1. Comparison of surgical knife incision wound with electrocautery in operated patients
2. Determining the amount of postoperative pain in surgical incision with a scalpel
3. Determining the amount of postoperative pain in surgical incision with electrocautery
4. Determining the healing time of the surgical scar after surgical incision with a scalpel
5. Determining the healing time of the surgical scar after surgical incision with an electrocautery
6. Determining the amount of bleeding following surgical incision with a scalpel
7. Determining the amount of bleeding following surgical incision with electrocautery
8. Determining the extent of infection after surgery with a scalpel
9. Determining the rate of infection after electrocautery surgery
Design
A clinical trial with 3 parallel groups to evaluate the results of randomized wound healing on 90 patients. R software was used for randomization.
The R Project for Statistical Computing
https://www.r-project.org/
Settings and conduct
This study will be performed in Taleghani Hospital. Patients will be randomly divided into three equal groups. In one group, patients will be operated on with a knife, in the second group with an electrocautery and in the third group with a combined incision of a knife and an electrocautery. Wound complications will be evaluated at postoperative visits
Participants/Inclusion and exclusion criteria
Patients older than 18 years with a fracture who have the ability to follow up and evaluate the results for at least a specified period of time.
Intervention groups
1- Knife group
2- Electrocauter group
3- Combination therapy group of knife and electrocautery
Main outcome variables
1. Duration of surgical scar healing
2. The amount of bleeding following a surgical incision
3. The rate of infection after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180306038971N2
Registration date:2020-09-30, 1399/07/09
Registration timing:registered_while_recruiting
Last update:2020-09-30, 1399/07/09
Update count:0
Registration date
2020-09-30, 1399/07/09
Registrant information
Name
Mohammad Ali Okhovatpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 2222
Email address
okhovatpour@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-10, 1399/06/20
Expected recruitment end date
2020-10-11, 1399/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between knife and electrocautery incisions in extremity's surgery
Public title
Comparison between knife and electrocautery incisions in extremity's surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who referred to orthopedic surgery in extremity's
Exclusion criteria:
Orthopedic surgery in extremities
No blister necrosis infection and serious tissue damage at the incision site
No active systemic infection
No blood coagulation problems
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization for 3 intervention groups. The randomization method will done using software, 30 random numbers for each intervention group.
The researcher can not play a role in predicting treatment of the disease, and choosing the type of treatment. random sequence will generate by software. Group 1: 30 Cases and Groups 2 :30 & 3: 30 cases.
Software: random allocation
website: https://random-allocation-software.software.informer.com/2.0/
Data: 90 codes for 90 patients (30 patients for each group)
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients have dressings to compare the results of each treatment after surgery and are evaluated by an orthopedist who has no knowledge of the treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Ethics and Law Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Street address
Chamran highway, Yaman st, Arabi st, next to Taleghani hospital
City
Tehran
Province
Tehran
Postal code
1985717434
Approval date
2017-11-27, 1396/09/06
Ethics committee reference number
IR.SBMU.RETECH.REC.1396.419
Health conditions studied
1
Description of health condition studied
Wound complications due to surgical incision
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Bleeding during surgery
Timepoint
After 24 hours, 1 weeks, 2 weeks and 4 weeks
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Infection
Timepoint
After 24 hours, 1 weeks, 2 weeks and 4 weeks
Method of measurement
Wound examination
2
Description
Surgical scar
Timepoint
After surgery
Method of measurement
Surgical ruler
Intervention groups
1
Description
Patients who are cut with a knife
Category
Treatment - Surgery
2
Description
Patients undergoing electrocautery incision
Category
Treatment - Surgery
3
Description
Patients undergoing knife and electrocautery incision
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان آیت الله طالقانی
Full name of responsible person
محمد علی اخوت پور
Street address
Next to Shahid Beheshti University of Medical Sciences, Yemen St., Arabi St., Chamran highway.
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1294
Fax
+98 21 2303 1294
Email
okhovatpour@sbmu.ac.ir
Web page address
https://taleghani.sbmu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
معاونت تحقیقات و فناوری دانشگاه علوم پزشکی شهید بهشتی
Street address
Shahid Beheshti University of Medical Sciences, Yemen St., Arabi St., Chamran highway.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Fax
+98 21 2243 9781
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Ali Okhovatpour
Position
استادیار
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Taleghani hospital, next to Shahid Beheshti University of Medical Sciences, Yemen St., Arabi St., Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1294
Email
okhovatpour@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Ali Okhovatpour
Position
استادیار
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Taleghani hospital, next to Shahid Beheshti University of Medical Sciences, Yemen St., Arabi St., Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1294
Email
okhovatpour@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Ali Okhovatpour
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Taleghani hospital, next to Shahid Beheshti University of Medical Sciences, Yemen St., Arabi St., Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1294
Email
okhovatpour@sbmu.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
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data can be shared potentially after patients became unrecognizable.
When the data will become available and for how long
After completing the results and analyzing the data, access to them is allowed.
To whom data/document is available
This is only available for people working in academic institutions
Under which criteria data/document could be used
After obtaining written permission, the use of the data is permitted with reference to the source.
From where data/document is obtainable
Orthopedic ward in Taleghani hospital, next to Shahid Beheshti University of Medical Sciences, Yemen St., Arabi St., Chamran Highway. Tell: 00982123031216 Mohammad Ali Okhovat Pour Tell:00982123031294 e-mail: okhovatpour@gmail.com Yaser Safaei Tell:00989155113937 e-mail: yasersafa@yahoo.com
What processes are involved for a request to access data/document
After completing the results and analyzing the data, the use of the data is allowed after the written request.