The aim of this study was to determine the effect of topical phenytoin solution on serous fluid drainage modified radical mastectomy in patients with breast cancer and duration drains to patients and its impact on reducing the incidence of seroma formationInclusion: All patients with breast cancer undergoing modified radical mastectomy ; without a history of allergy to phenytoin ; without comorbodities
Exclusion criteria: patients who are not surgical; have a history of comorbidities; have a history of allergy to phenytoin. Double-blind study in 31 patients performed. For placebo of saline used. Time intervention drains and close skin solution is injected through the drain. The expected results are reducing the amount of fluid and seroma formation in the future.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201601111786N6
Registration date:2016-01-29, 1394/11/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-01-29, 1394/11/09
Registrant information
Name
Nasrin Rahmani
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1226 1700
Email address
nrahmani@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of topical phenytoin solution on the drainage serous fluid modified radical mastectomy in patients with breast cancer
Public title
Topical Solution phenytoin effect on fluid after breast cancer surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: All patients with breast cancer undergoing modified radical mastectomy ; without a history of allergy to phenytoin ; without comorbodities
Exclusion criteria: patients who are not surgical; have a history of comorbidities; have a history of allergy to phenytoin
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
31
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences
Street address
, The Imam Khomeini three ways Jouybar, the beginning of the highway Valieasr, Mazandaran University of Medical Sciences
City
Sari
Postal code
4817844718
Approval date
2015-07-05, 1394/04/14
Ethics committee reference number
IR.MAZUMS REC.94
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
DRAIN SECTRETION
Timepoint
first second and third day after surgery
Method of measurement
cc per 24 hours
2
Description
The number of days to drain
Timepoint
The day after surgery to drain down time
Method of measurement
day
3
Description
seroma formation
Timepoint
14 days after discharge
Method of measurement
clinical examination
Secondary outcomes
1
Description
seroma formation
Timepoint
14 days after discharge
Method of measurement
clinical examination
2
Description
The remaining drain time
Timepoint
The first day after surgery to drain down time
Method of measurement
day
Intervention groups
1
Description
15 ml of Phenytoin solution1% injected through the drain at the first day after surgery
Category
Treatment - Drugs
2
Description
In the control group 15cc of normal saline injected through drain at the first day after surgery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital in Sari
Full name of responsible person
Dr.N Rahmani
Street address
Imam Khomeini Hospital in Sari
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.R Esmaeili
Street address
Imam (RA) three ways Jooybar, the beginning of the highway Valieasr, Mazandaran University of Medical Sciences
City
Sari
Grant name
10506
Grant code / Reference number
1294502
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of medical science
Full name of responsible person
Dr.H Karimi
Position
general surgery resident
Other areas of specialty/work
Street address
Imam Khomeini Hospital of Sari
City
Sari
Postal code
Phone
+98 11 3336 1700
Fax
Email
NRahmani@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of medical science
Full name of responsible person
Dr.N Rahmani
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Khomeini Hospital of Sari
City
Sari
Postal code
Phone
+98 11 3336 1700
Fax
Email
NRahmani@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of medical science
Full name of responsible person
Dr.S Namazi Baigi
Position
general surgery resident
Other areas of specialty/work
Street address
Imam Khomeini Hospital in Sari
City
Sari
Postal code
Phone
+98 11 3336 1700
Fax
Email
dr.s.namazi.gsurgeon@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)