Comparison of second degree burns healing time in two methods of dressing by Sea buckthorn herbal ointment and %1 Silver sulfadiazine ointment in Imam Mousa Kazem hospital 2015
This study performe to assess and compare 2 degree burn's healing time in two methods of dressing by sea buckthorn herbal ointment and %1 Silver sulfadiazine ointment in 60 patients of Imam Mousa Kazem hospital in Isfahan. The patients, aged 18-60 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 sea buckthorn or Silver Sulfadiazine 1%, daily, until complete wound healing. The time to healing will measured and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015081523623N1
Registration date:2015-11-03, 1394/08/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-03, 1394/08/12
Registrant information
Name
Saeid Shafiee
Name of organization / entity
Isfahan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 31 3457 2219
Email address
s-shafiee@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences and Health Services
Expected recruitment start date
2015-10-17, 1394/07/25
Expected recruitment end date
2015-11-21, 1394/08/30
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 Sea buckthorn herbal ointment and %1 Silver sulfadiazine ointment in Imam Mousa Kazem hospital 2015
Public title
To comprare the effect of sea buckthorn and 1% Silver Sulfadiazine dressing on burns healing time
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1-age 18-60 years old
2- burn only in contact with heat resource or hot fluids
3- burn area between 1- 10%
4-less than 6 hours passed from burning occurrence
5-patients with second degree burn
6- the wounds without any infection or trauma
7- burn only on body and/or extremities and not on head,neck and genital area
Exclusion criteria:
1- burn wound damage during care
2- presence of underlying diseases such as anemia, diabetes, cardiovascular disease, malignancy and immune insufficiency;; need to consumption of immune supportive drugs; corticosteroids or chemotherapy
3- pregnancy
4- failure to cooperation.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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
Postal code
Approval date
2014-05-03, 1393/02/13
Ethics committee reference number
11/4267/د
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
Method of measurement
Daily Inspection of Reveal Complete Recovery Burn Sore with Researcher and confirm with Specialist
Secondary outcomes
1
Description
Side effects such as allergy or redness
Timepoint
Daily
Method of measurement
Daily Inspection of Reveal Complete Recovery Burn Sore with Researcher and confirm with Specialist
Intervention groups
1
Description
Intervention group: after cleaning wound with aseptic N/S 0.9 %, wound has been placed in air until drying completely. Then, 3mm of Sea buckthorn ointment will rubbed on the wound, daily, by tongue blade and has been dressing with sterile Gauze. Dressings will changed daily until wound recovered completely.
Category
Treatment - Drugs
2
Description
Control group: 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 will rubbed on the wound, daily, by tongue blade and has been dressing with sterile Gauze. Dressings will changed daily until wound recovered completely.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Burn Clinic of Imam Mousa Kazem Hospital
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research, Isfahan University of Medical Sciences and Health Services
Full name of responsible person
Dr Mehdi Nematbakhsh
Street address
Research Vice Chancellor Isfahan University of Medical Sciences and Health Services
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research, Isfahan University of Medical Sciences and Health Services
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
Isfahan Nursing Faculty
Full name of responsible person
Reza Dariabeigi
Position
Faculty member, Isfahan Nursing Faculty
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences and Health Services, Hezarjarib street, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3792 7551
Fax
Email
daryabeigi@nm.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing Faculty of Isfahan
Full name of responsible person
Saeid Shafiee
Position
Msc Nursing
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences and Health Services, Hezarjarib street, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3457 2219
Fax
Email
s_shafiee@nm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan Nursing Faculty
Full name of responsible person
Saeid Shafiee
Position
MSc Nursing
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences and Health Services, Hezarjarib street, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3457 2219
Fax
Email
s_shafiee@nm.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)