Comparison of the outcome of intra-medullary nailing surgery in femoral shaft fractures with and without wound washing.
Design
The study will be double blind and clinical trial.64 patients will be randomly divided into 2 groups. The groups are parallel. The trial phase is 3
Settings and conduct
Patients candidate for gintra-medullary nailing surgery in valiasr Hospital in Arak are divided into 2 groups by simple randomization with blocks.The study is double-blind in which outcome evaluator and data analyst and participant are kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Non-pathological femoral shaft fracture, age 15 to 65 years,
lack of underlying disease such as diabetes and hypertension, both gender
Exclusion criteria:no follow-up, death
Intervention groups
Intervention group: In this group, all the conditions of fullness and observation are observed first, and after the surgery of the operation area (muscles and bones), normal saline solution is washed in three layers of fascia and skin of the minister without washing.
Control group : In this group, first all the conditions are observed, but unlike the previous group, after surgery and before closing the wound, the operation area will be completely cleansed with about one liter of normal saline solution.
Main outcome variables
Wound healing, fracture healing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211207053318N1
Registration date:2021-12-19, 1400/09/28
Registration timing:prospective
Last update:2021-12-19, 1400/09/28
Update count:0
Registration date
2021-12-19, 1400/09/28
Registrant information
Name
Aliasghar Alimadadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8899 6286
Email address
d.a.alimadadi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-02, 1400/10/12
Expected recruitment end date
2022-04-01, 1401/01/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the outcome of intra-medullary nailing surgery in femoral shaft fractures with and without wound washing
Public title
outcome of intra-medullary nailing surgery in femoral shaft fractures with and without wound washing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Non-pathological femoral shaft fracture
age 15 to 65 years
lack of underlying disease such as diabetes and hypertension
Both gender
Exclusion criteria:
No follow-up
Death
Age
From 15 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated into 2 groups using a permuted balanced block randomization method with the size of blocks 4 and 8. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients as well as the project data analyzer and the project assistant who is responsible for completing the questionnaires will be unaware of the division of patients into two groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2021-11-14, 1400/08/23
Ethics committee reference number
IR.ARAKMU.REC.1400.224
Health conditions studied
1
Description of health condition studied
Femoral shaft fractures
ICD-10 code
S72.0
ICD-10 code description
Fracture of neck of femur
Primary outcomes
1
Description
Improving fracture location
Timepoint
6 weeks, 3, 4 and 6 months after surgery
Method of measurement
Radiology examination
2
Description
Wound healing
Timepoint
2, 4 and 11 days after surgery
Method of measurement
Physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In this group, all the conditions of fullness and observation are observed first, and after the surgery of the operation area (muscles and bones), normal saline solution is washed in three layers of fascia and skin of the minister without washing.
Category
Treatment - Surgery
2
Description
Control group : In this group, first all the conditions are observed, but unlike the previous group, after surgery and before closing the wound, the operation area will be completely cleansed with about one liter of normal saline solution.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr. Mohsen Parsi Khameneh
Street address
Valiasr hospital, Valiasr squre
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
d.a.alimadadi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Street address
Valiasr hospital, Valiasr squre
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3645
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohsen Parsi Khameneh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
d.a.alimadadi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr.Aliasghar Alimadadi
Position
Resident of Orthopedi
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
d.a.aalimadadi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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