The aim of this study is to evaluation the efficacy of platelet rich plasma in wound healing on women undergoing elective Cesarean Section Surgery. This is a non-randomized clinical trial, without using placebo or blinding the procedures. This study is in Arash hospital center (one center).The intervention arm receives autologous Platelet Rich Plasma. The control arm do not receive any wound treatment. All pregnant women candidate for elective Cesarean Section with Hemoglobin over 12 and without Diabetes or Gestational Diabetes are included in this study. The sample size of both arms in this study is 30 women. Fifteen patients candidates for elective Cesarean Section will receive autologous Platelet Rich Plasma (PRP) as intervention, only once during surgery on wound area. Platelet Rich Plasma (PRP) is produced from 60 cc of women autologous blood in surgery ward. The other patients are in control arm. The primary outcome is wound healing. Wound healing was checked in 5, 56 and 90 days after surgery by observational QUARTILE GRADING SCALE (QRS) method.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014041317251N1
Registration date:2014-04-30, 1393/02/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-30, 1393/02/10
Registrant information
Name
Negar Rezaei
Name of organization / entity
High Institute for Research and Education in Transfusion Medicine
Country
Iran (Islamic Republic of)
Phone
+98 21 8860 1564
Email address
n.rezaei@ibto.ir
Recruitment status
Recruitment complete
Funding source
High Institute for Research and Education in Transfusion Medicine
Expected recruitment start date
2011-11-22, 1390/09/01
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation The Efficacy of Platelet Rich Plasma in Wound Healing on Women Undergoing Elective Cesarean Section Surgery in Arash Women Hospital
Public title
Efficacy of Platelet Rich Plasma in Wound Healing on Women Undergoing Elective Cesarean Section Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion:all candidate women for elective surgery referred to Arash Women Hospital
exclusion: Positive history of diabetes; Gestational Diabetes in this pregnancy; Gestational Diabetes in previous pregnancies;Twin pregnancies; Hemoglobin under 12;Body Mass Index over 25; Smokers.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This is a pilot study .
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
High Institute for Research and Education in Transfusion Medicine
Street address
IBTO Building, Next to Milad Tower, Hemmat Exp.way
City
Tehran
Postal code
14665-1157
Approval date
2011-05-02, 1390/02/12
Ethics committee reference number
پ/103 مورخ 24/2/90
Health conditions studied
1
Description of health condition studied
wound healing
ICD-10 code
O90.0
ICD-10 code description
Disruption of caesarean section wound
Primary outcomes
1
Description
wound healing
Timepoint
5 days- 8 weaks-3 months
Method of measurement
QUARTILE GRADING SCALE(QRS) which is an observational method
Secondary outcomes
empty
Intervention groups
1
Description
intervention: After receiving 50- 60 CC of women blood in surgery ward, Platelet Rich plasma will be produce by Centrifuging the blood. Platelet Rich plasma is using once during the surgery on wound area .
Category
Treatment - Other
2
Description
control: there is no additional treatment for wound healing in this group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash Women Hospital
Full name of responsible person
Dr Rezaei
Street address
Next to Police Station Code:126, Shahid Baghdarnia St., Resalat Highway
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
High Institute for Research and Education in Transfusion Medicine
Full name of responsible person
DR krimi
Street address
IBTO Building, Next to the Milad Tower, Hemat Exp.way
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
High Institute for Research and Education in Transfusion Medicine
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
High Institute for Research and Education in Transfusion Medicine
Full name of responsible person
Dr Negar Rezaei
Position
Research Assistant In Charge, Medical Doctor
Other areas of specialty/work
Street address
IBTO Building, Next to the Milad Tower, Hemat Exp.way
City
Tehran
Postal code
146651157
Phone
+98 21 8860 1564
Fax
+98 21 8806 0717
Email
n.rezaei@ibto.ir;n.rezaei81@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
High Institute for Research and Education in Transfusion Medicine
Full name of responsible person
Dr Negar Rezaei
Position
Medical Doctor
Other areas of specialty/work
Street address
IBTO Building, Next to the Milad Tower, Hemat Exp.way
City
Tehran
Postal code
146651157
Phone
+98 21 8860 1564
Fax
Email
n.rezaei@ibto.ir; n.rezaei81@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
High Institute for Research and Education In Transfusion Medicine
Full name of responsible person
Dr Negar Rezaei
Position
Research Assistant In Charge, Medical Doctor
Other areas of specialty/work
Street address
IBTO Building, Next to the Milad Tower, Hemat Exp.way
City
Tehran
Postal code
146651157
Phone
+98 21 8860 1564
Fax
+98 21 8806 0717
Email
n.rezaei@ibto.ir;n.rezaei81@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)