This study was performed to assess and compare 2 degree burn's healing time in two methods of dressing by Fundermol herbal ointment and %1 Silver sulfadiazine ointment in 50 patients of Imam Mousa Kazem hospital in Isfahan. The patients, aged 2-60 years old, with burning wounds area between 1-10% of body surface were randomly assigned into intervention or control group to receive wound dressing with Fundermol or Silver Sulfadiazine 1%, daily, until complete wound healing. The time to healing was measured and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012275477N1
Registration date:2011-03-08, 1389/12/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-03-08, 1389/12/17
Registrant information
Name
Mohammad Heidari
Name of organization / entity
Services Shahrekord University of Medical Sciences and Health
Country
Iran (Islamic Republic of)
Phone
+98 38 2422 6903
Email address
heidari@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor Research, Isfahan University of Medical Sciences and Health Services
Expected recruitment start date
2007-09-23, 1386/07/01
Expected recruitment end date
2008-01-21, 1386/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of second degree burns healing time in two methods of dressing by Fundermol herbal ointment and %1 Silver sulfadiazine ointment
Public title
Comparison of Second degree burns healing time in two methods of dressing by Fundermol (Alpha) herbal ointment and %1 Silver sulfadiazine ointment in Imam Mousa Kazem hospital 2008
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: age 2-60 years, burn only in contact with heat resource or hot fluids, burn area between 1- 10% according to Land-Browder table, less than 6 hours passed from burning occurrence, normal Hb level, normal total protein level, second degree burn, burn on body and/or extremities, no wound infection
Exclusion Criteria: presence of underlying diseases such as anemia, diabetes, cardiovascular disease, malignancy and immune insufficiency, Burn wound damage during care, need to consumption of immune supportive drugs, corticosteroids or chemotherapy, failure to cooperation, pregnancy, presence of trauma
Age
From 2 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences and Health Services
Street address
Research vice chancellor, Isfahan University of Medical Sciences and Health Services, Hezarjarib street, Isfahan
City
Isfahan City
Postal code
Approval date
2007-09-13, 1386/06/22
Ethics committee reference number
387027
Health conditions studied
1
Description of health condition studied
Burn
ICD-10 code
T29.2
ICD-10 code description
Burns of multiple regions, no more than second-degree burns mentioned
Primary outcomes
1
Description
Second Degree Burns Healing Sore
Timepoint
Daily Inspection of Reveal Complete Recovery Burn Sore
Method of measurement
Daily Inspection of Reveal Complete Recovery Burn Sore
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 1mm of Fundermol ointment was rubbed on the wound, daily, After cleaning wound with aseptic N/S 0.9 %, wound has been placed in air until drying completely. Then, 1mm of Fundermol ointment was rubbed on the wound by tongue blade and has been dressed with nylon. Dressings were changed daily until wound recovered completely.
Category
Treatment - Drugs
2
Description
Intervention group: 3mm of Silver Sulfadiazine 1% ointment was rubbed on the wound. After cleaning wound with aseptic N/S 0.9 %, wound has been placed in air until drying completely. Then, 3mm of Silver Sulfadiazine 1% ointment was rubbed on the wound by tongue blade and has been dressed with nylon. Dressings were changed daily until wound recovered completely.