The Comparison of the Incidence and Severity of Wound Infection to 2 Methods of Primary Prep Washing with 70% Alcohol and Normal Saline in Patients Undergoing Orthopedic Surgery
The purpose of this study is to compare the incidence and severity of wound infection with two methods of washing the primary orthopedic prep area with 70% alcohol and normal saline.
Design
This is a three-way blind randomized clinical trial by block method with parallel intervention and control groups on 190 patients.
Settings and conduct
This study will be conducted in Kowsar Sanandaj Hospital in Iran. At first, patients who meet the inclusion criteria are purposefully included in the study; Then they will be randomly assigned to two intervention and control groups in the form of double blocks. The method of blinding the study is three-blind. The participants, the second researcher as the outcome assessor and data analyst will be unaware of the type of intervention.
Participants/Inclusion and exclusion criteria
Participants will be included in the study based on the following criteria. Elective orthopedic surgery volunteer of the upper limb; volunteer to participate in research; Shaving hair before surgery; The patient's body mass index is less than 30; lack of skin damage in the surgical area due to trauma; Absence of underlying, infectious diseases; Immune system disorders, skin allergies; Burns and previous surgery in the prep area and no vascular problems in the organ under surgery
Intervention groups
In both intervention and control groups, the surgical site will be prepped with brown betadine diluted with normal saline for three minutes. Then, in the intervention group, the primary prep area is washed with 70% alcohol and in the control group with normal saline.
Main outcome variables
The severity of wound infection in the two groups will be measured based on the comparison of the average score obtained from the standard Assepsis index tool up to two weeks after the patient's discharge from the hospital. A score lower than 10 means no wound infection.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160301026861N3
Registration date:2023-04-24, 1402/02/04
Registration timing:retrospective
Last update:2023-04-24, 1402/02/04
Update count:0
Registration date
2023-04-24, 1402/02/04
Registrant information
Name
Jamal Seidi
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 3182 7464
Email address
jamal.seidi@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-08, 1399/01/20
Expected recruitment end date
2022-10-12, 1401/07/20
Actual recruitment start date
2020-04-08, 1399/01/20
Actual recruitment end date
2023-03-11, 1401/12/20
Trial completion date
2023-03-11, 1401/12/20
Scientific title
The Comparison of the Incidence and Severity of Wound Infection to 2 Methods of Primary Prep Washing with 70% Alcohol and Normal Saline in Patients Undergoing Orthopedic Surgery
Public title
Comparison of the effect of two methods of primary washing of the area disinfected with brown betadine with 70% alcohol and normal saline on the incidence and severity of postoperative wound infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient is a volunteer for elective orthopedic surgery of the upper limb
The patient is a volunteer to participate in the research
The hair in the surgical area must be shaved before the operation
The body mass index of the patient is less than 30
Exclusion criteria:
There should be no skin damage in the surgical area due to trauma
The patient does not have any underlying diseases or skin allergies
The patient does not have burns or previous surgery in the prep area
The patient does not have vascular problems in the organ under surgery
The patient does not have diseases related to the immune system and infectious diseases
The patient does not have digestive or blood diseases
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
190
Actual sample size reached:
190
Randomization (investigator's opinion)
Randomized
Randomization description
At the beginning of the study and based on the entry criteria, patients who meet the conditions for entry into the study are entered into the study. Then, considering the importance of random assignment in clinical trial studies to control possible confounders, the samples are randomly assigned to each of the intervention or control groups in the form of a double block.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The method of blinding the study is three-blind. Patients undergoing orthopedic surgery as research samples will not know the type of intervention. Before the study, from an ethical point of view, the samples will be informed that one of two types of intervention may be done for them, and written consent will be obtained from them. The first researcher in the intervention and control group performs the necessary interventions. The second researcher measures the incidence and severity of wound infection after surgery without knowing the type of intervention and the groups; Therefore, as a second person, he will be blind to the study. Also, the statistical consultant as a data analyst will be unaware of the groups; therefore, he will be considered as the third person blinded to the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kurdistan University of Medical Sciences
Street address
Pasdaran Blvd; Faculty of Nursing and Midwifery; Kurdistan University of Medical Sciences, Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Approval date
2019-12-24, 1398/10/03
Ethics committee reference number
IR.MUK.REC.1398.222
Health conditions studied
1
Description of health condition studied
Primary prep area of patients candidates for elective orthopedic surgery of the upper limbs
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The incidence of wound infection after surgery with a score higher than ten from the wound evaluation and the absence of wound infection with a score lower than 10 will be measured by the ASEPSIS INDEX tool after orthopedic surgery.
