Protocol summary

Study aim
Comparison of healing of 2nd and 3rd degree burns in dressing with silver sulfadiazine ointment compared to povidone iodine in 30% to 50% burns in a year in Taleghani Hospital, Ahvaz
Design
It is a double-blind study, a phase 3 clinical trial with a parallel group design of 82 patients. A randomized chain was used to enter the study using the Sealed Envelope online software.
Settings and conduct
Patients are selected based on admission criteria in Taleghani Hospital, Ahvaz, and randomly divided, and then each patient is treated with only one treatment, i.e. silver sulfadiazine dressing until the end of treatment, the second group is treated with povidone iodine impregnated gauze dressing until the end of the course, and then Each of them is compared in terms of the rate and speed of recovery, the patient's tolerance and cooperation during the period, the number of times of wound excision and going to the operating room, and the cost of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The percentage of 2nd and 3rd-degree burns is between 30% and 50%. Patients aged between 20 and 65 years Not having underlying diseases that interfere with wound healing (diabetes, neurovascular, chronic kidney disease) Not having any underlying skin diseases (ehlersdanlers, pemphigus). Exclusion criteria: Having underlying anemia pregnant women
Intervention groups
Patients with 2nd and 3rd degree burns and with an area of 30% to 50% of the body surface and based on the inclusion criteria are included in the study.
Main outcome variables
Wound healing speed, pain level, inflammation level, side effects

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240126060819N1
Registration date: 2024-04-10, 1403/01/22
Registration timing: registered_while_recruiting

Last update: 2024-04-10, 1403/01/22
Update count: 0
Registration date
2024-04-10, 1403/01/22
Registrant information
Name
Mohammad Basereh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3554 7996
Email address
basereh.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2025-01-20, 1403/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the healing effect of dressing 2nd and 3rd degree burns with silver sulfadiazine cream compared to povidone iodine in patients with 30% to 50% burns: a clinical trial
Public title
Comparison of the healing effect of silver sulfadiazine cream compared to povidone iodine in patients with 30% to 50% burns: a clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Burning degrees 2 and 3 The age range of the patient is between 20 and 65 years old Burning percentage between 30% and 50%
Exclusion criteria:
Patient with underlying diseases that disrupt wound healing, such as underlying skin disease. Pregnant women Having an underlying anemia
Age
From 20 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
• Randomization method and description of each method: block 4 • Randomization unit: individual • Randomization tool: online randomization (https://www.sealedenvelope.com/), sealed envelope • How to make a random sequence: create It will be done randomly. On the web (https://www.sealedenvelope.com). After selecting Create list, it specifies the number of groups (two groups), the block size (block of 4) and the length of the list (80) and based on that, it provides the randomization list. • Explanation of allocation concealment: sealed envelopes that are assigned to each participant upon arrival and are placed in one of two groups based on that.
Blinding (investigator's opinion)
Double blinded
Blinding description
It is a double-blind study, so that only the attending physician knows about the dressing method and the second surgeon supervises the wound healing, and the patient and staff are not informed. After the participants were evaluated in terms of the criteria for inclusion and exclusion the study, a random chain of the sample size is created using the Silden Volup online software, and the people are added to this chain in the order of their entry into the study. The one that was made is imported.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Ahvaz Jundishapur University of Medical Sciences
Street address
Room 4, ground floor, Ahvaz Jundishahpour University of Medical Science, Vice President of Research and Technology Development , University City, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2024-01-17, 1402/10/27
Ethics committee reference number
IR.AJUMS.REC.1402.557

Health conditions studied

1

Description of health condition studied
Burns
ICD-10 code
T21
ICD-10 code description
Burn and corrosion of trunk

Primary outcomes

1

Description
Burn wound healing speed
Timepoint
Before the start of the intervention and 5 days and 10 days after the start of the intervention
Method of measurement
Wound healing score measurement table

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group (1): The dressing of this group is performed using fully impregnated gauze with a 10% povidone-iodine solution as a two-layer dressing after initial cleansing with sterile normal saline. In order for the gauzes to be fully effective, they need to be completely saturated with povidone-iodine. Initially, two layers of povidone iodine-impregnated gauze are placed on the wound, followed by a layer of dry gauze on top. To prevent drying, this dressing is changed twice a day, every 12 hours. This procedure prevents the formation of crust and dryness on the surface of the wound, which would hinder further penetration of povidone-iodine into the wound, and as a result, it acts more effectively. This process is repeated in the same manner for a duration of 72 hours, after which the wound is evaluated for the need for subsequent surgical debridement.
Category
Treatment - Drugs

2

Description
Intervention group (2): A dressing using 1% silver sulfadiazine ointment was applied. After covering the wound with a layer of moist sterile gauze, a layer of dry sterile gauze is applied. The dressings are changed daily, and the wound site is washed and cleaned with normal saline sterile solution, followed by the application of a dressing under the same conditions. This process is repeated over the next 72 hours. After that, the need for further surgical debridement of the wound will be evaluated.
Category
Treatment - Drugs

3

Description
Control group: simple dressing with Vaseline gauze was performed (Post-Operative Dressing). Burn wounds were dressed with a thin layer of Vaseline gauze as a two-layer dressing, consisting of a moist sterile gauze layer followed by a dry sterile gauze layer. The dressings were changed daily, and the wound place was washed and cleaned with normal saline sterile solution. The dressing was then repeated under the same conditions. This process was repeated over the next 72 hours, and after that, the wound was evaluated for the need for further surgical debridement.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Alireza Rafati Navaei
Street address
At the corner of Hijrat Square, Phase 2 of Padadshahr, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6133911151
Phone
+98 61 3554 0256
Fax
+98 61 3554 0256
Email
htaleghani@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahtab Farhadi
Street address
Golestan Blvd, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
15794- 61357
Phone
+98 916 617 5513
Fax
+98 61 3332 5431
Email
aduaum@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Abdulreza Sheikhi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Farvardin Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
009861337430011
Email
sheikhi-a@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Basereh
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Taleghani hospital
City
Ahvaz
Province
Khouzestan
Postal code
6133911151
Phone
+98 61 3554 0256
Email
Basereh.m@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Basereh
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Taleghani hospital
City
Ahvaz
Province
Khouzestan
Postal code
6133911151
Phone
+98 61 3554 0256
Email
Basereh.m@ajums.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
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
The only results related to the consequences and outcomes of the intervention are publishable. They are made available to researchers for further investigation.
When the data will become available and for how long
The data become available after the paper is printed and published.
To whom data/document is available
Researchers employed in academic and scientific institutions
Under which criteria data/document could be used
In meta-analysis studies and conducting similar studies.
From where data/document is obtainable
Please refer to the Deputy of Research and Technology at Jundishapur University of Medical Sciences. Within submitting a proposal and obtaining an ethics code from the ethics committee of this university, access to data should be provided for researchers.
What processes are involved for a request to access data/document
Researchers can access the data through correspondence with the Deputy Office of Research and Technology at the university and since obtaining the ethics code from the Ethics Committee in Ahvaz University of Medical Sciences.
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