The aim of present study is to compare the clinical results of salt therapy with surgery in treatment of umbilical granuloma in infants. In a single center randomized clinical trial study, 50 patients with umbilical granuloma who referred to Children Hospital educational-medical center of Tabriz University of Medical Sciences will select randomly and with using randomly per muted blocks will allocate in two groups. Inclusion criteria are, infant age between 3 weeks to 4 month, diagnosis of umbilical granuloma, and parental informed consent for study. Exclusion criteria are infants older than 4 months, and other diagnosis except of umbilical granuloma. Patients were randomly will allocate in one of group. In first group umbilical granuloma will treat with salt therapy (n=25) and in second group umbilical granuloma will treat by surgery using electro-cauterization method (n=25). After treatment patients will followed up for 3 months. Patients will evaluate in term of successful treatment of umbilical granuloma as primary outcome variable and also will evaluate for rate of recurrence, and side effects of each both two treatments as secondary outcome variables.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016042620663N3
Registration date:2016-05-14, 1395/02/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-05-14, 1395/02/25
Registrant information
Name
Davoud Badebarin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3526 2257
Email address
badebarind@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences.
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the clinical results of salt therapy with surgery in treatment of umbilical granuloma in infants
Public title
Comparison of the clinical results of salt therapy with surgery in treatment of umbilical granuloma in infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Infant age between 3 weeks to 4 month; diagnosis of umbilical granuloma; parental informed consent for study. Exclusion criteria: infants older than 4 months; other diagnosis except of umbilical granuloma.
Age
From 1 month old to 4 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University Of Medical Sciences
Street address
Tabriz University Of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
TBZMED.REC.1394.564
Health conditions studied
1
Description of health condition studied
Umbilical Granuloma
ICD-10 code
L92.8
ICD-10 code description
Other granulomatous disorders of skin and subcutaneous tissue
Primary outcomes
1
Description
Successful treatment of umbilical granuloma
Timepoint
Five days after treatment.
Method of measurement
Clinical examination
Secondary outcomes
1
Description
Rate of recurrence
Timepoint
Three month after surgery.
Method of measurement
Clinical examination
2
Description
Side effects of treatment
Timepoint
Three months after surgery.
Method of measurement
Clinical examination
Intervention groups
1
Description
In intervention group: after washing umbilical area of infant by lukewarm water and drying it, we put some sterilized without iodine salt on granuloma to the extent that it covered all of granuloma surface, and after half an hour, will be washed with lukewarm water and will dried. This will be repeated every 12 hours for five days.
Category
Treatment - Other
2
Description
In control group: after general anesthesia, umbilical granuloma will be resect, using electric cautery.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Children Hospital
Full name of responsible person
Dr. Davoud Badebarin
Street address
Department Of Surgery, Tabriz University of Medical Sciences.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University Of Medical Sciences.
Full name of responsible person
Dr Hasan Soleimanpour
Street address
Deputy of Research and Technology, Central Building of Number Two, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz University Of Medical Sciences.
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University Of Medical Sciences.
Full name of responsible person
Dr Mohammad Mehdi Shakeri
Position
Resident of Surgery Medicine
Other areas of specialty/work
Street address
Faculty of Medicine, Tabriz University Of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Postal code
Phone
+98 41 3334 1317
Fax
Email
dbadebarin@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department Of Surgery, Tabriz University of Medical Sciences.
Full name of responsible person
Dr. Davoud Badebarin
Position
Pediatric Surgery Sub-specialist.
Other areas of specialty/work
Street address
Department of Surgery, Imam Reza Hospital, Daneshgah Street, Tabriz.
City
Tabriz
Postal code
Phone
+98 41 3334 1317
Fax
Email
badebarind@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammad Mehdi Shakeri
Position
Resident of Surgery Medicine
Other areas of specialty/work
Street address
Faculty of Medicine, Tabriz University Of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Postal code
Phone
+98 41 3334 1317
Fax
Email
dbadebarin@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)