Umbilical GranulomaPhase 2RCTNCT04248101

Double Ligation and Topical Silver Nitrate

A Phase 2 study testing Double Ligation and Topical Silver Nitrate in people with Umbilical Granuloma, run by Shaheed Zulfiqar Ali Bhutto Medical University.

Completed

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

Official record

Search all trials

Trial summary

To study and compare the efficacy and safety of Double Ligation and Topical Silver Nitrate Solution while treating children with Umbilical Granulomas Read more about this study

Who is it for?: Ages Up to 12 months
Conditions the study is for: Umbilical Granuloma
What is being tested?: Double Ligation and Topical Silver Nitrate
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 176 participants
Where: No sites listed yet
Study dates: 1 Jul 2016to 1 Jul 2017
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 Up to 12 months
All sexes
No healthy volunteers
Child

Who may be able to join

1. Patients of Umbilical Granuloma, less than 1 year age

Who cannot join

Patients who already had any treatment
Parents refused to give consent for enrollment
Patients lost in follow up

About this study

Official title: Comparison of Double Ligation and Topical Silver Nitrate for Treatment of Umbilical Granuloma in Children: A Randomized Control Trial

To study and compare the efficacy and safety of Double Ligation and Topical Silver Nitrate Solution while treating children with Umbilical Granulomas

Read the detailed description

The patients underwent one treatment option and then followed up for three weeks and the results noted in terms of success/failure and complications specific to each treatment option and analysed accordingly

Conditions: Umbilical Granuloma
Being tested: Double Ligation, Topical Silver Nitrate
Keywords: Double Ligation, Topical Silver Nitrate

What participants receive

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

Double LigationProcedure or surgery
Topical Silver NitrateDrug

Study groups in NCT04248101
Study group	Role	What they receive
Group 1	Active comparator	88 cases of umbilical granulomas who were treated with double ligation Receives: Procedure: Double Ligation
Group 2	Active comparator	88 cases of umbilical granulomas who were treated with topical silver nitrate Receives: Drug: Topical Silver Nitrate

What is being measured

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

Frequency of Success/Failure of treatment
The effect of treatment was noted in a structured proforma on weekly basis for 3 weeks.
Treatment was considered successful if, on local examination the granuloma disappeared completely and did not reappear during the follow up period.
And if the granuloma did not disppear completely during the follow up period after double ligation or application of silver nitrate, treatment was considered to have failed.
These variables were measured as frequency and percentages. The results were compared between the two groups using chi-square test. A significance level of <0.05 was considered significant.
Measured: 3 weeks
Frequency of complications in both groups
The complications were also noted in the above mentioned proforma during the follow up period on weekly basis for 3 weeks.
Complications relevant to the treatment i.e. infection, bleeding, chemical burns and skin discoloration were noted during local examination.
These variables were measured as frequency and percentages. The results were compared between the two groups using chi-square test. A significance level of <0.05 was considered significant
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 Jul 20161 Jul 2017

First posted30 Jan 2020
Study start1 Jul 2016
Primary completion30 Jun 2017
Study completion1 Jul 2017

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
Masking: None (open label)
Enrolment: 176 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04248101
Sponsor's protocol ID: Umbilical Granuloma
Acronym: RCT
Status last verified: Jan 2020
First submitted: 28 Jan 2020
Last updated: 30 Jan 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Double Ligation and Topical Silver Nitrate for Treatment of Umbilical Granuloma in Children: A Randomized Control Trial
ClinicalTrials.gov ID: NCT04248101
Acronym / sponsor ID: RCT / Umbilical Granuloma
Conditions: Umbilical Granuloma
Keywords: Double Ligation, Topical Silver Nitrate
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 176 participants (actual)
Lead sponsor: Shaheed Zulfiqar Ali Bhutto Medical UniversityUniversity, hospital or other
Study start: 1 Jul 2016 (actual)
Primary completion: 30 Jun 2017 (actual)
Study completion: 1 Jul 2017 (actual)
First posted: 30 Jan 2020 (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.

To study and compare the efficacy and safety of Double Ligation and Topical Silver Nitrate Solution while treating children with Umbilical Granulomas

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 1	Active comparator	Procedure: Double Ligation88 cases of umbilical granulomas who were treated with double ligation
Group 2	Active comparator	Drug: Topical Silver Nitrate88 cases of umbilical granulomas who were treated with topical silver nitrate

Who may qualify

Ages: Up to 12 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

1. Patients of Umbilical Granuloma, less than 1 year age

Key exclusion criteria (3 listed)

Patients who already had any treatment
Parents refused to give consent for enrollment
Patients lost in follow up

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
Double Ligation	Procedure or surgery	Group 1
Topical Silver Nitrate	Drug	Group 2

Primary outcome

Frequency of Success/Failure of treatment
Time frame: 3 weeks
The effect of treatment was noted in a structured proforma on weekly basis for 3 weeks. Treatment was considered successful if, on local examination the granuloma disappeared completely and did not reappear during the follow up period. And if the granuloma did not disppear completely during the follow up period after double ligation or application of silver nitrate, treatment was considered to have failed. These variables were measured as frequency and percentages. The results were compared between the two groups using chi-square test. A significance level of <0.05 was considered significant.
Frequency of complications in both groups
Time frame: 3 weeks
The complications were also noted in the above mentioned proforma during the follow up period on weekly basis for 3 weeks. Complications relevant to the treatment i.e. infection, bleeding, chemical burns and skin discoloration were noted during local examination. These variables were measured as frequency and percentages. The results were compared between the two groups using chi-square test. A significance level of <0.05 was considered significant

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 30 Jan 2020.
Individual participant dataSharing planned: No

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.

Nadeem Akhtar, MS Paediatric Surgery study director

Professor of Paediatric Surgery

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Double Ligation and Topical Silver Nitrate in people with Umbilical Granuloma, run by Shaheed Zulfiqar Ali Bhutto Medical University.

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 3 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 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

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?

Frequency of Success/Failure of treatment (time frame: 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04248101.

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 30 Jan 2020.