This study is designed to compare the effects of honey and mefnaid acetate in healing of grade 3 and 4 burn wounds on patients admitted in burn ward. One hundred patients are randomly assigned to intervention or control group. After admission and initial preparing and wound irrigation with normal saline, dressing with a layer of honey or mefnaid acetate on wound will be done twice daily, in the intervention and control group, respectively. Clinical improvement will be evaluated as the granulation tissue area by using visual analog scale on 7 and 21 day and one month after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201008144563N1
Registration date:2010-09-18, 1389/06/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2010-09-18, 1389/06/27
Registrant information
Name
Mohammad Baghaei
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1667 6780
Email address
baghaeim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Sina Educational and therapeutic center
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2011-02-20, 1389/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of honey and mefnaid acetate in healing of 3rd and 4th degree burn wounds
Public title
The effect of honey in healing of 3rd and 4th degree burn wounds
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: presence of 3rd and 4th degree burn wounds
Exclusion criteria: drug hypersensitivity, superficial burn wounds, involvement of more than over 20 percent of body surface area
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Vice-Chancellor for Research, Faculty of Medicine, Tabriz University of Medical Sciences,
Street address
Golgasht St.
City
Tababriz
Postal code
Approval date
empty
Ethics committee reference number
5.4.3059
Health conditions studied
1
Description of health condition studied
Burns
ICD-10 code
T30.3
ICD-10 code description
Burn of third degree, body region unspecified Third-degree burn NOS
Primary outcomes
1
Description
Area of granulation tissue
Timepoint
Before the intervention, one week, three weeks and one month after the intervention
Method of measurement
cm^2
Secondary outcomes
1
Description
Wound infection
Timepoint
One week, three weeks, one month and six months after the intervention
Method of measurement
Incidence of infection
2
Description
Scar
Timepoint
One week, three weeks, one month and six months after the intervention
Method of measurement
Visual analogue scale
Intervention groups
1
Description
Irrigation of wound will be performed every 12 hours with normal saline and then wound will be covered and dressed with a layer of honey with a dose of 1 inches per 5 square centimeter of wound surface area. Treatment duration will take three weeks.
Category
Other
2
Description
Irrigation of wound will be performed every 12 hours with normal saline and then wound will be covered and dressed with a layer of mefnaid acetate with a dose of 1 inche per 5 square centimeter of wound surface area. Treatment duration will take three weeks.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Men and women burn wards, Sina Educational and Thraputic Center
Full name of responsible person
Dr.Mohammad Baghaei
Street address
after Maralan intersection, Azadi St,
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sina Educational and Thraputic Center
Full name of responsible person
Dr. Hemmat Maghsoudi
Street address
After Maralan intersection, Azadi St,
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sina Educational and Thraputic Center
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
Sina Educational and Thraputic Center
Full name of responsible person
Dr. Hemmat Maghsoudi
Position
Assistant Professor, General Surgery
Other areas of specialty/work
Street address
Azadi St, after Maralan intersection
City
Tabriz
Postal code
Phone
+98 41 1541 2101
Fax
+98 41 1542 9060
Email
maghssoudih@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Men and women burn wards, Sina Educational and Thraputic Center
Full name of responsible person
Dr. Fereydoun Salehi
Position
Assistant Professor of Plastic and reconstructive surgery
Other areas of specialty/work
Street address
Azadi St, after Maralan intersection
City
Tabriz
Postal code
Phone
+98 41 1541 2101
Fax
Email
maghssoudih@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Medicine, Tabriz University of Medical Sciences and Health Services
Full name of responsible person
Dr. Mohammad Baghaei
Position
Assistant of general surgery
Other areas of specialty/work
Street address
beside Imam Reza Hospital, Daneshgah Sq, Golgasht St.
City
Tabriz
Postal code
Phone
+98 41 1541 2101
Fax
Email
dr.baghaei@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)