BCG vaccination is the national immunization program in Iran and its lymphadenopathy is relatively common finding in children. Variety of Therapies for the treatment of suppurative lymphadenitis caused by BCG vaccination has been recommended. Given the existing differences, we decided to design a study to evaluate and compare different surgical procedures effects on (needle aspiration, incision and drainage or excision) the treatment of suppurative lymphadenitis caused by BCG vaccination.
Inclusion criteria: All children involved with BCG lymphadenitis
Exclusion criteria: The development of any systemic diseases such as malignant lymphadenopathy is the author of it; patients with a history of tuberculous meningitis or milliary tuberculosis
All of the children that admitted to children Hospital of Tabriz during February of 2013 to 2014February with diagnosis of suppurative lymphadenitis induced by BCG, After recording there information about age, sex, previous treatment and site of the lymphadenitis They will randomly assigned into three groups:
The first group will be treated with needle aspiration
The second group will be treated by the method of incision and drainage
The third group will undergo total excision of lymphadenitis
In continue patients will be follow up for 6 months. In this term rate of recovery, side effects of surgery (Damage to nerves, scar, and formation of colloid) and relapse is examined.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015011420663N1
Registration date:2015-04-29, 1394/02/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-04-29, 1394/02/09
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
Tabriz University of Medical Science
Expected recruitment start date
2013-01-20, 1391/11/01
Expected recruitment end date
2014-01-21, 1392/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of surgical techniques in the treatment of suppurative lymphadenitis caused by BCG vaccination
Public title
Surgical treatment of BCG induced suppurative lymphadenitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The risk of BCG lymphadenitis
Exclusion criteria: The development of any systemic diseases such as malignant lymphadenopathy is the author of it ; patients with a history of tuberculous meningitis or tuberculosis milliary
Age
From 1 day old to 6 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
39
Randomization (investigator's opinion)
N/A
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 Science
Street address
Unit of Ethics Committee, Medical Faculty, Golgasht street
City
Tabriz
Postal code
Approval date
2013-07-22, 1392/04/31
Ethics committee reference number
92102
Health conditions studied
1
Description of health condition studied
BCG induced suppurative LYMPHADENITIS
ICD-10 code
Z23.2
ICD-10 code description
[Need for immunization against tuberculosis [BCG
Primary outcomes
1
Description
Recovery from BCG lymphadenitis with 3 different surgical techniques
Timepoint
2 and 6 month after vaccine injection
Method of measurement
Clinical examination of recurrence
Secondary outcomes
1
Description
Reviewing the formation of keloids, scars, skin indentations, deformity, edema
Timepoint
after six month
Method of measurement
clinical examination
Intervention groups
1
Description
In the first group lymphadenitis caused by BCG vaccination can be treated by using needle aspiration, So that lymph node will be aspirated with needle number 21
Category
Treatment - Surgery
2
Description
In the second group in the first group lymphadenitis caused by BCG vaccination can be treated by using incision & drainage, So that lymph node will be incised on the maximum point of fluctuation. Site of the incision will be washed with normal saline then we place a drain in order to drainage our site.
Category
Treatment - Surgery
3
Description
In the third group lymph node will totally excised, first, the patient is underwent general anesthesia, then we will incise the skin and disconnect lymph nodes supportive tissues. Finally lymph nodes totally removed.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
children Hospital of Tabriz(Farman Farmanian)
Full name of responsible person
Dr .Aslan Abadi
Street address
Tabriz children hospital
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Science
Full name of responsible person
Dr. Aslan abadi
Street address
Tabriz children hospital(Farman Farmanian)
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Science
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 Science
Full name of responsible person
Dr. Hosein Shiri
Position
General Surgery Resident
Other areas of specialty/work
Street address
General surgery department, Emam Reza hosiptal, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 3334 1317
Fax
Email
hosein_shiri@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Science
Full name of responsible person
Dr. Saiid Aslan Abadi
Position
Sub Specialist of Children Surgey
Other areas of specialty/work
Street address
Department of Pediatrics, Children Hospital of Tabriz, shesh kilan street
City
Tabriz
Postal code
Phone
+98 41 3526 2250
Fax
Email
badebarind@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)