The efficacy of face-to-face training with a surgeon versus virtual instruction on the outcome of reverse sural flap surgery
Design
This clinical trial will be done on 20 patients (one intervention group consists of 10 patients and the control group is parallel to 10 patients). Randomization is done by the blocking randomization method.
Settings and conduct
Patients with extensive lower limb injuries referred to Shohada Tajrish Hospital in Tehran candidates for reverse sural flap will be randomly assigned to two groups of control and intervention. blinding is not performed in this study.
Participants/Inclusion and exclusion criteria
Patients above 18 years with extensive lower limb injury, candidates for reverse sural flap surgery will be included in the study, and patients with lower limb injuries concurrent with neurovascular injuries for whom flap surgery is not possible will be excluded.
Intervention groups
Patients in the intervention group were trained in face to face before flap surgery, but in the intervention group patients were shown short videos.
Main outcome variables
The postoperative volume of bleeding, the rate of infection and wound problems of the patient, and the amount of flap congestion will be assessed
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211201053235N5
Registration date:2022-06-18, 1401/03/28
Registration timing:prospective
Last update:2022-06-18, 1401/03/28
Update count:0
Registration date
2022-06-18, 1401/03/28
Registrant information
Name
Meisam Jafari Kafiabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8000
Email address
dr.jafari8567@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of face-to-face training with a surgeon versus virtual instruction on the outcome of reverse sural flap surgery
Public title
The efficacy of virtual instruction on the outcome of reverse sural flap surgery
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients above 18 years
extensive lower limb injury candidate for reverse flap surgery
patients with lower limb injuries whose vessels are intact
distal arterial-arterial connections are patent
Exclusion criteria:
Patients with vascular injuries of the lower extremities whose blood flow is impaired
Patients with neural injuries of lower extremities
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Shahid Beheshti University of Medical Sciences
Street address
Shahrdari Street, Tajrish Square
City
tehran
Province
Tehran
Postal code
198353-5511
Approval date
2022-03-13, 1400/12/22
Ethics committee reference number
IR.SBMU.RETECH.REC.1400.1195
Health conditions studied
1
Description of health condition studied
Crushing injury of lower leg
ICD-10 code
S87
ICD-10 code description
Crushing injury of lower leg
Primary outcomes
1
Description
The rate of infection after surgery
Timepoint
At 2 weeks, 4 weeks, 6 weeks, 8 weeks, 3 months and 6 months after surgery
Method of measurement
Examination of wounds for infection
2
Description
Flap congestion after surgery
Timepoint
At 2 weeks, 4 weeks, 6 weeks, 8 weeks, 3 months and 6 months after surgery
Method of measurement
Physical examination and observation of wound by surgeon
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Fifteen patients with severe lower limb injuries who are candidates for reverse sural flap surgery, the video is shown to them several times before surgery, and before surgery, we make sure that the patient sees and understands the video.
Category
Rehabilitation
2
Description
Control group: In the control group, the surgeon explains to the patient face to face. The other pre-and post-operative consideration is similar and all surgeries are performed by one surgeon.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Tajrish Hospital
Full name of responsible person
Meisam Jafari Kafiabadi
Street address
Tajrish Square, Shahrdari Street
City
tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
pr_shohada@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Tajrish Square, Shahrdari Street
City
tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Email
intl_office@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Farsad Biglari
Position
Assistant professor
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Shahrdari Street, Tajrish Square
City
tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
pr_shohada@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Meisam Jafari Kafiabadi
Position
Assistant professor
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Shahrdari Street, Tajrish Square
City
tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
dr.jafari8567@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Meisam Jafari Kafiabadi
Position
Assistant professor
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Shahrdari Street, Tajrish Square
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
dr.jafari8567@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
Participants' data file, study protocol, statistical analysis map, informed consent form and clinical study report will all be fully shareable after disclosing personal information.
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
The information will be available to anyone who requests access
Under which criteria data/document could be used
The information will be available to anyone who requests access
From where data/document is obtainable
Meisam Jafari Kafiabadi, Email:dr.jafari8567@yahoo.com, Address: School of Medicine ,Shahid Beheshti University of Medical Sciences, Yemen St., Shahid Chamran Highway, Tehran ,Iran Postal Code: 1985717443
What processes are involved for a request to access data/document
After sending the request for access to information and specifying the type of requested information to the email of the person in charge of correspondence, they will prepare the requested information and send it to the applicant.