Evaluation of the effect of using a special waterproof layer under the tourniquet cuff on the burn incidence and pain intensity after surgery in the patient and the level of satisfaction of operating room staff in knee arthroscopic surgeries
Determining the effect of the use of a special tourniquet on the incidence of burns and the severity of pain after the operation of the patient and the satisfaction level of the operating room personnel
Design
The clinical trial has a control group, with a parallel group, a blind strain of the statistical analyzer, phase 2 on 34 patients. Simple random method
Settings and conduct
This study is conducted in the form of a randomized clinical trial study of a blinded statistical analyst; This means that the statistical analyzer will remain unaware of the division of groups and groups of each patient. The place of research is Isfahan University of Medical Sciences. study groups:
Even days: Using a special waterproof drip under the tourniquet cuff: a tourniquet will be used under which a special tourniquet will be used.
Odd days: an inflatable tourniquet is used under which four layers of vibril made of 100% cotton are used.
Participants/Inclusion and exclusion criteria
Entry conditions: arthroscopic knee surgery with the need to use a tourniquet.
The condition of non-entry: the surgery is an emergency
Intervention groups
Sampling intervention group on even days: using a special waterproof drape under the tourniquet cuff: the tourniquet used is an inflatable type, under which a special tourniquet drape will be used to protect the skin. Odd days sampling control group: using the usual layers under the tourniquet cuff: the tourniquet used is an inflatable tourniquet with four vibril layers made of 100% pure cotton under it. It will be used to protect the skin.
Main outcome variables
Patient's pain after surgery in the place of tourniquet cuff
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220718055487N1
Registration date:2022-07-26, 1401/05/04
Registration timing:prospective
Last update:2022-07-26, 1401/05/04
Update count:0
Registration date
2022-07-26, 1401/05/04
Registrant information
Name
Nafise Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4425 4561
Email address
nafiserahimi7@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-19, 1401/05/28
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of using a special waterproof layer under the tourniquet cuff on the burn incidence and pain intensity after surgery in the patient and the level of satisfaction of operating room staff in knee arthroscopic surgeries
Public title
Evaluation of the effect of using a special waterproof layer under the tourniquet cuff on the burn incidence and pain intensity after surgery
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 and over
Informed consent to participate in the study
Arthroscopic knee surgery with the need to use a tourniquet
The surgery is not an emergency
Absence of fractures in other body organs based on the information in the patient's file
No history of cardiovascular diseases such as congestive heart failure, cardiac arrhythmias, high blood pressure, diabetes based on patient file information
Non-use of drugs or continuous use of alcohol or cigarettes more than 5 packs per year based on the person's self-report
The absence of trauma to the chest, head or abdomen based on the person's self-report
No need for other surgeries, in addition to orthopedic surgery, based on the patient's file information
Absence of coagulation diseases or the need to take anti-coagulation drugs based on the person's medical and medical history
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: simple
In this study, considering that the distribution of patients will be done by the day of surgery (patients on even and odd days), therefore, there is no tool for randomization.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is conducted in the form of a randomized clinical trial study of a blinded statistical analyst; This means that the statistical analyzer will remain unaware of the division of groups and groups of each patient.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Isfahan University of Medical Sciences - Al-Zahra Research Center
Street address
No.10, mojgan alley, east yeganeh alley, bahar ave, marzdaran blv, tehran
City
Tehran
Province
Tehran
Postal code
1461844371
Approval date
2022-07-09, 1401/04/18
Ethics committee reference number
IR.ARI.MUI.REC.1401.115
Health conditions studied
1
Description of health condition studied
Burns of the patient after surgery caused by the use of monopolar cautery - pain after surgery of the patient at the place of closure of the tourniquet
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Patients who suffer from monopolar cautery burns after surgery
Timepoint
Before surgery, immediately after surgery
Method of measurement
Direct observation by the student and completion of the relevant checklist
2
Description
Pain after surgery of patients in the place of tourniquet
Timepoint
Immediately after surgery, up to 24 hours after the patient enters recovery (every 8 hours)
Method of measurement
Visual analogue scale
3
Description
Personnel satisfaction with the waterproof tourniquet cover
Timepoint
Immediately after the intervention
Method of measurement
Satisfaction questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Using a special waterproof drip under the tourniquet cuff (17 people): After preparing the patient and inducing anesthesia, an inflatable tourniquet is used under which a special tourniquet drape will be used to protect the skin.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital, Isfahan
Full name of responsible person
Soheila bakhtiari
Street address
No. 35, tabatabaei alley, kamal esmaeil ave, isfahan
City
Isfahan
Province
Isfehan
Postal code
1461844371
Phone
+98 913 302 2733
Email
bakhtiari@nm.mui.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shiva mortazavi
Street address
Research and Technology Vice-Chancellor, building No 4, Sciences and Health Care Services, Isfahan University of Medical,Hazar Jarib St.isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Nafise rahimi
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Operating room expert
Street address
No.10,mojgan alley, east yeganeh alley, bahar ave, marzdaran blv, tehran
City
Tehran
Province
Tehran
Postal code
1461844371
Phone
+98 21 4425 4561
Email
Nafiserahimi7@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nafise rahimi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Operating room expert
Street address
No.10, mojgan alley, east yeganeh alley, bahar ave, marzdaran blv, tehran
City
Tehran
Province
Tehran
Postal code
1461844378
Phone
+98 21 4425 4561
Email
Nafiserahimi7@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nafise rahimi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Operating room expert
Street address
No.10, mojgan alley, east yeganeh alley, bahar ave, marzdaran blv , tehran
City
Tehran
Province
Tehran
Postal code
1461844361
Phone
+98 21 4425 4561
Fax
Email
Nafiserahimi7@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
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The report of the results of the personnel satisfaction questionnaire for the use of a special tourniquet and the report of the results of the checklist for burns and pain after surgery in patients.
When the data will become available and for how long
Access starts 6 months after the results are published
To whom data/document is available
Researchers affiliated with universities and scientific institutions
Under which criteria data/document could be used
The results of the data in order to find new solutions to reduce complications caused by the use of tourniquets
From where data/document is obtainable
Nafise Rahimi
Telephone Number : 00989059856560
Email: Nafiserahimi7@gmail.com
Address: No.10, mojgan alley, east yeganeh alley, bahar ave, marzdaran blv, tehran
What processes are involved for a request to access data/document
Email the identification card related to the scientific institute or university to Nafiserahimi7@gmail.com.