The objective of this randomized double-blind clinical trial is to investigate the effect of topical application of honey on the scar of clean surgical wounds. All patients who referred to plastic surgery clinic, candidate for plastic surgery with clean surgical wounds will be enrolled, and exclusion criter will be systemic diseases or bee sting allergy history. 100 ulcers will randomly be divided into two groups. In any patient at least two surgical wound will be considered, one as intervention and another as control wound. Intervention group will be treated by topical honey and controls by Vaseline gauze alone, after wound closure in the end of operation. The dressing after 5 days will be removed. The rate of wound complication and healing time and scars will be compared in both groups by a plastic surgeon at 2 weeks and 3, 6 months post operation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102085781N1
Registration date:2011-10-04, 1390/07/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-10-04, 1390/07/12
Registrant information
Name
Ghasemali Khorasani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6643 8153
Email address
khorasani@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research, Tehran university of medical sciences
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-05-21, 1391/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of topical application of honey on the scar of clean surgical wounds
Public title
The effect of topical application of honey on the scar of wounds
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All Patients who are refered to the plastic surgery clinic, candidate for plastic surgery with clean surgical wounds. Exclusion criteria: All Patients with systemic diseases or bee sting allergy history.
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
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethics committee of Tehran University of Medical Sciences
Street address
Tehran university of medical sciences, Ghods Avenue, Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2011-05-22, 1390/03/01
Ethics committee reference number
1215
Health conditions studied
1
Description of health condition studied
plastic surgery induced wounds
ICD-10 code
Z41.1
ICD-10 code description
Other plastic surgery for unacceptable cosmetic appearance
Primary outcomes
1
Description
wound scar size
Timepoint
after 3, 6 months
Method of measurement
ruler
Secondary outcomes
1
Description
wound complications
Timepoint
after 2 weeks
Method of measurement
examination
Intervention groups
1
Description
In Intervention group:topical honey as dressing will be used, just after wound closure, and will be removed after 5 days.
Category
Treatment - Other
2
Description
In Intervention group: vaselin gauz as dressing will be used, after wound closure, and will be removed after 5 days.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital (Imam khomeini hospital complex)
Full name of responsible person
Ghasemali Khorasani
Street address
Bagherkhan Aven. Imam Khomeini hospital complex
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran university of medical university
Full name of responsible person
Dr.Akbar Fotouhi
Street address
Vice chancellor for research of Tehran university of medical sciences, 5th floor, Ghods Avenue, Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran university of medical university
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
Tehran University of Medical Sciences
Full name of responsible person
Ghasemali Khorasani
Position
associated professor
Other areas of specialty/work
Street address
The department of plastic surgery, Valiasr hospital, Emam Khomeini hospital
City
Tehran
Postal code
Phone
+98 21 6643 8153
Fax
Email
khorasani@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ghasemali Khorasani
Position
associated professor
Other areas of specialty/work
Street address
The department of plastic surgery, Valiasr hospital, Emam Khomeini hospital
City
Tehran
Postal code
Phone
+98 21 6643 8153
Fax
Email
khorasani@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ghasemali Khorasani
Position
associated professor
Other areas of specialty/work
Street address
The department of plastic surgery, Valiasr hospital, Emam Khomeini hospital
City
Tehran
Postal code
Phone
+98 21 6643 8153
Fax
Email
khorasani@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)