Effect of topical insulin injection on wound healing of split-thickness skin graft donor site in comparison to the placebo
Design
This randomized double-blind clinical trial will be conducted on 30 samples (15 patients) in June 2019. Case and control groups in this study will be both in one patient. The proximal and distal parts of the wound will be selected randomly for injecting the drug or placebo.
Settings and conduct
This randomized double blind clinical trial will conduct in Razi hospital, Tehran. 15 patients will be enrolled in this study who have split-thickness skin graft donor site wound on the anterolateral of their thigh. The wound of every patient will be divided into two control and case segments randomly. NPH Insulin will be injected at the case segment subdermally and the control segment will be injected by normal saline in the same manner. Then transparent dressing will be used for covering the wounds. In the 7th, 14th and 21st-day postoperative periods some photos will be taken. The area of epithelialization in the scale of mm2 will calculate by ImageJ software v1.52 and comparing between case and control groups will be done.
Participants/Inclusion and exclusion criteria
The population of the study will be consisted of patients who undergoing split-thickness skin graft surgery on the anterolateral region of thigh.
Inclusion criteria: skin graft at least more than 10 cm length; age between 18 and 65 years.
Exclusion criteria: aged under 18 years or above 65, history of diabetes, vascular diseases, smoking, and pregnancy.
Intervention groups
Subdermal injection will be done in twelve point of the case site with 2cc of NPH insulin (Exir®, Iran) with a concentration of 1 IU/ml. In control site, 2 cc of normal saline in 12 point will be injected subdermally.
Main outcome variables
The size of the epithelialized area
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111118008122N2
Registration date:2019-06-24, 1398/04/03
Registration timing:retrospective
Last update:2019-06-24, 1398/04/03
Update count:0
Registration date
2019-06-24, 1398/04/03
Registrant information
Name
Sohrab Moradi Bajestani
Name of organization / entity
Tabriz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 1317
Email address
dr.moradi@rocketmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-10, 1398/03/20
Expected recruitment end date
2019-06-15, 1398/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of local insulin injection on the healing process of split-thickness skin graft donor site in comparison to the placebo
Public title
The effect of local insulin injection on the wound healing process
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
STSG donor site at least more than 10 cm length and age between 18 and 65 year-old
Exclusion criteria:
Age below 18 years
Age above 65 years
Diabetes
Malnutrition
History of vascular diseases
Smoking
Pregnancy
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
15 patients will be enrolled in the current study and case and control group will be considered in one patient. Regarding 9 cm width of split-thickness skin graft based on the width of the dermatome and >10 cm length of STSG, two 9×5cm segments in the proximal and distal part of the wound will be chosen as a case or control randomly and subdermal injection will be done with insulin or placebo.
Randomization (investigator's opinion)
Randomized
Randomization description
Using table of random numbers, case and control groups will be chosen (proximal or distal site of the wound).
Blinding (investigator's opinion)
Double blinded
Blinding description
This double-blind study will conduct in such a way that the patients and the assessing group will not know the site of drug injection and the choice of the injection site will be random.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Science, Enghelab St, Poursina Ave,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-10-20, 1397/07/28
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1397.609
Health conditions studied
1
Description of health condition studied
Skin Grafting
ICD-10 code
T86.82
ICD-10 code description
Complications of skin graft (allograft) (autograft)
Primary outcomes
1
Description
evaluating epithelized area for assessing the wound site
Timepoint
َAt day 7, 14 and 21 after STSG
Method of measurement
ImageJ software
Secondary outcomes
empty
Intervention groups
1
Description
In the case group, a single dose of NPH insulin (Exir, Iran) with the concentration of 1IU/ml and the dose of 2 ccs will be injected subdermally at 12 points of the wound. After the intervention, transparent dressing will be used for covering the wound. The wound site will be explored at the 7th, 14th and 21st day of the postoperative period and some photos will be taken. in addition, measuring the blood glucose will be done in the pre and postoperative period in order to prevent insulin side effects such as hypoglycemia.
Category
Treatment - Drugs
2
Description
Control group (Normal saline): It will be injected as a single dose of 2cc in 12 points subdermally like the insulin. After the intervention, transparent dressing will be used for covering the wound. The wound site will be explored at the 7th, 14th and 21st day of the postoperative period and some photos will be taken.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Shahriar Haddady Abianeh
Street address
Tehran Province, Tehran, District 12, Wahdat-e-Islami St.
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5560 9951
Email
dr.smoradib@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shokoufeh Nikfar
Street address
Keshavarz Blvd., Ghods St. Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 81631
Email
rmo@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Sohrab Moradi Bajestani
Position
Fellowship of Plastic Surgery
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Tehran Province, Tehran, District 12, Wahdat-e-Islami St.
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 912 377 0755
Email
dr.smoradib@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahriar Haddady Abianeh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Tehran Province, Tehran, District 12, Wahdat-e-Islami St.
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5560 9951
Email
h_abianeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sohrab Moradi Bajestani
Position
Fellowship of Plastic Surgery
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Tehran Province, Tehran, District 12, Wahdat-e-Islami St.
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 912 377 0755
Email
dr.smoradib@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
All of the data can be shared
When the data will become available and for how long
After statistical analysis
To whom data/document is available
ethical committee
Under which criteria data/document could be used
in order to assess the data
From where data/document is obtainable
Dr. Sohrab Moradi
What processes are involved for a request to access data/document