The purpose of this study was to compare the results of the control group with the group of simultaneous wound transplantation in patients with grade 1, 2 and 3 burns and patients with diabetic foot ulcer and trauma less than 5 cm wide.
Design
A clinical trial with a community-based, pragmatic control group with parallel, randomized groups
Settings and conduct
Patients from Skin Research Center of Shahid Beheshti University will candidate by dermatologist. Lesion of skin will dress and progress by 14 days will be control by expert.
Participants/Inclusion and exclusion criteria
Including criteria:
Skin lesions due to Trauma, Burn, and Cancer
Excluding criteria:
Patients with autoimmune diseases
Patients with skin diseases
Patients with skin related infectious diseases
Intervention groups
Intervention 1: Wound healing with dead tissue removal and early transplantation with autologous PRGF gel and evaluation until day 14 post-transplantation.
Intervention 2: Control group, with conventional treatment.
In both groups, open the dressing on the fifth day after surgery, the wound was washed with normal saline and covered with sterile Vaseline gas and re-dressed. Changing the dressing will continue for one day until the transplant is complete.
Main outcome variables
Repaired wound
General information
Reason for update
Acronym
SLR
IRCT registration information
IRCT registration number:IRCT20190826044620N1
Registration date:2020-01-18, 1398/10/28
Registration timing:prospective
Last update:2020-01-18, 1398/10/28
Update count:0
Registration date
2020-01-18, 1398/10/28
Registrant information
Name
Mostafa Rezaei Tavirani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 9787
Email address
tavirani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bio-compatible wound dressing for repairing skin lesions: Trauma, Burn, and Cancer: A Clinical Trial
Public title
Repairing skin lesions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Skin lesions due to Trauma, Burn,
Exclusion criteria:
Autoimmune diseases
Skin diseases
Skin related infectious diseases
Age
From 18 years old to 55 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
6
Randomization (investigator's opinion)
N/A
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
Arabi Ave, Daneshjoo Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
19839-63113
Approval date
2019-07-21, 1398/04/30
Ethics committee reference number
IR.SBMU.REC.1398.059
Health conditions studied
1
Description of health condition studied
Burn
ICD-10 code
T31.0
ICD-10 code description
Burns involving less than 10% of body surface
2
Description of health condition studied
Superficial burns
ICD-10 code
T31
ICD-10 code description
Burns classified according to extent of body surface involved
3
Description of health condition studied
Diabetic foot ulcer
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus
4
Description of health condition studied
trauma
ICD-10 code
S31.1
ICD-10 code description
Open wound of abdominal wall without penetration into peritoneal cavity
Primary outcomes
1
Description
Wound quality
Timepoint
3 days
Method of measurement
expert visit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention in the intervention group: Six people with skin lesions less than 5 cm in size. Use of autologous growth factor-rich plasma in gel form, bio compatible Scaffold coating in both groups, opens the fifth day after surgery, the wound is washed with normal saline and covered with sterile Vaseline gas and again dressed. Changing the dressing will continue for one day until the transplant is complete.
Category
Treatment - Surgery
2
Description
Intervention in the control group: The site of transplantation is treated in the traditional way. In both groups open the dressing on the fifth day after surgery, the wound is washed with normal saline and covered with sterile Vaseline gas and again dressed. Changing the dressing will continue for one day until the transplant is complete.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti university of Medical sciences, Skin Research Center
Full name of responsible person
Dr. Hamideh Moravvej
Street address
skin research center, Shohada Hospital, Tajrish
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 1507
Email
src@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
Darband St., Qods Sq.
City
Tehran
Province
Tehran
Postal code
1971653313
Phone
+98 21 2271 4248
Email
Proteom@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
Mostafa Rezaei Tavirani
Position
Director of Center
Latest degree
Ph.D.
Other areas of specialty/work
Proteomics
Street address
Darband St., Qods Sq.
City
Tehran
Province
Tehran
Postal code
1971653313
Phone
+98 21 2271 4248
Email
tavirany@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mostafa Rezaei Tavirani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Informatics
Street address
Research managment, 6th Floor, Bldg No.2, Shahid Beheshti University of Medical Sciences, Velenjak.
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2243 9787
Fax
Email
tavirani@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeed Heidari keshel
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
Darband St., Qods Sq.
City
Tehran
Province
Tehran
Postal code
1971653313
Phone
+98 21 2271 4248
Email
saeedhey@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
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
Type and dimension of wound
When the data will become available and for how long
One year
To whom data/document is available
Research delegates
Under which criteria data/document could be used
Supervision
From where data/document is obtainable
Mostafa Rezaei Tavirani
What processes are involved for a request to access data/document