Treating wound caused by elective cesarean section using a new formulation compose of probiotic lysate in chitosan nano gel base
Design
Clinical trial with control group، parallel groups with 30 person per group, double blind and randomized with a random number table.
Settings and conduct
The study is being carried out at Hazrat Zeinab Hospital in Shiraz. After surgery, the patient applies the topical product on her wound twice daily, and the physician examines the relevant variables on days 0, 3, 7, 10, and 12. In this study, physician, researcher and patient are not aware of the type of product received.
Participants/Inclusion and exclusion criteria
Level of education should be at least fifth grade elementary school,The pregnancy period is between 37-42weeks, don't have history of more than two cesareans and don't have drug sensitivity
Intervention groups
The intervention groups in this study will be probiotic based on chitosan nanogels, chitosan nanogels alone and the group receiving placebo.
Main outcome variables
The main variables studied in this study include redness, swelling, ecchymosis, discharge and wound area.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130514013321N2
Registration date:2020-05-17, 1399/02/28
Registration timing:prospective
Last update:2020-05-17, 1399/02/28
Update count:0
Registration date
2020-05-17, 1399/02/28
Registrant information
Name
Ahmad Gholami
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1242 4255
Email address
gholami@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical study of wound healing caused by elective cesarean section using probiotic lysate in chitosan nano-gel base.
Public title
The effect of probiotic on wound healing.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The level of education should be at least a fifth-grade elementary school. The pregnancy period is between 37-42 weeks.
The pregnancy period is between 37-42 weeks.
Exclusion criteria:
History of more than two cesareans.
BMI of more than 35.
Drug sensitivity.
Age
From 20 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Balanced block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
The control and intervention groups were randomly selected.
The physician gives the medicine to the patients randomly.
The researcher does not know about each group until after the analysis.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Floor 7, Vice chancellor of research and technology, Shiraz University of medical sciences, Zand bIvd
City
Shiraz
Province
Fars
Postal code
Approval date
2020-05-05, 1399/02/16
Ethics committee reference number
IR.SUMS.REC.1399.238
Health conditions studied
1
Description of health condition studied
Wound cause by elective cesarean section
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Investigation of wound swelling
Timepoint
Before intervention, days 10, 7, 3 and 12
Method of measurement
See by a gynecologist
2
Description
Evaluation of Wound Ecchymosis
Timepoint
Before intervention, days 10, 7, 3 and 12
Method of measurement
See by a gynecologist
3
Description
Evaluation of Wound discharge
Timepoint
Before intervention, days 10, 7, 3 and 12
Method of measurement
See by a gynecologist
4
Description
Check the extent of the wound
Timepoint
Before intervention, days 10, 7, 3 and 12
Method of measurement
See by a gynecologist
5
Description
Evaluation of wound redness
Timepoint
Before intervention, days 10, 7, 3 and 12
Method of measurement
See by a gynecologist
Secondary outcomes
empty
Intervention groups
1
Description
Control group: placebo
Category
Placebo
2
Description
Intervention group: Get Probiotics lysate 1% Prepared on chitosan nanogel base twice daily for 12 Days
Category
Treatment - Drugs
3
Description
Intervention group: Get Chitosan nano-gel product without probiotic twice daily for 12 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Zeinab hospital
Full name of responsible person
Navid Omidifar
Street address
Crossroads of Defaemoghaddas
City
Shiraz
Province
Fars
Postal code
7153813311
Phone
+98 71 3726 5443
Email
omidifarn@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Younes Ghasemi
Street address
Rokn Abad, Karafarin St
City
Shiraz
Province
Fars
Postal code
134814336
Phone
+98 71 3242 4127
Email
Ghasemiy@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Ahmad Gholami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Rokn Abad, Karafarin St
City
Shiraz
Province
Fars
Postal code
713451583
Phone
+98-711-2425305 (214)
Email
gholami@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ahmad Gholami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Rokn Abad, Karafarin St
City
Shiraz
Province
Fars
Postal code
713451583
Phone
+98-711-2425305 (214)
Email
gholami@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ahmad Gholami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Rokn Abad, Karafarin St
City
Shiraz
Province
Fars
Postal code
713451583
Phone
+98-711-2425305 (214)
Email
gholami@sums.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
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