Objectives: cleft lip is a congenital disorder in which prompt repair and scar prevention together can result in early improvement and thus give reassurance to the parents. Honey as a cheap and accessible natural material can be used to dress wounds in these patients.
Method: forty children with cleft lip who had undergone surgical management were selected.
After surgical repair a tube containing sterile gel (honey or placebo) were given to parents to apply on the wound. Placebo was carbomer 953 which is indistinguishable from honey and has no good or bad effect on the wound.
Participants: patients with bilateral and unilateral cleft lip were included. Any disorder which could result in wound improvement delay and children with metabolic disease were excluded from the study.
Interventions: All patients in both groups were on antibiotics post surgery and this study did not deprived subjects from routine treatments. Honey or placebo was applied to the wound as a thin layer three times a day for a two week period.
The used honey was the Iranian honey from Azerbaijan territory which was reproduced as a Gel by the second author in Tabriz pharmacy school. Considering the probable Clostridium botulinum infection, the honey was sterilized with radiation by Tehran atomic energy organization and tested for quality control after radiation.
The primary result: patients’ wound was examined on 1st, 2nd, 7th, 14th, 21st and 30th day after surgery and relevant data such as color, shape, size and amount of scar formation was recorded
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014030316809N1
Registration date:2014-07-30, 1393/05/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-07-30, 1393/05/08
Registrant information
Name
Shahin Abdollahifakhim
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41152622507
Email address
abdollahifakhim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Pharmaceutical Research Center, Tabriz University of Medical Sciences
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2013-09-23, 1392/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of honey on wound healing and prevention of surgical site infection in patients with cleft lip
Public title
The effect of honey on wound healing and prevent infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Isolated unilateral or bilateral cleft lip
2- Non genetic syndromes
3- Non Cyanotic congenital heart disease, severe respiratory disease, kidney disease and other disorders affecting the wound healing process
Exclusion criteria:
1- Splitting wounds due to trauma
4- Severe Infectious disease (sepsis)
5- Severe malnutrition
6- Allergy to Honey
Age
From 1 year old to 2 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)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
non
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
University St.
City
Tabriz
Postal code
5136735886
Approval date
2013-08-22, 1392/05/31
Ethics committee reference number
5/4/4478
Health conditions studied
1
Description of health condition studied
Effectiveness of honey in wounds repairing process
ICD-10 code
Q36.9
ICD-10 code description
Cleft lip NOS
Primary outcomes
1
Description
Surgical Wound infection of Cleft Lip Repair
Timepoint
2 weeks after intervention
Method of measurement
Clinical assessment
2
Description
Surgical Wound healing of Cleft Lip Repair
Timepoint
two weeks after intervention
Method of measurement
clinical assessment
Secondary outcomes
empty
Intervention groups
1
Description
Applied honey was Iranian pure honey from Azarbaaijan region, which was prepared as a gel by second author in college of pharmacy, Tabriz University of medical science. In this project, due to the possibility of Clostridium botulinum in honey, radiation was done for sterilization of honey with keep useful material in Tehran's atomic energy agency after determining the dose of radiation and after assuring the quality of the honey, Re-examined by the appropriate agency. For two weeks, three times a day with sterile honey applied as a thin layer on the suture site.
Category
Treatment - Other
2
Description
We used Carbomer 953 as a Placebo that looks like honey and had no beneficial or detrimental effect on ulcers and are filled similar tubes and for two weeks, three times a day with sterile the placebo applied as a thin layer on the suture site.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Children Hospital of Tabriz University of Medical Sciences
Full name of responsible person
Shahin Abdollahifakhim
Street address
University St.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Office of the Vice Chancellor for Research (VCR) of Tabriz University of Medical Sciences
Full name of responsible person
Mahdi Farhoudi
Street address
University St.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Office of the Vice Chancellor for Research (VCR) of Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Shahin Abdollahifakhim
Position
Assistant Professor of ENT
Other areas of specialty/work
Street address
University St.
City
Tabriz
Postal code
5136735886
Phone
+98 984115262250
Fax
+98 984115262279
Email
Abdollahifakhim@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Shahin Abdollahifakhim
Position
Assistant Professor of ENT
Other areas of specialty/work
Street address
University St.
City
Tabriz
Postal code
5136735886
Phone
+98 41 1526 2251
Fax
+98 984115262279
Email
Abdollahifakhim@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Kayvan Akhtarkavan
Position
Resident of ENT
Other areas of specialty/work
Street address
University St.
City
Tabriz
Postal code
5136735886
Phone
+98 984113347054
Fax
+98 984113352073
Email
kayvan.kavan@gmail.com
Web page address
..
Sharing plan
Deidentified Individual Participant Data Set (IPD)