Determine the effect of flaxseed ointment on cesarean wound healing
Design
A double-blind clinical trial was conducted on 120 women who were selected using spss software and randomly assigned into three intervention groups (referee, placebo) and control.
Settings and conduct
120 women who are referred to Imam Reza Hospital for cesarean section are selected. For the first 24 hours after the cesarean section, the area of the wound is washed with the serum and washed out of the drug or placebo. Duration of ointment in both groups is twice daily for 8 days. The control group receives health recommendations according to the hospital protocol. One-four-eighty-four-day-olds are evaluated with the help of the Rida instrument and the visual scale of the pain. Researcher, statistical analyst and research units of the type of drug (drug, placebo).
Participants/Inclusion and exclusion criteria
Inclusion criteria
Age less than 18 years and more than 35 years
Gestational age less than 37 or more than 42 weeks
At least once previous cesarean section
delivery of cesarean section.
Baby weighing less than 2500 gr or over 4000 gr
Cesarean section with myomectomy or hysterectomy
Excessive bleeding that requires blood transfusion.
Anomalies manifest in the baby.
Extending the operating time for more than an hour
Damage to the bladder or abdominal aorta during cesarean section
Midwifery problems
Expansion of surgical
Cure for diseases that impair wound healing.
Problems like: death of parents, wife, baby.
Failure to enter the study
Do not use ointment for more than two days or 6 times dispersed
Drug effective on wound healing.
Intervention groups
Patient intervention groups or darunamar use 24 hours a day and then twice daily for 8 days daily. The health advice group is provided based on the routine protocol of the hospital.
Main outcome variables
Healing wound
Pain
General information
Reason for update
Acronym
MKC
IRCT registration information
IRCT registration number:IRCT20180506039552N1
Registration date:2018-10-25, 1397/08/03
Registration timing:registered_while_recruiting
Last update:2018-10-25, 1397/08/03
Update count:0
Registration date
2018-10-25, 1397/08/03
Registrant information
Name
Maryam Soleimani huni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3251 3806
Email address
soleimanihm951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of flaxseed ointment on cesarean wound healing
Public title
The effect of flaxseed ointment on cesarean wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1.Be Iranian. 2- Resident of Mashhad. 3. The willingness to cooperate in the research, 4-age less than 18 years and more than 35 years.5. Have at least a reading / writing literacy higher than fifth of elementary school. 6-Gestational age less than 37 or more than 42 weeks based on LMP or first trimester ultrasonography. 7- At least once a previous cesarean section. 8. Cesarean Delivery, 9. Classic Hysterotomy Siege. 10. Weight of a baby under 2500 g or over 4000 g. 11 - Live or dead baby 12 - Cesarean section with myomectomy or hysterectomy.13. Excessive bleeding requiring blood transfusion. 14. Significant abnormality in the baby. 15. Longevity of the operation for more than an hour. 16. Damage to the bladder or abdominal aorta during cesarean section. 17. Midwifery problems. 18-Development of surgical incision 19-Distribution of wound healing disorders. 20. Problems such as: the death of parents, spouse, infant.
Exclusion criteria:
1-Do not use ointment for more than 2 days or 6 times dispersed 2- Use of drugs effective on wound healing.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Using SPSS software
Blinding (investigator's opinion)
Double blinded
Blinding description
Drug and drug coding was done by one of the laboratory staff.
Placebo
Used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Mashhad University of Medical Sciences
Street address
st.Daneshgah,Crossroad.Doktura,st.Ebn Sina.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2018-07-03, 1397/04/12
Ethics committee reference number
IR.MUMS.NURSE.REC.1397.023
Health conditions studied
1
Description of health condition studied
Cesarean wound healing
ICD-10 code
090.0
ICD-10 code description
Disruption of caesarean section wound
Primary outcomes
1
Description
Wound healing
Timepoint
After cesarean section (24 hours) and 4th and 8th days after the caesarian section
Method of measurement
Reeda Scale
Secondary outcomes
1
Description
pain
Timepoint
After cesarean section (24 hours) and 4th and 8th days after the caesarian section
Method of measurement
Pain visual scale
Intervention groups
1
Description
Intervention group1: the research unit in the same area as a piece of 5% cotton linen ointment, so that it is completely applied to the surface and done daily twice a day (every 12 hours) for 8 consecutive days
Category
Treatment - Drugs
2
Description
Intervention group 2: the research units in the size of a cuff of the placebo ointment (the base of the ointment) on the suture area, so that it completely covers the surface of the wound and do this twice daily (every 12 hours) for 8 consecutive days It is prescribed.
Category
Placebo
3
Description
Control group: Control group do not receive any drugs; they just receive routine care. The researcher sees them on 5th and 10th days after the caesarian section surgery
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Naderi
Street address
Ebnesina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
emamreza@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mosen Tafaghodi
Street address
Ghoreshi building, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Phone
+98 51 3841 1538
Email
WWW.vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Robab Latifnejad
Position
Vice President of Research and Faculty of Nursing and Midwifery
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
School of Nursing and Midwifery, Ibn Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+51 38591511
Email
latifnejadr@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sedigheh Yousefzadeh
Position
Mashhad University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ebnesina Street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 1859 8016
Fax
+98 51 1859 7313
Email
yousefzadehs@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Soleimani
Position
Midwifery Master
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ebnesina Street, School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+51 38591511
Email
soleimanihm951@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available