Protocol summary

Study aim
Comparing the clinical effects of using nylon tape to close the sternum after sternotomy instead of wire.
Design
Clinical trial with control group, with parallel group, without blinding, randomized ,. The process of random allocation will be done using envelopes in such a way that an equal number of types of treatment groups are written inside the envelopes, and when each patient visits, the doctor chooses one of the envelopes and considers the type of treatment group written in the envelope for the individual.
Settings and conduct
This study will be done in bojnurd city. Based on each person's visit to the hospital, people will be included in the study until the required sample size is met. Patients are randomly divided into two groups. In one group, nylon tape is used to close the sternum after median sternotomy, and in the other group, the usual method of using wire is used in surgery. The process of random allocation will be done using envelopes in such a way that an equal number of types of treatment groups are written inside the envelopes, and when each patient visits, the doctor chooses one of the envelopes and considers the type of treatment group written in the envelope for the individual. Both groups are followed up for 6 months and the studied variables are measured at 1 month, 3 months and 6 months after the operation.
Participants/Inclusion and exclusion criteria
Patients who undergo median sternotomy are included in the study, and patients weighing more than 90 kg and patients with osteoporosis excluded from the study.
Intervention groups
In one group, nylon tape is used to close the sternum after median sternotomy, and in the other group, the usual method of using wire is used in surgery
Main outcome variables
Infection after the operation, Duration of sternal closure, Stability of the sternum, The amount of bleeding after the operation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230805059050N1
Registration date: 2024-08-07, 1403/05/17
Registration timing: prospective

Last update: 2024-08-07, 1403/05/17
Update count: 0
Registration date
2024-08-07, 1403/05/17
Registrant information
Name
Keivan Sobhanian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3151 4252
Email address
keivansobhanian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2025-03-20, 1403/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A new proposed method for sternal closure using a nylon tape
Public title
method of sternal closure using a nylon tape
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who undergo heart surgery
Exclusion criteria:
Patients over 90 kg Patients with osteoporosis
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 110
Randomization (investigator's opinion)
Randomized
Randomization description
The process of random allocation will be done using envelopes in such a way that an equal number of types of treatment groups are written inside the envelopes, and when each patient visits, the doctor chooses one of the envelopes and considers the type of treatment group written in the envelope for the individual.
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
Ethics Committee of North Khorasan University of Medical Sciences
Street address
Arkan Road ,Imam Hassan educational, research and treatment center ,Heart department
City
Bojnurd
Province
North Khorasan
Postal code
945315174
Approval date
2024-06-22, 1403/04/02
Ethics committee reference number
IR.NKUMS.REC.1403.049

Health conditions studied

1

Description of health condition studied
sternal closure
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Postoperative infection (superficial and deep)
Timepoint
1 month after the operation
Method of measurement
Diagnosis of infection through clinical observation and WBC count

Secondary outcomes

1

Description
Pain
Timepoint
After operation
Method of measurement
It is measured using the Visual Analogue Scale (VAS) questionnaire.

2

Description
Functional Independence
Timepoint
Before and after operation
Method of measurement
Using the Functional Independence Measure (FIM) questionnaire, we measure the individual's independent functioning before and after surgery and calculate its percentage.

3

Description
Amount of bleeding after the operation
Timepoint
After the operation
Method of measurement
Measuring drain secretions

4

Description
Stability of the Sternum
Timepoint
Visits after surgery
Method of measurement
Physical examination

5

Description
Duration of closing the sternum during the operation
Timepoint
During the operation
Method of measurement
Measuring the time interval of sternum closure

Intervention groups

1

Description
Intervention group: nylon tape is used to close the sternum after Median sternotomy
Category
Treatment - Surgery

2

Description
Control group: The conventinal method of using a wire is used to close the sternum.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Cardiology Department of Imam Hassan Hospital of Bojnourd
Full name of responsible person
Keivan Sobhanian
Street address
Arkan Road, Imam Hassan Hospital , Cardiology Department
City
Bojnourd
Province
North Khorasan
Postal code
945315174
Phone
+98 912 635 4803
Email
keivansobhanian@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
DR. BIBAK
Street address
DANESHGHAH AVE , Research Vice-Chancellor
City
Bojnurd
Province
North Khorasan
Postal code
74877-94149
Phone
+98 58 3151 1423
Email
keivansobhanian@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd University of Medical Sciences
Proportion provided by this source
100
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
Bojnourd University of Medical Sciences
Full name of responsible person
Keivan Sobhanian
Position
Associate Professor, cardiac Surgeon
Latest degree
Subspecialist
Other areas of specialty/work
Cardiac surgery
Street address
Arkan Road ,Imam Hassan Educational, Research and Treatment Center ,Heart Department
City
Bojnourd
Province
North Khorasan
Postal code
945315174
Phone
+98 51 3151 4252
Email
keivansobhanian@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Keivan Sobhanian
Position
Associate Professor , Cardiac surgeon
Latest degree
Subspecialist
Other areas of specialty/work
Cardiac surgery
Street address
Arkan Road, Imam Hassan Hospital , Cardiology Department
City
Bojnourd
Province
North Khorasan
Postal code
945315174
Phone
+98 51 3151 4252
Email
keivansobhanian@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Negin Armide
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Arkan Road, Imam Hassan Hospital
City
Bojnourd
Province
North Khorasan
Postal code
945315174
Phone
+98 51 3151 4252
Email
negin.armide@gmail.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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The research results can be shared.
When the data will become available and for how long
The access period starts after the results are reported
To whom data/document is available
just for researchers
Under which criteria data/document could be used
no condition required
From where data/document is obtainable
to the email inserted
What processes are involved for a request to access data/document
almost one week
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