Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000984291
Ethics application status
Approved
Date submitted
31/05/2018
Date registered
12/06/2018
Date last updated
17/05/2019
Date data sharing statement initially provided
17/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of Steroid Injection for Treatment of Caesarean Section Keloid Scars
Scientific title
Efficacy of Sub-dermal Injection of Triamcinolone Acetonide for Treatment of Caesarean Section Keloid Scars
Secondary ID [1] 295124 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Keloid scar 308105 0
Caesarean Section 308215 0
Condition category
Condition code
Skin 307143 307143 0 0
Dermatological conditions
Reproductive Health and Childbirth 307245 307245 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive surgical excision of keloid scar then sub-dermal injection of triamcinolone acetone at the time of wound closure after the delivery of the fetus. The excision of the scar and administration of the injection will be performed by the surgeon that is scheduled to perform the surgery on the day.
Two ampules of triamcinolone will be administered at a single dose, Each ampule contains 10mg/1ml active medication. We will inject one ampule in the upper edge of the wound and one ampule in lower edge of the wound.
All the surgeons in the Department of Women's and Newborn Health will be trained on how to perform the excision and injection of the triamcinolone. The Principal Investigator of the study will assess the fidelity to the intervention by supervising procedures.

The patients will be reviewed on the ward post caesarean sections for any signs of complications until discharge. The patients will be given a phone number to call to contact the investigator in case of any reaction and complication in relation to the caesarean section scar. Advice would be given to patients over the phone or invited to present to hospital for review for further management.
There will be an independent data and safety monitoring committee that will be established by the head of the department of women’s and newborn health to assess at intervals the progress of the clinical trial, the safety data and the critical efficacy endpoints, and to recommend to the principal investigator whether to continue, modify or stop the clinical trial.
Intervention code [1] 301390 0
Treatment: Drugs
Comparator / control treatment
The control group will receive surgical excision of keloid scar then routine wound closure.
The routine wound closure is as follows: The uterus is closed in 2 layers followed by closure of rectus sheath all using continuous sutures with 1-Vicryl (J&J). The fat layer is closed with interrupted plain gut 2 cm apart. The skin layer is then closed with 3-0 Monocryl (Ethicon) in a subcuticular fashion.
The routine wound closure is in accordance with NICE guidelines,
Control group
Active

Outcomes
Primary outcome [1] 306098 0
Primary outcome is keloid formation in patients with a previous history of keloid caesarean scar.
The baseline information including measurement of the scar will be collected at time of the consent and /or around 36 weeks when patient is consented for the surgery. The scar will be photographed and measured for length and width in millimetre; elevation, hardness and erythema will be graded by the assessor on a 3-point scale. (0=None; 1=partial; 2= along entire scar). A subjective symptom score will be graded by patient’s for pruritus, pain and swelling on a 3-point scale (0=None; 1=occasionally; 2=all the time). Scar will be also be photographed.
Timepoint [1] 306098 0
6 weeks, 6 months and 1 year after the intervention
Primary outcome [2] 306099 0
There is a composite primary outcome including changes in the appearance and specification of the Keloid scar after the intervention.
The scar will be photographed and measured for length and width in millimetre; elevation, hardness and erythema will be graded by the assessor on a 3-point scale. (0=None; 1=partial; 2= along entire scar). A subjective symptom score will be graded by patient’s for pruritus, pain and swelling on a 3-point scale (0=None; 1=occasionally; 2=all the time). Scar will be also be photographed.
Timepoint [2] 306099 0
6 weeks, 6 months and 1 year after the intervention
Secondary outcome [1] 347565 0
Percentage of women with depression, anxiety and stress using the Depression, Anxiety and Stress Scale-21 (DASS-21)
Timepoint [1] 347565 0
6 weeks, 6 months and 1 year after the intervention
Secondary outcome [2] 348826 0
To evaluate patient's satisfaction with the treatment and changes in their keloid scar
Timepoint [2] 348826 0
6 weeks, 6 months and 1 year after the intervention

Eligibility
Key inclusion criteria
1. Presence of a keloid scar from a previous caesarean section
2. Planed caesarean section for this current pregnancy
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Primigravida
2. Previous caesarean section without keloid scar

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation will be concealed as it will be done by an independent researcher who works neither in the operating theatre nor in the clinic and will not know what the next treatment allocation will be.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Using the estimates from the study by Khalid et al.(2018), the intervention will increase the incidence of the efficacy of treatment for keloid scarring from 45% in the excision followed by radiation group to 70% in the excision followed by intralesional Triamcinolone acetonide and 5-flourouracil group. We calculated that a total of 150 patients (75 in each group) would have 80% power with a two-sided significance level of 5% to detect this difference between the groups. This allows for 10% non-compliance.

