Delay or failure in wound healing and cesarean scar is the most common complications after caesarean section. In this study, we examined the effect of Honey on wound healing and prevention of cesarean scar in women referred to the Ayatollah Taleghani Center of Arak in 2008-2010. This research is a randomized double blind controlled trial. Sample size in each group is 40 cases. Mothers were randomly allocated into one of three groups (honey, placebo, or control group without any intervention). Medication was used twice a day for 16 consecutive days. The group without any intervention did not receive any topical medication. On 10th day after the caesarean section, place of sutures for wound healing was evaluated based on the criteria in the scale "reeda" and then stitches were removed. After 40 days, sutures were assessed regarding wound cesarean section scar based on "Vancouver Scale".
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138802051845N1
Registration date:2010-05-29, 1389/03/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-05-29, 1389/03/08
Registrant information
Name
Tooba Heidari
Name of organization / entity
Arak university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 86141735039
Email address
t_heidari@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research of Arak University of Medical Sciences, Barij essense Company
Expected recruitment start date
2008-12-21, 1387/10/01
Expected recruitment end date
2010-08-23, 1389/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of honey on wound healing and scar of cesarean
Public title
Honey and cesarean wound
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age between 35-17, level of education the mother not less than five grade, gestational age between 37 to 42 weeks based on the first day since the last menstrual period (LMP) or ultrasound, cesarean delivery, uterine incision and lower transverse incision Faneshtyl skin, maximum two previous deliveries
Exclusion criteria: previous cesarean section, previous surgery in the lower abdominal area (site of cesarean section), smoking (cigarettes, hookah), known history of medical conditions known to have interaction to wound healing (Systemic or chronic diseases, heart, kidney, liver, respiratory, coagulation, connective tissue, skin, thyroid, diabetes, anemia, cancer, infectious diseases, or psychological), consumption of medications known to have interaction to healing and scar formation (glucocorticoids, anticoagulations, immunosuppressives, broad spectrum antibiotics, antihistamins, calcium antagonists, chemotherapy and radiotherapy), obstetric problems (such as eclampsia, preeclampsia, placenta previa, placental abruptia, multiple gestation, chorioamniotitis, being impregnated with a liquid Meconium and poly Hydramnyvs), mental complications such as death of parents, spouse, child, separation from a spouse, serious differences with her husband, Major changes in life situation, severe financial problems during the past month
Age
From 17 years old to 35 years old
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Arak University of Medical Sciences
Street address
Arak University of Medical Science, Sardasht, Arak
City
Arak
Postal code
Approval date
2008-11-05, 1387/08/15
Ethics committee reference number
87-43-4
Health conditions studied
1
Description of health condition studied
wound and cesarean scar
ICD-10 code
O85, O92
ICD-10 code description
Complications predominantly related to the puerperium
Primary outcomes
1
Description
healing of cesarean wound
Timepoint
10th days after cesaren operation
Method of measurement
reeda scale
Secondary outcomes
1
Description
cesarean scar
Timepoint
40th days after cesarean operation
Method of measurement
vancouver scale
Intervention groups
1
Description
honey, local use, twice a day for 16 consecutive days
Category
Treatment - Drugs
2
Description
Placebo, local use, twice a day for 16 consecutive days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Taleghani Teaching Treatment Center
Full name of responsible person
Street address
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Science
Full name of responsible person
Vice-chancellor for Research, Arak University of Medical Sciences
Street address
Arak University of Medical Science , Sardasht, Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Science
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Barij essence Company
Full name of responsible person
Dr. Reza Bekhradi
Street address
Kashan, Barij essence Compan
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Barij essence Company
Proportion provided by this source
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
Arak University of Medical Science
Full name of responsible person
Tooba Heidari
Position
Ms
Other areas of specialty/work
Street address
Arak University of Medical Science, Sardasht, Arak
City
Arak
Postal code
Phone
+98 86141735035
Fax
Email
t_heidari@arakmu.ac.ir , heidari.m.831@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Tooba Heidari
Position
Ms
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Sardasht, Arak
City
Arak
Postal code
Phone
+98 86141735035
Fax
Email
t_heidari@arakmu.ac.ir , heidari.m.831@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Science
Full name of responsible person
Tooba Heidari
Position
Ms
Other areas of specialty/work
Street address
Arak University of Medical Science, Sardasht, Arak
City
Arak
Postal code
Phone
+98 86141735035
Fax
Email
t_heidari@arakmu.ac.ir , heidari.m.831@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)