Trial no.:	PACTR201909687336867	Date of Registration:	25/09/2019
Trial Status:	Registered in accordance with WHO and ICMJE standards

TRIAL DESCRIPTION

Public title

Cosmetic results after different methods of subcutaneous tissue and skin closure in cesarean section in obese women: a randomized clinical trial

Official scientific title

Cosmetic results after different methods of subcutaneous tissue and skin closure in cesarean section in obese women: a randomized clinical trial

Brief summary describing the background and objectives of the trial

Caesarean section (CS) is the most commonly reported abdominal operation performed all over the world. The scar is the main patients' concern representing the only visible stigmata after CS. Wound complications affect 5% of women undergoing CS. These include hematomas, seromas or infection that may lead to wound dehiscence. One of the risk factors that have a major direct effect on these results is obesity. Previous studies reported that increased thickness of the subcutaneous tissue > 3 cm was associated with a relative risk of developing wound infection of 2.8. Also others found that rates of wound complications increase with increased body mass index (BMI) . The aim of the study is to evaluate the effect different methods of subcutaneous fat and skin closure on the cosmetic results in cesarean sections.

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

Pregnancy and Childbirth

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Prevention

Anticipated trial start date

01/08/2019

Actual trial start date

Anticipated date of last follow up

01/08/2020

Actual Last follow-up date

Anticipated target sample size (number of participants)

180

Actual target sample size (number of participants)

Recruitment status

Recruiting

Publication URL

Secondary Ids	Issuing authority/Trial register

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously	Randomised	Simple randomization using a randomization table created by a computer software program	Sealed opaque envelopes	Masking/blinding used	Participants

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Control Group	prolene group	closure and non-closure of the subcutaneous tissue	6 months after the cs	prolene group	90	Active-Treatment of Control Group
Experimental Group	vicryl group	closure and no- closure of the subcutaneous tissue	6 month ofter cs	vicryl group	90

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
Patients age 18-45 years, Patients with previous CS, Patients' BMI ≥ 30 kg/m2.	a) Clinical signs of chorioamnionitis at the time of CS, b) HELLP syndrome or preeclampsia, c) History of keloid scar formation, d) Medical disorders that could affect wound healing( known hypersensitivity to any of the suture materials used in the study, diabetes mellitus, chronic corticosteroid use or immunosuppression) e) Emergency CS, f) History of ruptured membranes before CS and g) Patients refusing to participate in the study.	Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s)	19 Year(s)	44 Year(s)	Female

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

22/07/2019

research ethics committee faculty of medicine suez canal university

Ethics Committee Address
Street address	City	Postal code	Country
ring road kilo 4.5	ismailia	41522	Egypt

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	effect pf different closure methods on the appearance of the scare 6 months after cs	6 months after cs
Secondary Outcome	complications related to the scare	6 weeks after cs

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
faculty of medicine suez canal university	ring road kilo 4.5	ismailia		Egypt

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
omima tharwat taha	ring road kilo 4.5	ismailia		Egypt

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	faculty of medicine suez canal university	ring road kilo 4.5	ismailia		Egypt	University

COLLABORATORS
Name	Street address	City	Postal code	Country
omima tharwat taha	ring road kilo 4.5	ismailia		Egypt
hanan mohamed ghoneim	ring road kilo 4.5	ismailia		Egypt

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	hanan ghoneim	hananghoneim@gmail.com	01223423685	ring road kilo 4.5
City	Postal code	Country	Position/Affiliation
ismailia		Egypt	suez canal university
Role	Name	Email	Phone	Street address
Public Enquiries	omima taha	omimatharwat@yahoo.com	01223423685	ring road kilo 4.5
City	Postal code	Country	Position/Affiliation
ismailia		Egypt	suez canal university
Role	Name	Email	Phone	Street address
Scientific Enquiries	omima taha	omimatharwat@yahoo.com	01223423685	ring road kilo 4.5
City	Postal code	Country	Position/Affiliation
ismailia		Egypt	suez canal university

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	sharing data through published manuscript after approval of our research ethics committee	Study Protocol	after completion if the trial	after approval of our research ethics committee
URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date
	No
Result Upload 1:	Result Upload 2:	Result Upload 3:	Result Upload 4:	Result Upload 5:

Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information

Pan African Clinical Trials Registry