1. Home
  2. Approved trials
  3. » فارسی

Investigating the effects of using new aluminum-based dressings versus silver sulfadiazine ointment in the treatment of patients with second- and third-degree burns

Protocol summary

Study aim
To investigate the healing status, reduction of wound surface, wound infection, reduction of pain, rate of healing, and length of hospital stay of patients using new dressings compared to silver sulfadiazine ointment in patients with 2nd and 3rd degree burns.
Design
A randomized, open-label, parallel-group, controlled clinical trial, phase 3, on 74 patients
Settings and conduct
Patients with 2nd and 3rd degree burns admitted to Taleghani Hospital in Ahvaz, after excision of the wounds in the operating room, are divided into two groups: a new aluminum-based dressing and the other group is given SSD ointment, and the wound condition is re-evaluated 5 days later.
Participants/Inclusion and exclusion criteria
Patients with 2nd and 3rd degree burns, failure to use medications effective in wound healing, and wounds without trauma or infection are inclusion criteria. Patients with wounds containing necrotic and infected tissue, and patients with trauma and first degree burns are excluded
Intervention groups
Patients with 2nd and 3rd degree burns hospitalized under a new aluminum-based dressing compared to a dressing with silver sulfadiazine ointment
Main outcome variables
The results of this study will greatly assist us in selecting the type of dressing to accelerate the healing process, reduce the risk of infection, reduce the surface area and the number of cases requiring dressings in second- and third-degree burn wounds, as well as reduce the use of antibiotics and prevent the development of drug resistance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250802066732N1
Registration date: 2025-08-07, 1404/05/16
Registration timing: prospective

Last update: 2025-08-07, 1404/05/16
Update count: 0
Registration date
2025-08-07, 1404/05/16
Registrant information
Name
Abbasali Eskandarion
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 9748
Email address
eskandarion.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-08-23, 1404/06/01
Expected recruitment end date
2026-08-23, 1405/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of using new aluminum-based dressings versus silver sulfadiazine ointment in the treatment of patients with second- and third-degree burns
Public title
Investigating the effects of new dressing versus ointment in the treatment of patients with second-and third-degree burns
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Burn diagnosis,second and third degree Wounds without trauma and infection Not using effective drugs for wound healing
Exclusion criteria:
First-degree burn Patient presented late and did not have an initial wound Wounds containing necrotic and infected tissue
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 74
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized block design based on burn type (above 30%and less30%)and two types of treatment(new aluminum-based dressing and silver sulfadiazine ointment)
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Does not have

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz University of Medical Sciences
Street address
No.5 Nosrat 2 Alley, Gol9 Ave., Babol
City
Babol
Province
Mazandaran
Postal code
4714766548
Approval date
2025-08-02, 1404/05/11
Ethics committee reference number
IR.AJUMS.REC.1404.254

Health conditions studied

1

Description of health condition studied
Second and third degree burns
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Wound healing, which is estimated based on its appearance and characteristics, wound infection, which is measured by wound appearance criteria, and length of stay, which is expressed as the number of days spent in the hospital from admission to discharge.
Timepoint
5 days from the start of the dressing and at the same intervals if necessary
Method of measurement
Check the condition of the wound

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients with 2nd and 3rd degree burns who were treated with aluminum-based dressings and were re-evaluated for wound status after 5 days.Aluderm dressing, manufactured by the German company sohngen, is placed directly on the wound, and a special dressing gauze is placed on it and a bandage is applied. Aluderm is made of trivalent aluminum, is flexible, and fits comfortably on the limb.
Category
Treatment - Drugs

2

Description
Control group: Patients with 2nd and 3rd degree burns who are dressed with silver sulfadiazine ointment and their dressings must be changed daily. This cream is available in 50 gram tubes manufactured by Iran Najou and Sobhan Darou pharmaceutical companies and is applied directly to the burn wound to completely cover the wound, and the dressing is changed once or twice a day.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani Accident and Burn Hospital, Ahvaz
Full name of responsible person
Dr. Seyed Saheb Hosseini Nejad
Street address
Phase 2 padadshahr, Hejrat Boulevard, Taleghani Hospital, Padadshahr
City
Ahvaz
Province
Khouzestan
Postal code
6187954386
Phone
+98 61 3554 7992
Fax
+98 61 3554 0252
Email
htaleghani@ajums.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Abdollah Rafiei
Street address
Phase 2 padadshahr, Hejrat Boulevard, Taleghani Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6187954386
Phone
+98 61 3554 7992
Fax
+98 61 3554 0252
Email
htaleghani@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
70
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
abbasali eskandarion
Position
Plastic and Reconstructive Surgery Resident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Phase 2 padadshahr, Hejrat Blvd., Taleghani Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6187954386
Phone
+98 61 3554 7992
Fax
+98 61 3554 0252
Email
htaleghani@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Seyed Saheb Hosseini Nejad
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Plastic and reconstructive surgery
Street address
Phase 2 padadshahr, Hejrat Blvd., Taleghani Hospital,
City
Ahvaz
Province
Khouzestan
Postal code
6187954386
Phone
+98 61 3554 7992
Fax
+98 61 3554 0252
Email
hosseininejad-s@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Abbasali eskandarion
Position
Plastic and Reconstructive Surgery Resident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Phase 2 padadshahr, Hejrat Blvd., Taleghani Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6187954386
Phone
+98 61 3554 7992
Fax
+98 61 3554 0252
Email
eskandarion.a@ajums.ac.ir

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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...