The study aims to determine the effect of grape seed ointment on cesarean wound healing. In this doubeel blind randomized controlled clinical trial , women between 18-35 years of age with a gestational age of 37-42 weeks that are not allergic to grape seed ointment will be selected for the study ,and will be excluded if they do not use ointment regularly and as directed. The study will be conducted on 129 women referring to Vali-asr Hospital in Birjand for caesarian surgery who will be randomly assigned to three groups of grape seed ointment 5%, grape seed ointment 2.5% and placebo. A coded package of ointment will be given to the mothers, and they will be trained on how to use it; that is,having washed their hands thouroughly and while wearing disposable gloves, they are expected to rub the ointment as much as the tip of a finger on the stitched area and repeat the steps twice a day (12 hours ± 2) from the second day after the operation to the fifteenth day .Health care points will be taught to all mothers .on the fifth and twelfth days after cesarean section,the researcher will do the follow-up by phone.Cesarean wound healing will be measured by REEDA scale. in three stages: the second day after surgery, before treatment with ointments, eighth and sixteenth days after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014122220393N1
Registration date:2015-02-16, 1393/11/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-02-16, 1393/11/27
Registrant information
Name
Sima Soorgi
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3244 3046
Email address
sima.soorgi@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Making ointments 2.5 and 5% of grape seed and placebo ointment will be made by the pharmaceutical industry complex Dineh
Expected recruitment start date
2015-04-20, 1394/01/31
Expected recruitment end date
2015-09-21, 1394/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of grape seed ointment (Vitis Vinifera) on women cesarean wound healing
Public title
The effect of grape seed on wound healing
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers in 37-42 weeks of pregnancy -cesarean with beneath cut- 18 to 35 years of age - BMI in the range of 18/5-25 in early pregnancy - Single fetus – Iranian -no acute or chronic illness - no-disruptive healing (disease i.e Diabetes, kidney disease, anemia, liver disease, mental) –non-consumption of drugs and tobacco - non-use of drugs affecting wound healing(Glucocorticoids, anticoagulants, immunosuppressant drugs, antibiotics and chemotherapy) - non- allergy grape seed ointment
Exclusion criteria:
Unwillingness to continue cooperation – irregular ointment use and as directed - Complications arising from the use of grape seed ointment - Antibiotics change from the patient's routine - Wound infection
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
129
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
Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences in Ghaffari Street
City
birjand
Postal code
971785357
Approval date
2014-11-30, 1393/09/09
Ethics committee reference number
06-09-1393
Health conditions studied
1
Description of health condition studied
cesarean
ICD-10 code
O90.0
ICD-10 code description
Disruption of caesarean section wound
Primary outcomes
1
Description
Wound Healing
Timepoint
Days of 2, 8,16 after cesarean
Method of measurement
Reeda questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
A coded package of ointment will be given to the mothers, and they will be trained on how to use it; that is,having washed their hands thouroughly and while wearing disposable gloves, they are expected to rub the ointment as much as the tip of a finger on the stitched area and repeat the steps twice a day (12 hours ± 2) from the second day after the operation to the fifteenth day .Health care points will be taught to all mothers .on the fifth and twelfth days after cesarean section,the researcher will do the follow-up by phone.Cesarean wound healing will be measured by REEDA scale. in three stages: the second day after surgery, before treatment with ointments, eighth and sixteenth days after surgery. Early intervention will be performed by the researcher and subsequent interventions by the trained mother. The first stage will be carried out at the hospital, the second stage in the clinic and the third phase by the researcher at the research center of Birjand University of Medical Sciences
Category
Treatment - Drugs
2
Description
In placebo group, placebo ointment will use instead of grape seed ointment.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali-asr Hospital
Full name of responsible person
Ali Mohammad izadpanah
Street address
School of Nursing & Midwifery Ghaffari Street
City
birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Ali Mohammad izadpanah
Street address
Ghaffari Street
City
birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
sima.soorgi
Position
msc student in nursing
Other areas of specialty/work
Street address
No29,Narang 2.1 Alley,Avinne Ave,Birjand
City
birjand
Postal code
9717433693
Phone
+98 56 3234 0109
Fax
Email
sima.soorgi@bums.ac.ir
Web page address
www.bums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Ali Mohammad Izadpanah
Position
Faculty member
Other areas of specialty/work
Street address
Ghaffari Street
City
birjand
Postal code
971785357
Phone
+98 56 3244 3042
Fax
Email
izadpanahy@bums.ac.ir
Web page address
www.bums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
sima soorgi
Position
msc student in nursing
Other areas of specialty/work
Street address
No29,Narang 2.1 Alley,Avinne Ave,Birjand
City
birjand
Postal code
9717433693
Phone
+98 56 3234 0109
Fax
Email
sima.soorgi@bums.ac.irsima.kia30@yahoo.com
Web page address
www.bums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)