The results of this study will help orthopedic surgeons and other healthcare providers, including nurses, to use the most suitable suture method to reduce scars and pain after total knee replacement surgery and improve the quality of life of patients. The results of this study can also be extended to other surgical fields.
Design
The clinical trial has a control group with parallel groups, a crossover on 96 patients.
Settings and conduct
This is a single-blind clinical trial study that will be conducted in Hamedan Ba'ath Hospital in 1402. In this study, total knee joint replacement surgical skin suture with 4 methods of tandem polystitch nylon suture, modified buried vertical mattress suture of monocryl, vertical-horizontal mattress suture The modified nylon band and the surgical suture routine (subcuticular) will be performed in Baath Hospital. The participants will not have a total knee joint replacement in the process of using sutures.
Participants/Inclusion and exclusion criteria
• Adult patients (age ≥18 years)
• Having a signed informed consent form
• Patients who are candidates for total knee joint replacement
Intervention groups
The first group (exam): Tandem stitch group, poly stitch, nylon bank
The second group (examination): the suture group of the modified Bankh Monocryl vertical buried mattress
The third group (exam): modified vertical-horizontal mattress stitch group of nylon bankh
The fourth group (control): surgical suture group (subcuticular) in Baath Hospita
Main outcome variables
What is the average scar score of the patient and the satisfaction of the surgeon after the operation of total knee joint replacement with Tandem Suture Polystitch with Nylon, Modified Buried Vertical Mattress Suture, Modified vertical and horizontal mattress suture, Routine surgeon's suture (subcuticular)?
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230506058104N1
Registration date:2023-05-15, 1402/02/25
Registration timing:registered_while_recruiting
Last update:2023-05-15, 1402/02/25
Update count:0
Registration date
2023-05-15, 1402/02/25
Registrant information
Name
mina mirzaiee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3312 4683
Email address
m.mirzaiee@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-09, 1402/02/19
Expected recruitment end date
2023-08-10, 1402/05/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the results of using 3 suture techniques in total knee joint replacement surgeries
Public title
A comparative study of the results of using 3 suture techniques in total knee joint replacement surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patients (18 years or older)
Having a signed informed consent form
Patients who are candidates for total knee replacement
Exclusion criteria:
History of keloid scar formation
Long-term use of corticosteroids
Uncontrolled diabetes (Fasting blood sugar 200 mg/dL or more)
Previous knee surgery
Hypoalbuminemia Less than 5.3 mg/dL
Anemia (Hemoglobin less than 10 mg/dL)
Inflammatory joint disease (rheumatoid arthritis-psoriatic arthritis-bursitis...)
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
In the first step, the samples will be divided into smokers (at least one cigarette per day) and non-smokers using the stratified sampling method. Then we determine how many smoking participants and how many non-smoking participants will be placed in the 4 groups. In the next step, we will use the block method to divide this number of smoking and non-smoking participants into groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study will be single blind. In this way, the participants will not receive a total knee joint replacement in the process of using sutures.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی همدان
Street address
Hamedan, Shariati Crossroads, Ayatollah Kashani Boulevard, Hamedan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6517838697
Approval date
2023-05-04, 1402/02/14
Ethics committee reference number
IR.UMSHA.REC.1402.102
Health conditions studied
1
Description of health condition studied
total knee joint replacement surgerie
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Scar in patient and surgeon scar evaluation questionnaire
Timepoint
2 weeks-6 weeks-3 months
Method of measurement
Patient and surgeon scar evaluation questionnaire (PoSAS) - VAS surgeon satisfaction evaluation scale
Secondary outcomes
empty
Intervention groups
1
Description
The first group (exam): Tandem stitch group, poly stitch, nylon bankThe second group (examination): the suture group of the modified Bankh Monocryl vertical buried mattressThe third group (exam): modified vertical-horizontal mattress stitch group of nylon bankhThe fourth group (control): surgical suture group (subcuticular) in Baath Hospital
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
hospitals of Hamedan University of Medical Sciences
Full name of responsible person
Maryam madi neshat
Street address
Qaim Square, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
6517838697
Phone
+98 81 3838 0924
Email
medicalnashr@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokoohi
Street address
Qaim Square, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
6517838697
Phone
+98 81 3838 0924
Fax
Email
medicalnashr@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?