Comparative study of three methods of subcutaneous injection of insulin and amnion membrane and simple dressing with petroleum jelly in the repair of donor graft site in second and third degree burns in a period of one year in Taleghani Hospital of Ahvaz
Comparative study of three methods of subcutaneous injection of insulin, amniotic membrane and simple dressing with petroleum gauze in healing of donor graft site in second and third degree burn patients.
Design
People enter this study according to inclusion criteria. The study will be conducted on 120 patients in Ahvaz accident and burn hospital, and the intervention and control will be on one patient. A skin graft with a relative thickness of three sections of 5 x 9 cm in proximal 1.3, medial 1.3 and distal 1.3 of the wound will be randomly selected as case and control. subcutaneous insulin injection, amniotic membrane, simple dressing with petroleum gauze will be used as a dressing in order to compare these three methods in terms of donor site healing.
Settings and conduct
This study is an interventional study of the clinical trial type and the study site is Taleghani Burn Accident Hospital in Ahvaz, and the study subjects were 120 patients with second and third degree burns admitted to the hospital.
Participants/Inclusion and exclusion criteria
Second and third degree burn patients referred to Ahvaz Taleghani Burn Accident Hospital
Patients aged 18 to 65 years were included in the study.
Pregnant women, children, patients with underlying problems such as diabetes, cardiovascular problems, chronic kidney disease, chronic liver disease, vascular collagen diseases, and chronic skin diseases and receiving immunosuppressive drugs were excluded from the study
Intervention groups
Every Patients aged between 18 to 65 years old with second and third degree burns who need Split thickness skin graft (STSG) measured more than 15 cm
Main outcome variables
the area of the epithelialized area to follow the condition of the wound
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240124060790N1
Registration date:2024-02-14, 1402/11/25
Registration timing:registered_while_recruiting
Last update:2024-02-14, 1402/11/25
Update count:0
Registration date
2024-02-14, 1402/11/25
Registrant information
Name
Ali Alizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3554 7996
Email address
alizadeh.ali@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-06, 1402/10/16
Expected recruitment end date
2025-01-05, 1403/10/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of three methods of subcutaneous injection of insulin and amnion membrane and simple dressing with petroleum jelly in the repair of donor graft site in second and third degree burns in a period of one year in Taleghani Hospital of Ahvaz
Public title
Effect of insulin injection,amniotic membrane and simple dressing with petroleum gauze in wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients between 18 to 65,
Patients with second and third degree burn
Exclusion criteria:
Pregnant women
Patients with underlying diseases such as Diabetes, chronic kidney disease، chronic liver disease, peripheral vascular disease, cardiovascular disease, collagen vascular disease, chronic skin disease ranging from autoimmune diseases to skin malignancies
Heavy smokers
Immunosuppressive medication users
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
This study will be conducted on 120 patients and the intervention and control will be on one patient. Considering the width of the dermatome at 9 cm and the length of the skin graft at least 15 cm with relative thickness, three sections of 5 x 9 cm in the proximal, medial and distal of the wound will be randomly selected as cases and controls. Insulin, placebo (normal saline serum) will be used subcutaneously and amnion membrane as a cover in the proximal, medial and distal areas of the mentioned wound.
Description of how to randomize: Using the table of random numbers, case and control groups are randomly selected between proximal wound, medial wound and distal wound
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 Ahvaz Jondishapur University of Medical Sciences
T20. 20XA:Burn of second degree of head, face, and neck, unspecified site, initial encounter. T21. 30XA :Burn of third degree of trunk, unspecified site, initial encounter. T86.822 :for skin graft (allograft)(autograft)
Primary outcomes
1
Description
the area of the epithelialized area to follow the condition of the wound
Timepoint
مقاطع زمانی اندازهگیری :روز 7، 14 و 21 پس از انجام مطالعه
Method of measurement
Examining the area of the epithelialized area using ImageJ software
Secondary outcomes
empty
Intervention groups
1
Description
Description of the intervention in the case group: NPH insulin made by Elixir factory will be injected subcutaneously in a single dose with a concentration of 1 unit per milliliter with a dose of 2 cc in 10 points. After the intervention, the wounds of the dressing patients become clear. . In addition, blood sugar measurement will be done in order to prevent side effects such as hypoglycemia in patients before and after surgery
Category
Treatment - Surgery
2
Description
Control group:( Description of the intervention of the control group): The placebo in this study is normal saline serum, which will be injected subdermally in 10 points with a volume of 2 cc as a single dose like insulin. After the intervention, the wounds of the dressing patients become clear. On the 7th, 14th, and 21st days after the operation, the wound will be examined and a picture of the position will be taken
Category
Treatment - Surgery
3
Description
Intervention group: In the other intervention group, the amniotic membrane is used as a wound cover. On the 7th, 14th, and 21st days after the operation, the wound will be examined and a picture of the position will be taken.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani burn hospital,Ahvaz Jondishapur University of Medical Sciences