Comparing the effect of sesame oil and topical silver sulfadiazine 1% on improving the extent of burn and epithelialization of patients with second degree burn
The aim of this study is to compare the topical application of sesame oil and silver sulfadiazine 1% in the treatment of patients with second degree burns. Inclusion criteria: All patients hospitalized with second degree burns in burn ward of Nekoi Hospital of Qom.
Exclusion criteria: Age less than 2 years, comorbid diseases, inhalation burns, third degree burns and burn over 25% of body surface. In this trial, 60 patients are randomly assigned into two groups. Then in case group topical sesame oil (Made by Merck company of Germany) is used and control group will receive silver sulfadiazine 1% ointment (Made by Sina Daroo Company with trade name of Flamexin). The application is so that silver sulfadiazine or sesame oil will be used without any additive and will be placed and covered by a sheet of cellophane on burn wound. The dosage of sesame oil or sulfadiazine is determined based on the extent of the lesion and will be used once a day until recovery. The extent of reduction burns, the need for analgesic and antibiotic compounds, the extent of residual scarring and recovery time in both groups will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201188769N1
Registration date:2012-09-19, 1391/06/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-09-19, 1391/06/29
Registrant information
Name
Seyed Jalal Eshagh Hosseini
Name of organization / entity
Qom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25171181
Email address
j.hosseini@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Qom University of Medical Sciences
Expected recruitment start date
2012-10-22, 1391/08/01
Expected recruitment end date
2013-04-21, 1392/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of sesame oil and topical silver sulfadiazine 1% on improving the extent of burn and epithelialization of patients with second degree burn
Public title
Sesame oil and silver sulfadiazine in second degree burn
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients hospitalized with second degree burns in the burn center of Nekoi Hospital of Qom
Exclusion criteria: Age less than 2 years, comorbidity with diseases, inhalation burns, third degree burns, burns over 25% of body surface
Age
From 2 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This is a single blind study. Patients are not informed of the drugs used after obtaining informed consent. Randomization is based on a predefined random numbers table so that even numbers will be assigned to participate in case group and odd numbers will be in the control group
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qom University of Medical Sciences
Street address
Qom University of Medical Sciences, Lavasani St., Qom
City
Qom
Postal code
Approval date
2011-10-02, 1390/07/10
Ethics committee reference number
34/12078/پ
Health conditions studied
1
Description of health condition studied
Burn
ICD-10 code
T30.2
ICD-10 code description
Burn of second degree, body region unspecified
Primary outcomes
1
Description
The extent of burn
Timepoint
Before the intervention and every three days until epithelialization
Method of measurement
Ruler and extent based on square centimeters
Secondary outcomes
1
Description
The need for antibiotic
Timepoint
Every day until discharge
Method of measurement
Number of doses
2
Description
The need for analgesic drugs
Timepoint
Every day until discharge
Method of measurement
Number of doses
3
Description
The extent of residual scar
Timepoint
Weekly after the intervention until one month after full recovery
Method of measurement
Ruler and extent based on square centimeters
Intervention groups
1
Description
For the patients in control group topical Silver sulfadiazine 1% ointment (Made by Sina Daroo company of Iran, with trade name of Flamexin) is used once a day.
The dosage is determined based on the extent of the lesion
Category
Treatment - Drugs
2
Description
For the patients in case group pure topical sesame oil (Made by Merk company of Germany) is used once a day.
The dosage is determined based on the extent of the lesion
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Nekoi Hospital
Full name of responsible person
Seyed Jalal Eshagh Hosseini, MD.
Street address
Nekoi Hospital, Azar St., Qom
City
Qom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Education, Research and Technology of Qom University of Medical Sciences
Full name of responsible person
Ali-Reza Koohpayee
Street address
Qom University of Medical Sciences, Vice chancellor for Education, Research and Technology, Lavasani St., Qom
City
Qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Education, Research and Technology of Qom University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Seyed Jalal Eshagh Hosseini, MD.
Position
Surgeon, Assistant professor
Other areas of specialty/work
Street address
Nekoi Hospital, Azar St., Qom
City
Qom
Postal code
Phone
+98 25171181
Fax
Email
j.hosseini@muq.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Seyed Jalal Eshagh Hosseini, MD.
Position
Surgeon, Assistant professor
Other areas of specialty/work
Street address
Nekoi Hospital, Azar St., Qom
City
Qom
Postal code
Phone
+98 25171181
Fax
Email
j.hosseini@muq.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Seyed Jalal Eshagh Hosseini, MD.
Position
Surgeon, Assistant professor
Other areas of specialty/work
Street address
Nekoi Hospital, Azar St., Qom
City
Qom
Postal code
Phone
+98 25171181
Fax
Email
j.hosseini@muq.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)