- Khalid F, Farooq U, Saleem M, Rabbani J, Amin M, Khan K, et al. The efficacy of excision followed by intralesional 5-fluorouracil and triamcinolone acetonide versus excision followed by radiotherapy in the treatment of ear keloids: A randomized control trial. Burns. 2018;44(6):1489-95.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/05/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2021
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11051 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 22847 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 295429 0
Hospital
Name [1] 295429 0
Westmead hospital
Country [1] 295429 0
Australia
Primary sponsor type
Hospital
Name
Westmead hospital
Address
Hawkesbury Rd, Westmead Hospital, Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 294249 0
None
Name [1] 294249 0
Address [1] 294249 0
Country [1] 294249 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296761 0
Western Sydney Local Health District Human Research Ethics
Ethics committee address [1] 296761 0
Westmead Hospital, Hawkesbury Rd, Westmead, NSW 2145
Ethics committee country [1] 296761 0
Australia
Date submitted for ethics approval [1] 296761 0
Approval date [1] 296761 0
25/06/2016
Ethics approval number [1] 296761 0
4103

Summary
Brief summary
Keloid scarring is one of the most difficult clinical problems in wound healing. It can dramatically affect a patient’s quality of life both physically and psychologically. A wide array of treatments has been used to treat keloid scars. Of these, intralesional injection of triamcinolone acetonide is most frequently used. We aim to evaluate the effectiveness of sub dermal injection of triamcinolone acetonide at the time of caesarean section to prevent keloid formation in patients with existing keloid caesarean section scar. This will be a randomized controlled clinical trial. All the patients with a previous caesarean section and presence of existing keloid scar will be included in the study. The patients will be randomized into two study groups. The control group will receive surgical excision of keloid scar then routine wound closure. The treatment group will receive surgical excision of keloid scar then sub-dermal injection of triamcinolone acetone at the time of wound closure after the delivery of the fetus. The patients are followed up for 5 days post operation for complications, then at 6 weeks, 6 months and 1 year post partum.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71982 0
Dr Seng Chai Chua
Address 71982 0
Room 3046, Research and Education Network (REN) Building,
Westmead Hospital, 9 Hawkesbury Rd, Westmead NSW 2145, Australia
Country 71982 0
Australia
Phone 71982 0
+61414937273
Fax 71982 0
Email 71982 0
drchuasc@gmail.com
Contact person for public queries
Name 71983 0
Dr Marjan Khajehei
Address 71983 0
Research and Education Network (REN) Building,
Westmead Hospital, 9 Hawkesbury Rd, Westmead NSW 2145, Australia
Country 71983 0
Australia
Phone 71983 0
+61437793398
Fax 71983 0
Email 71983 0
Marjan.Khajehei@health.nsw.gov.au
Contact person for scientific queries
Name 71984 0
Dr Seng Chai Chua
Address 71984 0
Room 3046, Research and Education Network (REN) Building,
Westmead Hospital, 9 Hawkesbury Rd, Westmead NSW 2145, Australia
Country 71984 0
Australia
Phone 71984 0
+61414937273
Fax 71984 0
Email 71984 0
drchuasc@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2125Study protocol    372231-(Uploaded-17-05-2019-11-14-27)-Study-related document.doc


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2125Study protocol https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6582563drchuasc@gmail.com 372231-(Uploaded-21-04-2021-11-48-51)-Study-related document.doc
23478Informed consent form  drchuasc@gmail.com
23479Clinical study report  drchuasc@gmail.com
23480Ethical approval  drchuasc@gmail.com
23481Statistical analysis plan  drchuasc@gmail.com
23482Analytic code  drchuasc@gmail.com

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEfficacy of surgical excision and sub-dermal injection of triamcinolone acetonide for treatment of keloid scars after caesarean section: A single blind randomised controlled trial protocol.2019https://dx.doi.org/10.1186/s13063-019-3465-6
N.B. These documents automatically identified may not have been verified by the study sponsor.