, Principal investigator, Dr Adeel Gujjar MBBS MS
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Of Treatment With Silver Nitrate Versus Topical Steroid For Umbilical Granuloma In Terms Of Healing After 3 Weeks Of Treatment
- ClinicalTrials.gov ID
- NCT06363539
- Acronym / sponsor ID
- Adeel5
- Conditions
- Umbilical Granuloma
- Keywords
- umblical granuloma, silver nitrate, topical steroid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Children Hospital and Institute of Child Health, LahoreUniversity, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized control trial
| Arm | Type | Receives |
|---|---|---|
| topical steroid | Experimental | Drug: Clobetasol Propionate .05 Mg in 100 mL TOPICAL LOTIONtopical steroid used for treatment of granuloma |
| silver nitrate | Experimental | Drug: Silver Nitratesilver nitrate used for umblical granuloma treatment |
Who may qualify
- Ages
- 1 month to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Umbilical granuloma as per operational definition 2. Age below 1year 3. Both male and female genders
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clobetasol Propionate .05 Mg in 100 mL TOPICAL LOTIONAlso: clobedermsteroid used for umblical granuloma | Drug | topical steroid |
| Silver NitrateAlso: silver nitratsilver nitrate used for treatment | Drug | silver nitrate |
Primary outcome
healing
Time frame: 3 weeks
rate of healing observed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: No. no plan of sharing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adeel A Gujjar, M.S principal investigator
Dr Adeel Gujjar MBBS MS
1 site in 1 country: see every site and its status.
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.