Introduction: Aloe vera has been traditionally used for burn healing but clinical evidence remains unclear. This study compared the effects of silver sulfadiazine 1% cream and Aloe vera gel dressing on burn wound healing. Methods: This randomized, controlled trial was done in vali Asr Hospital of Arak city in Iran. The patients were randomly divided into two equal groups: group I (n = 32), treated topically with silver sulfadiazine 1% cream and group II (n = 32), control group, treated topically with Aloe vera gel. Wound healing process wsa examined using the wound assessment tool of Bats-Jensen. Analysis of variance REMANOVA was used to evaluate the differences of wound healing parameters between treated and control groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012123011940N1
Registration date:2013-02-10, 1391/11/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-02-10, 1391/11/22
Registrant information
Name
Azam Malek Hoseini
Name of organization / entity
Arak University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1226 7892
Email address
m.saeedi@arak.ac.ir
Recruitment status
Recruitment complete
Funding source
governmental
Expected recruitment start date
2010-04-21, 1389/02/01
Expected recruitment end date
2012-10-22, 1391/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of aloe vera gel, compared to 1% silver sulfadiazine cream on second-degree burn
Public title
Effect of aloe vera in the treatment of burn wounds
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: subjects with second degree burns less than 15% of the body surface area; max 6 hours after the beginning of burning; burnt wound without any contamination; not using any substance except potable water on wounds; not having any symptomatic infections in the body; not having any underlying immune deficiency diseases, diabetes, cancer, AIDS, hypertension, and ...; willingness to participate in the research and able to answer the questions. Exclusion criteria: Patients who are admitted in the burn unit for other reasons; patients who want to withdraw; any allergy or sensitivity to the treatment drug.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Basij Square
City
Arak
Postal code
38481-7-6941
Approval date
2012-06-21, 1391/04/01
Ethics committee reference number
2-124-90
Health conditions studied
1
Description of health condition studied
Burn
ICD-10 code
T20,T21,T2
ICD-10 code description
Burns
Primary outcomes
1
Description
wound healing
Timepoint
days 1, 7, 15
Method of measurement
The wound assessment tool baets - Jensen
2
Description
Pain at dressing change
Timepoint
days 1, 7, 15
Method of measurement
The Numeric Pain Scale
Secondary outcomes
empty
Intervention groups
1
Description
The experimental group was treated with aloe vera gel for two weeks.
Category
Treatment - Drugs
2
Description
The control group was treated with Sulfadiazine 1% for two weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali Asr Hospital
Full name of responsible person
Azam Malekhoseini
Street address
Ayatollah Ghafari St., Vali Asr (aj)
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Mdical sciences
Full name of responsible person
Davood Hekmatpoo
Street address
Basij Square
City
Arak
Grant name
تفویض اختیاری دانشکده پرستاری مامایی
Grant code / Reference number
763
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Mdical 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
Arak University of Medical Sciences
Full name of responsible person
Azam Malekhoseini
Position
MS in Nursing
Other areas of specialty/work
Street address
Arak University of Medical Sciences
City
Arak
Postal code
3848176941
Phone
+98 86 1226 7892
Fax
+98 86 1417 3639
Email
malekhoseni.aram@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Azam Malekhoseini
Position
MS in Nursing
Other areas of specialty/work
Street address
Arak University of Medical Sciences
City
Arak
Postal code
3848176941
Phone
+98 86 1226 7892
Fax
Email
malekhoseni.aram@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Azam Malekhoseini
Position
MS in Nursing
Other areas of specialty/work
Street address
Arak University of Medical Sciences
City
Arak
Postal code
3848176941
Phone
+98 86 1226 7892
Fax
+98 86 1417 3521
Email
malekhoseni.aram@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)