Comparison of Surgical wound dehiscence and Infection rate in two Methods of Skin stapler and Nylon suture in Wound closure of Diabetic patients undergoing Total knee arthroplasty (TKA)
Investigating the rate of wound dehiscence and infection of surgical wound using two Methods of skin stapler and nylon thread in closing the wound of diabetic patients undergoing total knee replacement surgery
Design
Clinical trial, with control group, with parallel groups, without blinding, randomized on 120 patients. The participants will be randomly listed using computer software (RAS) into two groups of closure with nylon suture and closure with staples using permutation blocks in 15 blocks of 8.
Settings and conduct
The study will take place in the medical center of Lar city.
All diabetic patients undergoing total knee arthroplasty will be operated with the same techniques and tools. All patients will be operated from sub vestus approach and with PFC sigma depuy prosthesis by one surgeon.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
definitive diagnosis of diabetes through examination of tests; fasting blood sugar between 70 and 130;
Exclusion criteria:
History of cancer and chemotherapy, uncontrolled internal and vascular diseases;
Reduction of blood albumin;
Taking systemic corticosteroid drugs before surgery;
Having a history of knee surgery or the presence of scars and wounds in the knee area
Intervention groups
Intervention group: Using skin stapler to close the surgical wound;
Control group: using nylon suture to close the surgical wound
Main outcome variables
Wound infection, wound dehiscence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230928059543N1
Registration date:2024-01-12, 1402/10/22
Registration timing:prospective
Last update:2024-01-12, 1402/10/22
Update count:0
Registration date
2024-01-12, 1402/10/22
Registrant information
Name
Armin Fereidouni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3753 2383
Email address
arminfereidoni@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-01, 1402/12/11
Expected recruitment end date
2024-04-19, 1403/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Surgical wound dehiscence and Infection rate in two Methods of Skin stapler and Nylon suture in Wound closure of Diabetic patients undergoing Total knee arthroplasty (TKA)
Public title
Comparison of two wound closure methods after knee joint replacement in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Definitive diagnosis of diabetes through the examination of the patient's tests by an internal medicine specialist and the use of diabetes medications
presence of fasting blood sugar between 70 and 130 mg/dL
Age range from 40 to 90 years
Exclusion criteria:
History of cancer and chemotherapy, uncontrolled internal and vascular diseases
Reduction of blood albumin
Taking systemic corticosteroid drugs before surgery
Having a history of knee surgery or the presence of scars and wounds in the knee area
Getting infectious and viral diseases (colds and COVID-19) before and after surgery
Increased blood urea
Suffering from immunosuppressive diseases
Age
From 40 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be randomly assigned to two groups of closure with nylon suture and closure with staples using Random Allocation computer Software (RAS)version 4.9 (Internet address: https://random-allocation-software.software.informer.com/2.0/ ). Random allocation by the permutation block method is listed in 15 blocks of 8 with random allocation software, the list provided is attached to the proposal.
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 Shiraz University of Medical Sciences
Street address
5.7 side alley; 5 alley; Dolate-sharghy Blvd.; Shiraz
City
Shiraz
Province
Fars
Postal code
7167755954
Approval date
2023-11-11, 1402/08/20
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1402.112
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Wound infection
Timepoint
The evaluation of the results of the patient's wound in terms of the rate of wound infection will be followed up and recorded 2 to 8 weeks after the operation.
Method of measurement
Surgical wound infection checklist
2
Description
Wound dehiscence
Timepoint
The evaluation of the results of the patient's wound in terms of the rate of wound dehiscence will be followed up and recorded 2 to 8 weeks after the operation.
Method of measurement
Surgical wound dehiscence checklist
Secondary outcomes
empty
Intervention groups
1
Description
Control group: The first intervention group includes people who use nylon thread to close their wounds after knee replacement surgery. In the first group, surgical wound closure using 2-0 nylon thread (Supalon), monofilament with polyamide-6, which is produced by Supa company in Iran, will be done in a simple interrupted manner. Skin closure will be done at a 45-degree knee bend angle.
Category
Treatment - Surgery
2
Description
Intervention group: This group includes people whose wounds will be closed with skin staples after knee joint replacement surgery. In this group, surgical wound closure will be performed using a special covidin skin surgical stapler (Appose ULC 35W).
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Larestan Educational and Medical Center
Full name of responsible person
Armin Fereidouni
Street address
5.7 side alley; 5 alley; Dolate-sharghy Blvd.; Shiraz
City
شیراز
Province
Fars
Postal code
7167755954
Phone
+98 71 3753 2383
Email
arminfereidoni@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempur
Street address
5.7 side alley; 5 alley; Dolate-sharghy Blvd.; Shiraz
City
Shiraz
Province
Fars
Postal code
7167755954
Phone
+98 71 3753 2383
Email
arminfereidoni@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Armin Fereidouni
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
5.7 side alley; 5 alley; Dolate-sharghy Blvd.; Shiraz
City
Shiraz
Province
Fars
Postal code
7167755954
Phone
+98 71 3753 2383
Email
arminfereidoni@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Armin Fereidouni
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
5.7 side alley; 5 alley; Dolate-sharghy Blvd.; Shiraz
City
Shiraz
Province
Fars
Postal code
7167755954
Phone
+98 71 3753 2383
Email
arminfereidoni@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Armin Fereidouni
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
5.7 side alley; 5 alley; Dolate-sharghy Blvd.; Shiraz
City
Shiraz
Province
Fars
Postal code
7167755954
Phone
+98 71 3753 2383
Email
arminfereidoni@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
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 data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Study data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
By sending an email to the author responsible for the article, the data will be made available to experts in this field.
From where data/document is obtainable
People can get the study data by sending an email to Armin Feridouni (author responsible for the article).
Email: arminfereidoni@yahoo.com
What processes are involved for a request to access data/document
Ten days after receiving the email by the responsible author, the data will be available to the requesting person.