Comparison of the Postoperative Results, and complications of Both-bone Forearm Fractures Surgery with or without suction Drainages in 15 to 65 y/o patients
Comparison of treatment results and complications after forearm fracture surgery with and without drainage
Design
نتایج درمانی گذاشتن درن یا عدم استفاده از آن در دو گروه که پس از انجام معیارهای ورود و خروج به صورت تصادفی انتخاب میگردند،مقایسه خواهد شد.
Settings and conduct
After confirmation of the fracture using AP and lateral radiography of the forearm, elbow and wrist, patients in the operating room will undergo volar henry approache to fix the radius bone and lateral approach to fix the ulna bone with screws and plates. After surgery In one group of patients, a hemovac drain will be inserted into the wound, and in the other group, the drain will be implanted after proper blood hemostasis. All surgeries will be performed by one certain surgeon and surgical assistant (study researchers) in the orthopedic operating room of Shahid Bahonar in Kerman
Participants/Inclusion and exclusion criteria
Inclusion criteria are patients aged 15 to 65 years old with closed fractures of the both bones of the forearm that require open reduction an internal fixation
Intervention groups
The therapeutic results of draining or not using it will be compared between the two groups.
Main outcome variables
In the two groups studied, the need for analgesia, infection, pain and bone union will be compared.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220619055220N1
Registration date:2022-06-30, 1401/04/09
Registration timing:prospective
Last update:2022-06-30, 1401/04/09
Update count:0
Registration date
2022-06-30, 1401/04/09
Registrant information
Name
Mohammadhadi Nateghi jahromi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5433 4568
Email address
hadi.nateghi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2023-07-23, 1402/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Postoperative Results, and complications of Both-bone Forearm Fractures Surgery with or without suction Drainages in 15 to 65 y/o patients
Public title
Comparison of the results of using a drain or not using it in forearm fractures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Fractures of the forearm bone between the ages of 15 and 65 that require open reduction and internal fixation
Exclusion criteria:
Open fractures as well as patients who have fractures in other organs
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of patients will be done using quadruple random blocks, considering that the number of treatment methods is two methods (randomly one method is called A and the other method B). Possible blocks are AABB, ABAB, ABBA, BAAB, BABA and BBAA are.These blocks are also randomly selected and assigned to each method based on the sequence created by the patients.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, blinding is performed on the data analyzer
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of kerman University of Medical Sciences
Street address
shahid bahonar hospital,kerman
City
kerman
Province
Kerman
Postal code
7613747181
Approval date
2022-06-18, 1401/03/28
Ethics committee reference number
IR.KMU.AH.REC.1401.052
Health conditions studied
1
Description of health condition studied
Forearm both bone fractures
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The rate of infection and union of the forearm bones.
Timepoint
During the first 48 hours, 2 weeks later, 6 weeks later, 3 months later and 6 months after surgery
Method of measurement
Patients' hemoglobin level before and after surgery using cbc test/Evaluation of patients' pain through visual analog score
Secondary outcomes
1
Description
Comparison of patients' pain during 48 hours after surgery/Comparison of hemoglobin loss in two groups/Comparison of patients' pain based on visual analog scale/Comparison of bone union in two groups.
Timepoint
During the first 48 hours, 2 weeks later, 6 weeks later, 3 months later and 6 months later.
Method of measurement
CBC-based hemoglobin measurement of patients/The amount of discharge from the hemovac drain
Intervention groups
1
Description
After confirmation of the fracture using AP and lateral radiographs of the forearm, elbow and wrist, patients in the operating room will undergo volar henry aproach to fix the radius bone and lateral approach to fix the ulna bone with screws and plates. After he surgery will be completed in one In one group of patients, a hemovac drain will be inserted into the wound, and in the other group,after complete hemostasis the drain will not be implanted. All surgeries will be performed by a surgeon and surgical assistant (study researchers) in one operating room.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
مرکز بیمارستانی شهید باهنر کرمان
Full name of responsible person
محمد هادی ناطقی جهرمی
Street address
shahid bahonar hospital,kerman
City
کرمان
Province
Kerman
Postal code
7613747181
Phone
+98 71 5433 4568
Email
hadi.nateghi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
mohammad hadi nateghi jahromi
Street address
shahid bahonar hospital,kerman
City
kerman
Province
Kerman
Postal code
7613747181
Phone
+98 71 5433 4568
Email
hadi.nateghi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
dramirreza sadeghifar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
shahid bahonar hospital,kerman
City
kerman
Province
Kerman
Postal code
7613747181
Phone
0098 32237115
Email
drsadeghifar2000@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
دکتر امیررضا صادقی فر
Position
دانشیار گروه ارتوپدی کرمان
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
shahid bahonar hospital,kerman
City
kerman
Province
Kerman
Postal code
7613747181
Phone
00 3432237115
Email
drsadeghifar2000@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
dramirreza sadeghifar
Position
associated professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
shahid bahonar hospital,kerman
City
kerman
Province
Kerman
Postal code
7613747181
Phone
0098 32237115
Email
drsadeghifar2000@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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All tests and measured patient variables will be available after the patients' personal information is not identifiable.
When the data will become available and for how long
After gathering complete and documented information
To whom data/document is available
For researchers in medical centers
Under which criteria data/document could be used
Requested data according to the approvals of the Medical Ethics Committee
From where data/document is obtainable
Medical ethics references of medical sciences
What processes are involved for a request to access data/document
Refer to Medical Ethics Center of Medical Sciences