Protocol summary

Study aim
The aim of this study is to investigate the effect of autologous amniotic membrane and amniotic fluid on healing and complications of cesarean section wounds.
Design
A controlled, factorial, double-blind, randomized, phase 3 clinical trial on 244 patients who were divided into 4 groups using blocks of 4, 8, and 12.
Settings and conduct
The study setting is Arash Women's Hospital. After cesarean section, patients will receive one of 4 types of dressing based on the group they are placed in. Except for the external study observer and the surgical team performing the intervention, everyone else will be blinded.
Participants/Inclusion and exclusion criteria
Pregnant women candidates for caesarean section
Intervention groups
First intervention group: dressing using amniotic membrane. Second intervention group: dressing using amnion spray. Third intervention group: dressing with simultaneous use of amniotic membrane and amniotic spray. Control group: simple dressing.
Main outcome variables
Incidence of wound complications and surgical wound healing scores from the perspective of patient and doctor.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220408054454N1
Registration date: 2024-07-15, 1403/04/25
Registration timing: prospective

Last update: 2024-07-15, 1403/04/25
Update count: 0
Registration date
2024-07-15, 1403/04/25
Registrant information
Name
Amene Abiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 709 0424
Email address
abiri@sina.tums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2025-07-23, 1404/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of using autologous amniotic membranes and fluid on wound healing and complications of cesarean surgery: a factorial randomized clinical trial
Public title
Effect of amniotic membranes and fluid on cesarean surgery wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-45 years Singleton pregnancy Having a previous plan for cesarean section and elective cesarean section Planned gestational age of at least 36 weeks at the time of delivery Able to provide informed consent Intention to be available for the entire research period and to complete all relevant study steps, including follow-up visits and phone calls Hemoglobin above 10 g/dL at the time of hospitalization
Exclusion criteria:
Body mass index greater than or equal to 40 at the time of entering the study Placenta previa or placenta accreta History of intestinal or urological surgery Multiple pregnancy Known or suspected impairment of immunological function, including infection with HIV, hepatitis B or C Use of immunosuppressive drugs, chemotherapy, radiotherapy, or taking systemic corticosteroids in the 4 weeks before surgery. Known tobacco or drug use Any condition that, in the opinion of the investigator, may pose a risk to the health of the participant or interfere with the evaluation of the study objectives History of keloid formation Participation in another clinical trial in the last three months Any serious cardiovascular, pulmonary, hepatic, renal, digestive, hematologic, endocrine, metabolic, neurological and psychological diseases Frequent vaginal examinations Emergency cesarean section Chorioamnionitis or other systemic infections at the time of presentation for caesarean section, including evidence of subabdominal skin infection (e.g. fungal infection)
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 224
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization with block sizes of 4, 8, and 12 will be used. Using Stata 17.0 software, a list of random blocks with the mentioned sizes will be created randomly. Concealment will be done using sealed letters.
Blinding (investigator's opinion)
Double blinded
Blinding description
The wound dressings of all four groups are similar and due to the fact that the amniotic membrane is placed under the dressing, the patient will not be aware of her allocation. Blinding of the surgical team is not possible. The physician who examines the condition of the wound will not be aware of the participant's group, and the patient's wound dressing will be opened by another physician or nurse before the examination by the physician, so that the examining physician does not know about the participant's assignment. The statistical analyst and the interviewer who will have phone calls with the patient during the follow-up period will not know about her allocation. In total, except for the surgical team and the external observer, all people involved in the study will be blinded.
Placebo
Used
Assignment
Factorial
Other design features
None

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran university of Tehran
Street address
Arash hospital, Baqdarnia St., East Farjam St., Tehranpars
City
Tehran
Province
Tehran
Postal code
1653915981
Approval date
2024-03-13, 1402/12/23
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.758

Health conditions studied

1

Description of health condition studied
Cesarean surgical wound
ICD-10 code
O86.0
ICD-10 code description
Infection of obstetric surgical wound

Primary outcomes

1

Description
Wound healing score according to physician's point of view
Timepoint
On days 10 and 28 after surgery
Method of measurement
Using the The Patient and Observer Scar Assessment Scale: POSAS questionnaire

Secondary outcomes

1

Description
Severity of pain at the site of the surgical wound
Timepoint
4, 12, 24, and 36 hours after surgery and days 10 and 28 after surgery
Method of measurement
Visual Analogue Scale

2

Description
Surgical wound infection
Timepoint
4, 12, 24, and 36 hours after surgery and days 10 and 28 after surgery
Method of measurement
According to the doctor's diagnosis

3

Description
Wound healing score according to patient's point of view
Timepoint
On days 10 and 28 after surgery
Method of measurement
Using the The Patient and Observer Scar Assessment Scale: POSAS questionnaire

4

Description
Surgical wound infection
Timepoint
36 hours after surgery and days 10 and 28 after surgery
Method of measurement
According to the doctor's diagnosis

5

Description
Severity of pain at the site of the surgical wound
Timepoint
4, 12, 24, and 36 hours after surgery and days 10 and 28 after surgery
Method of measurement
Visual Analogue Scale

Intervention groups

1

Description
First intervention group: dressing with amniotic membrane. After the surgery, a part of the patient's amniotic membrane corresponding to the size of the surgical incision is removed and washed with sterile normal saline. The autologous amniotic membrane will be stored in a sterile receiver filled with sterile normal saline at all times between harvest and use. Then, the surgical incision is sutured in the usual way and after putting the amniotic membrane on the wound, it is bandaged. The amniotic membrane remains on the wound for 36 hours, after which it is removed and the dressing is changed.
Category
Treatment - Other

2

Description
The second intervention group: dressing with amniotic fluid spray. After cutting the abdominal layers, the amniotic membrane will be pierced with a perforator and the amniotic fluid will be extracted using a syringe. The syringe containing the amniotic fluid is then observed for contamination (for example, the presence of meconium). Then a sufficient amount of amniotic fluid is poured into the incision of the skin. At the end the incision is sutured and dressed as usual.
Category
Treatment - Other

3

Description
The third intervention group: dressing with amniotic fluid and membrane spray. The steps mentioned in the first and second intervention groups will be repeated simultaneously for this group.
Category
Treatment - Other

4

Description
Control group: conventional treatment (simple dressing). A simple dressing that is commonly used for cesarean surgery will be applied to the patient's cesarean wound.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Arash Women Hospital
Full name of responsible person
Ameneh Abiri
Street address
Resalat highway, after Shahid Bagheri highway, Shahid Baghdarnia street
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Email
abiri@sina.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari Sari
Street address
Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8163 3698
Email
vcr@sina.tums.ac.ir
Web page address
https://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Ameneh Abiri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
0098217719922
Email
abiri@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amene Abiri
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
َArash Hospital-Baqdarnia St.-East Farjam St.-Tehranpars
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 912 709 0424
Fax
Email
abiri@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amene Abiri
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
َArash Hospital-Baqdarnia St.-East Farjam St.-Tehranpars
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 912 709 0424
Fax
Email
abiri@sina.tums.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
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