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Trial registered on ANZCTR


Registration number
ACTRN12622000619741
Ethics application status
Approved
Date submitted
31/01/2022
Date registered
26/04/2022
Date last updated
22/10/2023
Date data sharing statement initially provided
26/04/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
The efficacy of adipose-derived stem cells as treatment of hypertrophic scar: a non-randomized controlled trial
Scientific title
The efficacy of adipose-derived stem cells as treatment of hypertrophic scar: a non-randomized controlled trial
Secondary ID [1] 306231 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertrophic scar 324957 0
Condition category
Condition code
Skin 322391 322391 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. The first treatment group will be hypertrophic scars receiving injections of adipose-derived stem cells (ASCs) suspended in ASC conditioned medium. The suspended ASCs will be injected into hypertrophic scar with a dose of 1,000,000 cells in 1 ml of medium for a 1x1 cm2 area of hypertrophic scar. This trial will target 1x1 cm2 - 3x3 cm2 area of hypertrophic scar. Injection will be conducted three times, with 7-10-day interval between each injections.
Injections will be done by a single doctor.
2. The second treatment group will be hypertrophic scars receiving injections of ASC conditioned medium without ASCs in it, with a dose of 1 ml of medium for a 1x1 cm2 area of hypertrophic scar. This trial will target 1x1 cm2 - 3x3 cm2 area of hypertrophic scar. Injection will be conducted three times, with 7-10-day interval between each injections.
Injection will be performed by the same doctor as the doctor in the first treatment group.

The volume of injections given will be recorded in a case report form and will be audited at the end of the study. The method of allocation used is consecutive allocation based on recruitment process following the order of: 7 subjects receiving ASC and 7 subjects receiving ASC conditioned medium.
Intervention code [1] 322635 0
Treatment: Other
Comparator / control treatment
The control group will be hypertrophic scars receiving triamcinolone acetonide 10 mg/mL (corticosteroid) injections with a dose of 1 mL of medium for a 1x1 cm2 area of hypertrophic scar. This trial will target 1x1 cm2 - 3x3 cm2 area of hypertrophic scar. Injection will be conducted three times, with 7-10-day interval between each injections.
Control group
Active

Outcomes
Primary outcome [1] 330167 0
POSAS (The Patient and Observer Scar Assessment Scale) Questionnaire
Timepoint [1] 330167 0
Right before biopsy 1; 2 weeks after biopsy 1 (right before injection 1); right before injection 2 (7-10 days after injection 1); right before injection 3 (7-10 days after injection 2); 7-10 days after injection 3; 3 weeks after injection 3, 3 months after injection 1 (right before biopsy 2); 2 weeks after biopsy 2
Primary outcome [2] 330168 0
Changes in histopathology structures of the scar tissue (a 3-mm punch biopsy will be performed on the area of scar and evaluated by a single pathologist)
Timepoint [2] 330168 0
2 weeks before injection 1 and 3 months after injection 1
Primary outcome [3] 330169 0
Thickness of scar tissue (evaluated with ultrasonography/USG)
Timepoint [3] 330169 0
2 weeks before injection 1 and 3 months after injection 1
Secondary outcome [1] 405102 0
Color of scar (evaluated with POSAS Questionnaire)
Timepoint [1] 405102 0
Right before biopsy 1, 2 weeks after biopsy 1 (right before injection 1), right before injection 2 (7-10 days after injection 1), right before injection 3 (7-10 days after injection 2), 7-10 days after injection 3, 3 weeks after injection 3, 3 months after injection 1 (right before biopsy 2), 2 weeks after biopsy 2
Secondary outcome [2] 405103 0
Elasticity of scar tissue (evaluated with durometer)
Timepoint [2] 405103 0
Right before biopsy 1, 2 weeks after biopsy 1 (right before injection 1), right before injection 2 (7-10 days after injection 1), right before injection 3 (7-10 days after injection 2), 7-10 days after injection 3, 3 weeks after injection 3, 3 months after injection 1 (right before biopsy 2), 2 weeks after biopsy 2
Secondary outcome [3] 405104 0
Area of scar (evaluated manually with measuring tape)
Timepoint [3] 405104 0
Right before biopsy 1, 2 weeks after biopsy 1 (right before injection 1), right before injection 2 (7-10 days after injection 1), right before injection 3 (7-10 days after injection 2), 7-10 days after injection 3, 3 weeks after injection 3, 3 months after injection 1 (right before biopsy 2), 2 weeks after biopsy 2

