The Comparison of the effect of hydroalcoholic extract gel of Arnebia euchroma and Silver Sulfadiazin and Alpha ointments on wound healing in patients with heat-induced superficial skin wounds
The aim of the present study is to investigate the healing effects of Arnebia euchroma extract gel on heat-induced skin wounds and compare it with commonly prescribed topical agents namely silver sulfadiazine ointment and Alpha ointment. Patients with skin wounds with less than 2 square-centimeters surface which are induced by heat or burn will be included after giving informed consents and will be divided into five groups of 300 individuals. Groups 1 to 5 will receive Silver Sulfadiazine ointment, Alpha ointment, Arnebia euchroma 5% gel, Arnebia euchroma 10% gel, and Arnebia euchroma 20% gel, respectively, twice daily till complete reepithelization of the wound surface. Participants have the right to leave at any time during the study. Those who show any adverse effects or reaction regarding their treatment or show inadequate wound healing will be excluded to receive another proper treatment. At the end wounds will be evaluated for any scar formation, infection, and duration of reepithelization and wound closure rate.
General information
Acronym
AETRIAL
IRCT registration information
IRCT registration number:IRCT2013102115102N1
Registration date:2014-02-11, 1392/11/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-02-11, 1392/11/22
Registrant information
Name
Soheil Ashkani-Esfahani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1626 2033
Email address
ashkanis@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences, Shiraz, Iran
Expected recruitment start date
2014-01-03, 1392/10/13
Expected recruitment end date
2014-09-30, 1393/07/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of the effect of hydroalcoholic extract gel of Arnebia euchroma and Silver Sulfadiazin and Alpha ointments on wound healing in patients with heat-induced superficial skin wounds
Public title
The effect of an herbal extract (Arnebia euchroma) for wound healing
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Having wounds with 2cm area or less; Having no other systemic diseases affecting the wound healing process; Having no other dermatological diseases; Filling informed consent and participating in using the prescribed drugs; Having wounds caused by traumatic injuries or burns
Exclusion criteria:Having wounds sized more than 2 cm; Having any systemic diseases or dermatological diseases; Willing to leave the study at any time during the treatment; Having wounds caused by any other reasons than traumatic injury or burns
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
300
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
Ethics committee of Shiraz University of Medical Sciences
Street address
Karim Khan Zand St, Shiraz Medical school
City
Shiraz
Postal code
0
Approval date
2013-12-29, 1392/10/08
Ethics committee reference number
92-01-21-6743
Health conditions studied
1
Description of health condition studied
heat-induced Skin wounds
ICD-10 code
T30.1
ICD-10 code description
Burn of first degree, body region unspecified
2
Description of health condition studied
heat-induced skin wounds
ICD-10 code
T30.2
ICD-10 code description
Burn of second degree, body region unspecified
3
Description of health condition studied
Heat-induced skin wounds
ICD-10 code
T31.0
ICD-10 code description
Burns involving less than 10% of body surface
Primary outcomes
1
Description
wound closure rate
Timepoint
at the begining of the study and then daily till the closure of the wound
Method of measurement
ruler
Secondary outcomes
1
Description
Scar formation
Timepoint
at the end
Method of measurement
observation
2
Description
wound infection
Timepoint
during and at the end of the study
Method of measurement
Culture
Intervention groups
1
Description
Group E5: patients were treated with Arnebia euchroma gel 20% twice daily for 28 days. The gel covered the wound properly then dressed with bandages in the standard method.
Category
Treatment - Drugs
2
Description
Group E3: patients are treated with Arnebia euchroma gel 5% twice daily for 28 days. The gel covere the wound properly then dresse with bandages in the standard method.
Category
Treatment - Drugs
3
Description
Group P3: patients are treated with Arnebia euchroma gel 20% twice daily for 28 days. The gel covere the wound properly then dresse with bandages in the standard method.
Category
Treatment - Drugs
4
Description
Group E4: patients are treated with Arnebia euchroma gel 10% twice daily for 28 days. The gel covere the wound properly then dresse with bandages in the standard method.
Category
Treatment - Drugs
5
Description
Group P2: patients are treated with Arnebia euchroma gel 10% twice daily for 28 days. The gel covere the wound properly then dresse with bandages in the standard method
Category
Treatment - Drugs
6
Description
Group E1: patients are treated with Silver sulfadiazine ointment twice daily for 28 days. The ointment covere the wound properly then dresse with bandages in the standard method.
Category
Treatment - Drugs
7
Description
Group E2: patients are treated with Alpha ointment twice daily for 28 days. The ointment covere the wound properly then dress with bandages in the standard method.
Category
Treatment - Drugs
8
Description
Group P1: patients are treated with Arnebia euchroma gel 5% twice daily for 28 days. The gel cover the wound properly then dress with bandages in the standard method.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faghihi Hospital of Shiraz University of Medical Sciences
Full name of responsible person
Soheil Ashkani Esfahani
Street address
Student Research Committee, Shiraz Medical School, Karimkhan Zand St
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
SadraTech Company
Full name of responsible person
AliAsghar Karimi
Street address
Farahmandfar hospital, Ghasredasht St
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
SadraTech Company
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
Shiraz University of Medical Sciences
Full name of responsible person
Soheil Ashkani Esfahani
Position
Medical Student (intern), The Secretary of Student Research Committee
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand St
City
Shiraz
Postal code
Phone
+98 917 339 7040
Fax
Email
soashkani@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ethics Committee of Shiraz University of Medical School
Full name of responsible person
Sedigheh Ebrahimi
Position
MD, Deputy President of Ethics Committee
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand St
City
Shiraz
Postal code
Phone
+98 917 112 9908
Fax
Email
sedighehebrah@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Soheil Ashkani Esfahani
Position
Medical Student (intern)
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand St.
City
Shiraz
Postal code
Phone
00
Fax
Email
soashkani@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)