Trial no.:	PACTR202111568106591	Date of Registration:	29/11/2021
Trial Status:	Registered in accordance with WHO and ICMJE standards

TRIAL DESCRIPTION

Public title

Efficacy of surgical excision and subdermal injection of triamcinolone acetonide for treatment of keloid scars after caesarean section

Official scientific title

Efficacy of surgical excision and subdermal injection of triamcinolone acetonide for treatment of keloid scars after caesarean section

Brief summary describing the background and objectives of the trial

Wound healing is a process consists of phases of inflammation, granulation tissue formation and tissue remodeling, and results in tissue structure integrity and damage being restored(.1) Abnormal wound healing can lead to keloids, which are benign dermal fibroproliferative nodular lesions that tend to recur after excision. Keloid scars arise from skin trauma or inflammation and may develop years after the initial insult and rarely regress. (2) Keloid scars represent 10–15% of all wounds. They can appear anywhere on the body and can last for years after the initial injury. (3) risk factors of keloid scars are usually patients younger than 30 years and have darker skin. Darkly pigmented skin is the primary risk factor for keloids, which has a 15–20-fold increased risk due to melanocyte-stimulating hormone anomalies. Black, Hispanic and Asian persons are more likely to develop keloid scars than Caucasians. Keloid scars are usually associated with pain and pruritis and severe emotional distress. (4) Keloid scars have negative feedback on the mental health during the post-natal period and can contribute to negative body image, and symptoms of depression. Patients with keloid scars have been reported to be sad with their scar. (5-8) Consequently, this can affect the communication skills, personal relationships and work of the patients and result in these patients being unsociable. (8) Based on the cellular mechanism of keloid formation, one of the first-line options to treat keloid scars is corticosteroid injection into the affected area. The steroids have both direct anti-inflammatory and vasoconstrictive effects. Administration of corticosteroids results in the whitening of keloid scars, suggesting a decrease of blood flow in the scar due to vasoconstriction. (9) There is also another treatment of keloid scar is surgical removal of the scar. However, since surgical removal of the keloid usually only provides temporary cosmetic relief and invariability followed by even

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

15/12/2021

Actual trial start date

Anticipated date of last follow up

15/12/2022

Actual Last follow-up date

Anticipated target sample size (number of participants)

54

Actual target sample size (number of participants)

Recruitment status

Active, not 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	Care giver/Provider,Outcome Assessors,Participants

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Control Group	control group	at surgery	6 weeks	surgical excision and saline injection	27	Placebo
Experimental Group	study group	surgical excision and triamcinolone injection will be done	6 weeks	riamcinolone acetone will be injected sub-dermally at the time of wound closure. Two ampules of triamcinolone acetonide will be administered at a single dose; each ampule 10 mg/1 ml active medication. The surgeon will inject one ampule along the entire length of the upper edge of the skin incision and one ampule along the entire length of the lower edge of the skin incision, using a 25 G needle.	27

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
age between18–45 years old; (2) being pregnant at the time of recruitment; (3) presence of a keloid scar from a previous caesarean section; ( 4) planned caesarean section for the current pregnancy. Women of all ethnicities with a keloid scar following a previous caesarean section will be eligible to participate in the study.	having a previous caesarean section with no keloid scar.	Adult: 18 Year(s)-44 Year(s)	18 Year(s)	45 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

25/01/2021

research ethics committee

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

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	To determine efficacy of Surgical excision and subdermal injection of triamcinolone acetonide for prevention of keloid scars after caesarean section . 2- To asses side effects of the surgical excision and subdermal injection of triamcinolone acetonide at the time of caesarean section (recent scar)	6 weeks after delivery
Secondary Outcome	To evaluate the effect of surgical excision and subdermal injection of triamcinolone acetonide on symptoms of depression in women with keloid scars . 2-To investigate patients ‘satisfaction with the treatment and their perception with the changes in their keloid scar after surgical excision and subdermal injection of triamcinolone acetonide .	6 weeks after delivery

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

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
sara elsayed	ring road, kilo 4.5	ismailia		Egypt

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

COLLABORATORS
Name	Street address	City	Postal code	Country
sara elsayed	ring road, kilo 4.5	ismailia		Egypt
radwa mohamed	ring road, kilo 4.5	ismailia		Egypt
omima tharwat	ring road, kilo 4.5	ismailia		Egypt
zakia mahdy	ring road, kilo 4.5	ismailia		Egypt

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	sara elsayed	Saraelsayed181@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	data sharing will be after approval of the research ethics committee and when required	Study Protocol	after study completion	when required and after approval of the 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