Eligibility
Key inclusion criteria
- The subject has a hypertrophic scar which has persisted for at least 3 months after the initial wound healed
- The hypertrophic scar is of an area of at least 1 x 1 cm2
- The hypertrophic scar is at least 5-15 mm in thickness, confirmed with ultrasonography
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- The scar is diagnosed as keloid
- The subject has systemic conditions such as diabetes mellitus, hypertension, etc
- The subject smoked or consumed alcohol within the last 6 months
- The hypertrophic scar received corticosteroid injection therapy within the last month
- Subjects have allergies to penicillin, streptomycin, and amphotericin

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 24510 0
Indonesia
State/province [1] 24510 0
Jakarta

Funding & Sponsors
Funding source category [1] 310578 0
University
Name [1] 310578 0
Program Pendanaan Perancangan dan Pengembangan Purwarupa (P5) by Universitas Indonesia
Country [1] 310578 0
Indonesia
Primary sponsor type
Individual
Name
Theddeus O. H. Prasetyono
Address
Department of Surgery, Plastic Surgery Division, Dr. Cipto Mangunkusumo National Central Public Hospital/Faculty of Medicine Universitas Indonesia, Diponegoro street No. 71, Senen, Central Jakarta, Jakarta 10320
Country
Indonesia
Secondary sponsor category [1] 311778 0
None
Name [1] 311778 0
Address [1] 311778 0
Country [1] 311778 0
Other collaborator category [1] 282133 0
Hospital
Name [1] 282133 0
Unit Pelayanan Terpadu Sel Punca Rumah Sakit Cipto Mangunkusumo-Fakultas Kedokteran Universitas Indonesia
Address [1] 282133 0
CMU 2 Building 5th floor, Cipto Mangunkusumo National Central Public Hospital, Kimia street No. 40, Pegangsaan, Menteng, Central Jakarta, Jakarta 10320
Country [1] 282133 0
Indonesia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310185 0
Health Research Ethics Committee Faculty of Medicine Universitas Indonesia/ Cipto Mangunkusumo Hospital
Ethics committee address [1] 310185 0
Ethics committee country [1] 310185 0
Indonesia
Date submitted for ethics approval [1] 310185 0
15/10/2019
Approval date [1] 310185 0
09/12/2019
Ethics approval number [1] 310185 0
19-10-1265

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116790 0
Prof Theddeus Octavianus Hari Prasetyono
Address 116790 0
Department of Surgery, Plastic Surgery Division, Dr. Cipto Mangunkusumo National Central Public Hospital/Faculty of Medicine Universitas Indonesia, Diponegoro street No. 71, Senen, Central Jakarta, Jakarta 10320
Country 116790 0
Indonesia
Phone 116790 0
+62817858899
Fax 116790 0
Email 116790 0
teddyohp@yahoo.com
Contact person for public queries
Name 116791 0
Theddeus Octavianus Hari Prasetyono
Address 116791 0
Department of Surgery, Plastic Surgery Division, Dr. Cipto Mangunkusumo National Central Public Hospital/Faculty of Medicine Universitas Indonesia, Diponegoro street No. 71, Senen, Central Jakarta, Jakarta 10320
Country 116791 0
Indonesia
Phone 116791 0
+62817858899
Fax 116791 0
Email 116791 0
teddyohp@yahoo.com
Contact person for scientific queries
Name 116792 0
Theddeus Octavianus Hari Prasetyono
Address 116792 0
Department of Surgery, Plastic Surgery Division, Dr. Cipto Mangunkusumo National Central Public Hospital/Faculty of Medicine Universitas Indonesia, Diponegoro street No. 71, Senen, Central Jakarta, Jakarta 10320
Country 116792 0
Indonesia
Phone 116792 0
+62817858899
Fax 116792 0
Email 116792 0
teddyohp@yahoo.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We did not take the consent from the subject to have their individual data accessible to public.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.