Randomized clinical trial of standardized topical formula containing standard extracts of Arnebia euchroma, Malva sylvestris and sesame oil (less than 20%) vs. Silversulfadiazine cream on wound healing in 2nd degree burns
Objectives: Wound healing properties( in 2nd degree burns) of a patented topical formula containing standard extracts of Arnebia euchroma, Malva sylvestris and sesame oil (less than 20%), formulated in Shiraz School of Pharmacy according to pharmacognostic and pharmaceutical standards will be compared with silver sulfadiazine(1%) in a single-blind randomized clinical trial. Design and setting conducts: A single-blind randomized clinical trial will be performed with two 25 persons groups after explanation the procedure for patients and filling out the informed consent forms by them. Participants including major eligibility criteria: Patients aged between 20-60 years old with 2nd degree burn wounds. Intervention: wounds will be dressed up with either silver sulfadiazine or our new formulated ointment according to randomization every other day. Data from wounds are reported by a physician and process of healing will be photographed until epithelialization of wounds. Main outcome measures (variables): The surface of wounds according planimetric method will be calculated and compared in two groups. Main outcome measures: Collected observations before and after intervention will be compared and data will be analyzed with SPSS and their comparison will be performed with T-test..
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203059204N1
Registration date:2014-04-28, 1393/02/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-04-28, 1393/02/08
Registrant information
Name
Azadeh Hamedi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3242 4127
Email address
hamediaz@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Research, Shiraz University of Medical Sciences
Expected recruitment start date
2012-07-01, 1391/04/11
Expected recruitment end date
2014-12-31, 1393/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized clinical trial of standardized topical formula containing standard extracts of Arnebia euchroma, Malva sylvestris and sesame oil (less than 20%) vs. Silversulfadiazine cream on wound healing in 2nd degree burns
Public title
Randomized clinical trial of standardized topical formula containing standard extracts of Arnebia euchroma, Malva sylvestris and sesame oil (less than 20%) vs. Silversulfadiazine cream on wound healing in 2nd degree burns
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Patients aged between 20 to 60 years old; 2nd degree burn wounds; burn surface area up to 5%
Exclusion criteria: Epilepsy;Diabetes; Cardiovascular diseases; pregnancy; Breast feeding; electrical and respiratory burns
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethical committee, Shiraz University of Medical Sciences
Street address
Vice-Chancellery of Research and Technology, Shiraz University of Medical Sciences, Zand Ave., Shiraz, Iran
City
shiraz
Postal code
71345-1978
Approval date
2012-02-04, 1390/11/15
Ethics committee reference number
CT- 90 - 5935
Health conditions studied
1
Description of health condition studied
provides a standard herbal formulation to heal burn wounds
ICD-10 code
T21,T22,T2
ICD-10 code description
Burn and corrosion of trunk -Burn and corrosion of shoulder and upper limb -Burn and corrosion of wrist and hand -Burn and corrosion of hip and lower limb, except ankle and foot -Burn and corrosion of ankle and foot
Primary outcomes
1
Description
wound healing time
Timepoint
daily
Method of measurement
time between admission and epithelialization or preparation for skin graft
2
Description
surface area of wounds needed to be grafted
Timepoint
daily
Method of measurement
by ruller
Secondary outcomes
1
Description
allergy to applied treatment - infection
Timepoint
21day
Method of measurement
visit by expert physician
Intervention groups
1
Description
Intervention: Dressing with patented topical herbal formulation containing extracts of Arnebia euchroma, Malva sylvestris and sesame oil (less than 20%) after disinfection of wounds according to standard method every other day by responsible physician. According to patient conditions and wound types the treatment will last 1-3 weeks.
Category
Treatment - Drugs
2
Description
Control group: Dressing the wounds using silver sulfadiazine manufactured by Sobhan Pharmaceutical company after disinfection of wounds according to standard method every other day by physician in hospital and will last between 1 week to 3 weeks (depends on wound healing)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghotbedin burn Hospital
Full name of responsible person
Dr Ali Akbar Mohammadi
Street address
Ghotbedin burn Hospital, Fakhr abad street
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Ali Poostforooshfard
Street address
Vice-Chancellery of Research and Technology, Shiraz University of Medical Sciences, Zand Ave., Shiraz, Iran
City
Shiraz
Grant name
905935
Grant code / Reference number
905935
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor for Research, Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Ali Akbar Mohammadi
Position
Plastic Surgeon, Assistant Professor
Other areas of specialty/work
Street address
Shiraz Burn Research Center,Ghotbeddin Shirazi Hospital, Fakhr Abad st,Shiraz Shiraz
City
Shiraz
Postal code
54733-71638
Phone
+98 71 1820 8880
Fax
+98 71 1821 7090
Email
mohamadiaa@sums.ac.ir; burnres1@sums.ac.ir
Web page address
http://hburn.sums.ac.ir/connection/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Azadeh Hamedi; Dr Ali Akbar Mohammadi; Dr Gholamhossein Yousefi; Dr Alireza Salehi
Position
Ph D in Pharmacognosy; Plastic Sergeon; PhD in Pharmaceutics; MD in Epidemiology
Other areas of specialty/work
Street address
Shiraz Burn Research Center,Ghotbeddin Shirazi Hospital, Fakhr Abad street,Shiraz, Iran