Incidence of seroma formation after flap fixation with MONOCRYLE suture in mastectomy
Design
Sample collection during 12 months was selected from clients for surgery. To determine the sample size, the sample volume formula based on power was used. The sample size in each group was 62 people. The study is a blind and the mastectomy will be performed in the usual way and the mastectomy with flap fixation will be performed with a monocrystalline suture. Patients will be randomly divided into intervention and control groups.
Settings and conduct
Patient information is recorded and discharged during the first, second and third day of hospitalization after surgery
The inside of the drone bag was measured accurately daily and in case of volume less than 30 ml daily, drain will come out.
The number of days of treatment for each patient will be recorded in the data collection form. Then Patients will be discharged within three days, regardless of the presence or absence of the disease. Since the
Withdrawal of the drain until fourteen days later
Probable seromas will be carefully examined and evaluated in the area of operation. Information Patients with seroma are recorded with the amount they need to evacuateIf necessary, it will be emptied.
Participants/Inclusion and exclusion criteria
All of breast cancer patients who are candidate mastectomy
Intervention groups
Patients in the intervention group are who had flap fixation with MONOCRYLE suture after mastectomy in breast cancer
Investigating the effect of flap fixation with MONOCRYLE suture after mastectomy in seroma formation in breast cancer patients
Public title
Seroma formation after mastectomy with flap fixation using MONOCRYLE suture in breast cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All breast cancer patients who are candidates for mastectomy
Exclusion criteria:
Diabetes
Use of Corticosteroid
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
124
Actual sample size reached:
120
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants in this study will enter the intervention and control groups non-randomly after obtaining informed consent and will not be aware of the type of intervention.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Imam Khomeini hospital of Sari, Mazandaran University of Medical Sciences
Street address
Amir-Mazandarani St.
City
Sari
Province
Mazandaran
Postal code
4816633131
Approval date
2019-12-25, 1398/10/04
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1398.147
Health conditions studied
1
Description of health condition studied
Seroma formation in breast cancer surgery
ICD-10 code
L76
ICD-10 code description
Intraoperative and postprocedural complications of skin and subcutaneous tissue
Primary outcomes
1
Description
Seroma formation
Timepoint
Days 3,7,14 after surgery
Method of measurement
Check the volume of secretions collected in the drain located at the site of operation
2
Description
Wound infection
Timepoint
Days 3,7,14 after surgery
Method of measurement
Wound observing and investigating the wound for local and systemic symptoms
3
Description
Wound opening
Timepoint
Days 3,7,14 after surgery
Method of measurement
Observing the wound
4
Description
Pain in wound
Timepoint
Days 3,7,14 after surgery
Method of measurement
Asking patient
5
Description
Limitation of mobility of limbs in site of wound
Timepoint
Days 3,7,14 after surgery
Method of measurement
Examination of patients' limb mobility
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group of breast mastectomy patients, after removing the flap, the flap will be connected to the pectoralis muscle in several rows using MONOCRYL suture (manufactured by SMI AG).
Category
Treatment - Surgery
2
Description
Control group: In this group of breast mastectomy patients, after removing the flap, the flap will be connected to the pectoralis muscle in several rows using conventional sutures.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Leyla Shojaee
Street address
Amir-Mazandarani
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
shojaeeleyla@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi
Street address
Moallem Sq.
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4000
Fax
+98 11 3335 2725
Email
publicrel@mazums.ac.ir
Grant name
Grant code / Reference number
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
60
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Leyla Shojaee
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
No. 19 Farah Abad St., Farah Abad Blvd., Khazar Square
City
Sari
Province
Mazandaran
Postal code
4818718477
Phone
+98 11 3326 4827
Email
shojaeeleyla@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Leyla Shojaee
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
No. 19 Farah Abad St., Farah Abad Blvd., Khazar Square
City
Sari
Province
Mazandaran
Postal code
4816978687
Phone
+98 11 3326 4827
Email
shojaeeleyla@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Leyla Shojaee
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
No 19. Farah Abad St., Farah Abad Blvd., Khazar Sq.
City
Sari
Province
Mazandaran
Postal code
4816978687
Phone
+98 11 3326 4827
Email
shojaeeleyla@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The data were read only to include unidentifiable individual profiles and main outcomes based on a reasonable request.
When the data will become available and for how long
The data will be available after publication.
To whom data/document is available
Researchers working in academic institutions and surgeons can access the data upon reasonable request.
Under which criteria data/document could be used
The data can be used for review and validation upon request.
From where data/document is obtainable
Dr. Leyla Shojaee, Imam Khomeini Hospital of Sari
What processes are involved for a request to access data/document
To request the data, an email stating the reasons will be sent to the person in charge of the clinical trial and after their approval, the data will be available.