Timepoint
It will be measured once. The symptoms of wound infection will be monitored from the time after surgery until two weeks after discharge from the hospital, and on the 14th day after discharge, the scores obtained from the Asepsis index tool will be collected.
Method of measurement
Based on the ASEPSIS INDEX tool, evaluation of wound healing after surgery including; Complementary antibiotic therapy (0-10 points), redness of the wound at the surgical site (0-5 points), serous discharge from the surgical site (0-5 points), deep disintegration of the wound (0-10 points), culture from the wound site and isolation of bacteria ( 0-10 points) Wound debridement under general anesthesia (0-10 points), drainage of purulent wound secretions under local anesthesia, purulent exudate (0-10 points), hospitalization for more than 14 days (0-5 points). The maximum score will be 70 and the minimum score will be zero. A score less than ten means complete healing of the wound and no wound infection. A score higher than ten means wound infection.
2
Description
The severity of wound infection after surgery will be determined based on the ASEPSIS INDEX standard tool. Based on this tool, a score of 0-10 indicates complete healing of the wound, a score of 11-20 indicates impaired wound healing, a score of 21-30 indicates partial wound infection, a score of 31-40 indicates moderate wound infection, and a score greater than 40 indicates severe wound infection.
Timepoint
It will be measured once. The symptoms of wound infection will be monitored from the time after surgery until two weeks after discharge from the hospital, and on the 14th day after discharge, the scores obtained from the Asepsis index tool will be collected.
Method of measurement
In this study, the average scores obtained from the ASEPSIS INDEX standard tool will be compared in two intervention and control groups.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The surgical site must be completely shaved. The surgical area will be prepped with 5.7% betadine brown diluted with normal saline for three minutes. After the initial prep, betadine will be brown on the skin surface for two minutes. Then the surgical site is washed with 70% alcohol until the skin surface is free of betadine. Wait until the alcohol dries on the surface of the skin. After the intervention, secondary prep will be done with betadine 10% and with the help of three gauzes and for at least five minutes.
Category
Treatment - Surgery
2
Description
Control group: the surgical site must be completely shaved. The surgical area will be prepped with 7.5%brown betadine diluted with normal saline for three minutes. After the initial prep, brown will be on the skin surface for two minutes. Then, the surgical site is washed with normal saline until the skin surface is free of betadine. Then, using a sterile towel, the primary prep area will be dried. . After washing or normal saline serum and drying, secondary prep of the surgical area will be done again with betadine 10% and with the help of three gauzes and for at least five minutes.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital affiliated to Kurdistan University of Medical Sciences
Full name of responsible person
Behzad Gholamveisi
Street address
Pasdaran Blvd; School of Nursing and Midwifery; Kurdistan University of Medical Sciences; Sanandaj; Iran
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 0095
Email
behzad.gholamveisi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Afshin Maleki
Street address
Pasdaran Blvd; Deputy of research and technology; Kurdistan University of Medical Sciences; Sanandaj; Iran
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4654
Fax
+98 87 3366 4643
Email
Research@muk.ac.ir
Web page address
https://research.muk.ac.ir/Page?pageId=60
Grant name
Research project contract with Kurdistan University of Medical Sciences No. 222/1398 in the amount of twenty one million Rials
Grant code / Reference number
1805003000
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Jamal Seidi
Position
Associate Professor of Nursing and Director of Operating Room Department of Kurdistan University of
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Pasdaran Blvd; Faculty of Nursing and Midwifery, Kurdistan University of Medical Sciences, Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 0095
Fax
+98 87 3366 0095
Email
jamal.seidi@muk.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Jamal Seidi
Position
Associate Professor of Nursing and Director of Operating Room Department of Kurdistan University of
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Pasdaran Blvd; Faculty of Nursing and Midwifery, Kurdistan University of Medical Sciences, Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 0095
Email
jamal.seidi@muk.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Jamal Seidi
Position
Associate Professor of Nursing and Director of Operating Room Department of Kurdistan University of
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Pasdaran Blvd; Faculty of Nursing and Midwifery, Kurdistan University of Medical Sciences, Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 0095
Email
jamal.seidi@muk.ac.ir
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
Results of data analysis
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
For use in meta-analysis, systematic review and compilation of clinical guidelines
From where data/document is obtainable
Jamal Seidi
Bs, MSc, PhD .Nursing
Associate Professor of Nursing and Midwifery Faculty. Kurdistan University of medical sciences, Sanandaj, Iran
Email : jamal.seidi@yahoo.com
Jamal.seidi@muk.ac.ir
mobile:+98-918-378-1006
What processes are involved for a request to access data/document
Written and valid request by e-mail jamal.seidi@yahoo.com