Comparison of the effect of desellar amniotic membrane with wound debridement and its secondary closure on cesarean section wound infections(a Clinical Trials)
Comparison of the effect of desellar amniotic membrane with wound debridement and its secondary closure on cesarean section wound infections
Design
This is a randomized clinical trial study with a parallel design. This study is randomized, phase 2-3 study will be performed on 32 women undergoing cesarean section and referred to Imam Reza (AS) Hospital in 2020-2021 with a confirmed infection at the wound site. Simple random method are used for randomization and participants are assigned to two intervention groups.
Settings and conduct
This study, which will be performed in Imam Reza Hospital in Kermanshah, is non-blinded one. The amniotic membrane is transferred to the laboratory in the cold box
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients whose HIV test is negative; Informed consent
Exclusion criteria:Patients with the positive hepatitis B and C test
Intervention groups
In the first intervention group, desensitized amniotic membrane is used which contains proteins, growth factors, and a matrix of the basal and decellularized membrane without any cell formation and pathogenesis. In the second intervention group, live and non-living tissue was separated from the wound in the operating room. If the debridement wound bleeds, the growth factor is released from the end of the released platelets and stimulates wound healing, in that case, the wound in the operating room will be closed again by a gynecologist. For both groups, 2 g of cefazolin, 50 mg of ranitidine, and 10 mg of metoclopramide for 10 days are administered intravenously in the morning until the fever has subsided.
Main outcome variables
Wound healing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N186
Registration date:2022-06-01, 1401/03/11
Registration timing:prospective
Last update:2022-06-01, 1401/03/11
Update count:0
Registration date
2022-06-01, 1401/03/11
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-04, 1401/03/14
Expected recruitment end date
2023-02-03, 1401/11/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of desellar amniotic membrane with wound debridement and its secondary closure on cesarean section wound infections(a Clinical Trials)
Public title
The effect of de sellar amniotic membrane on cesarean section wound infections
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients whose HIV test is negative
Informed consent
Exclusion criteria:
Patients with the positive hepatitis B and C test
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random method. 32 cards are selected and numbers from 1-32 are inserted on the cards. The cards are placed in an envelope. Two of the design partners take one card out of the envelope each time and announce the card number. Paired numbers are assigned to the intervention group and odd numbers to the control group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2022-03-13, 1400/12/22
Ethics committee reference number
IR.KUMS.MED.REC.1401.022
Health conditions studied
1
Description of health condition studied
cesarean
ICD-10 code
O90.0
ICD-10 code description
Disruption of cesarean delivery wound
Primary outcomes
1
Description
Wound healing
Timepoint
The first 48 hours and 7 days after the intervention
Method of measurement
By a doctor
Secondary outcomes
empty
Intervention groups
1
Description
In the first intervention group, desensitized amniotic membrane is used which contains proteins, growth factors, and a matrix of the basal and decellularized membrane without any cell formation and pathogenesis. 2 g of cefazolin, 50 mg of ranitidine, and 10 mg of metoclopramide for 10 days are administered intravenously in the morning until the fever has subsided.
Category
Treatment - Other
2
Description
In the second intervention group, live and non-living tissue was separated from the wound in the operating room. If the debridement wound bleeds, the growth factor is released from the end of the released platelets and stimulates wound healing, in that case, the wound in the operating room will be closed again by a gynecologist. 2 g of cefazolin, 50 mg of ranitidine, and 10 mg of metoclopramide for 10 days are administered intravenously in the morning until the fever has subsided.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Valiyeh Mohammadi
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
Milad67669798@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Reza Khodarahmi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
rkhodarahmi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Valiyeh Mohammadi
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
Milad67669798@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Nasrin Jalilian
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
njalilian@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Valiyeh Mohammadi
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
Milad67669798@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD