The aim of the study is to investigate the effect of fibrin glue in the prevention of Seroma after the mastectomy. In this study, 60 patients with Breast cancer are recruited from Imam Reza, Sina and Shams hospitals of Tabriz and randomly assigned into intervention or control group. The patients in the control group will undergo modified radical mastectomy with drain and the intervention group will undergo radical mastectomy and Lymphadenectomy and drain was fitted with fibrin glue injection of 2cc fibrin glue is in the axillary fossa. The drain is removed when daily discharge is less than 50cc are out. The patients will be visited four times in a month after the surgery and the presence of seroma in axillary area will be examined and if there is any seroma sonography will be done for the volume of seroma.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010184511N7
Registration date:2010-10-26, 1389/08/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-10-26, 1389/08/04
Registrant information
Name
Farhang Parsafar
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 1317
Email address
parsafarf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Student Research Committee, Tabriz University of Medical Sciences
Expected recruitment start date
2010-06-22, 1389/04/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of fibrin glue in seroma prevention after mastectomy
Public title
Effect of fibrin glue in seroma prevention after breast cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: presence of breast cancer
Exclusion criteria: Presence of any complications, Patient’s dissatisfaction
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single 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
Imam Reza Hospital, University St., Tabriz
City
Tabriz
Postal code
3345654387
Approval date
2010-06-10, 1389/03/20
Ethics committee reference number
12/ج/22
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Seroma
Timepoint
1 week
Method of measurement
examination- sonography
Secondary outcomes
1
Description
Lymphedema
Timepoint
1 week
Method of measurement
Examination
Intervention groups
1
Description
Control group: patients with breast cancer undergoing mastectomy and drainage
Category
Treatment - Surgery
2
Description
Intervention group: Patients with breast cancer undergoing mastectomy that fibrin glue were injected at the end of surgery and drains are built
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Emamreza hospital
Full name of responsible person
Farhang parsafar
Street address
Imam Reza Hospital, University St., Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Student Research Committee, Tabriz University of Medical Sciences.
Full name of responsible person
Dr. Taghipur
Street address
Student Research Committee, Health and Nutrition department, Tabriz University of Medical Sciences, University St., Tabriz
City
Tabriz
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Student Research Committee, 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
Farhang Parsafar
Position
Surgery Assistant
Other areas of specialty/work
Street address
Imam Reza Hospital, University St., Tabriz
City
Tabriz
Postal code
137987656787
Phone
+98 41 1335 1317
Fax
+98 41 1335 1317
Email
parsafarf@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hemmat Maghsudi
Position
Associate Professor of Surgery
Other areas of specialty/work
Street address
Sina hospital, Azadi St., Tabriz
City
Tabriz
Postal code
34543876987
Phone
+98 41 1541 2104
Fax
+98 41 1541 2105
Email
Farhang_parsafar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sceinces
Full name of responsible person
Farhang Parsafar
Position
surgery assistant
Other areas of specialty/work
Street address
Imam Reza Hospital, University St., Tabriz
City
Tabriz
Postal code
1355659876
Phone
+98 41 1335 1317
Fax
+98 41 1335 1317
Email
parsafarf@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)