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Trial registered on ANZCTR


Registration number
ACTRN12622000558729
Ethics application status
Approved
Date submitted
29/12/2021
Date registered
12/04/2022
Date last updated
12/04/2022
Date data sharing statement initially provided
12/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigation on the use of hydrolysed ribonucleic acid (RNA) dissolving microneedle patch versus silicone sheets on appearance of post-surgical scars
Scientific title
The effect of a hydrolysed RNA dissolving microneedle patch compared to silicone sheets on the volume of scarring in post-surgical patients
Secondary ID [1] 306123 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertrophic scarring 324796 0
Post-surgical scarring 325456 0
Condition category
Condition code
Skin 322246 322246 0 0
Dermatological conditions
Surgery 322836 322836 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Hydrolysed RNA microneedle patch
The microneedles comprise of hyaluronic acid and are 300 nm in height. The patch needle density is 339 needles per cm2.
The duration of hydrolysed RNA microneedle patch application is for 60 days
The first patch will be applied at the point of recruitment. This will be approximately 2 weeks after surgery, when the patient is routinely reviewed for removal of stitches.
The study co-ordinator who has been trained to apply the patches will demonstrate the first application, and educate the patient on the appropriate method of application
Unused patches will be reviewed at the 1st and 2nd visit to assess adherence. Unused patches will be returned at the 2nd visit. The 1st visit will occur at the end of 30 days, and the 2nd visit will occur at the end of 60 days.


Application instructions
1. Open the packaging and remove the dressing.
2. An alcohol swab is included in the packaging. Swab the area of intended application.
3. Cut to appropriate length of the wound to be applied using a clean pair of scissors.
4. Apply the microneedles side onto the wound/scar and press the patch firmly for 30 sec.
5. The patch contains glue at the edges. Remove the release film to stick the patch to the surrounding normal skin.

Dressing change and removal:
1. The sheet is to be applied for 12 hours a day and is to be changed daily at the next daily shower.
2. If the patch falls off accidentally, the patch may be reapplied if it is not dirty. If dirtied, to leave the wound/scar open until the next application.
Intervention code [1] 322532 0
Treatment: Other
Comparator / control treatment
Comparator: Silicone Sheets
Application instructions
1. Open the packaging and remove the dressing.
2. Cut to appropriate length of the wound to be applied using a clean pair of scissors.
3. Remove the release film and apply Mepiform® over the wound/scar.

Dressing change and removal:
1. The sheet is to be applied for 12 hours a day and is to be changed daily at the next daily shower.
2. If the sheet falls off accidentally, the sheet may be reapplied if it is not dirty. If dirty, it may be washed and reapplied.

The first patch will be applied at the point of recruitment. This will be approximately 2 weeks after surgery, when the patient is routinely reviewed for removal of stitches.
The study co-ordinator who has been trained to apply the patches will demonstrate the first application, and educate the patient on the appropriate method of application
Unused patches will be reviewed at the 1st and 2nd visit to assess adherence. Unused patches will be returned at the 2nd visit. The 1st visit will occur at the end of 30 days, and the 2nd visit will occur at the end of 60 days.
Control group
Active

Outcomes
Primary outcome [1] 330014 0
Scar appearance assessed clinically by an investigator using the Vancouver Scar Scale (VSS)
Timepoint [1] 330014 0
Outcome will be assessed at baseline, 30 days post-intervention commencement, and 60 days post-intervention commencement (primary endpoint)
Primary outcome [2] 330015 0
Scar appearance assessed by 2 blinded investigators using clinical photographs and scored using the Scar Cosmesis Assessment and Rating (SCAR) scale. SCAR scale score will be scored for each half of the scar and compared.
Timepoint [2] 330015 0
Outcome will be assessed at baseline, 30 days post-intervention commencement, and 60 days post-intervention commencement (primary endpoint)
Secondary outcome [1] 404596 0
Differences in scar elevation measured by high resolution (0.1mm resolution) 3D imaging
Timepoint [1] 404596 0
Outcome will be assessed at baseline, 30 days post-intervention commencement, and 60 days post-intervention commencement
Secondary outcome [2] 404597 0
Composite secondary outcome: Differences in epidermal thickness and dermal components across a 3D volume will measured by high-definition optical coherence tomography
Timepoint [2] 404597 0
Outcome will be assessed at baseline, 30 days post-intervention commencement, and 60 days post-intervention commencement
Secondary outcome [3] 404599 0
Side effects will be reported using a study-specific questionnaire during each study visit documented in accordance with the Common Terminology Criteria for Adverse Events (CTCAE5.0)

Possible side effects of the hydrolysed RNA dissolving microneedle patch applied to post-surgical wounds will be monitored for and include:
- Infection
- Irritation
- Allergic reactions
- Erosions or ‘rawness’ on the wound surface
- Maceration of wound
Timepoint [3] 404599 0
Outcome will be assessed at baseline, 30 days post-intervention commencement, and 60 days post-intervention commencement
Secondary outcome [4] 406987 0
Differences in patient-reported levels of pain in each half of the scar using a 11-point numerical rating scale
Timepoint [4] 406987 0
Outcome will be assessed at baseline, 30 days post-intervention commencement, and 60 days post-intervention commencement
Secondary outcome [5] 407895 0
Differences in patient-reported levels of itch in each half of the scar using a 11-point numerical rating scale
Timepoint [5] 407895 0
Outcome will be assessed at baseline, 30 days post-intervention commencement, and 60 days post-intervention commencement

Eligibility
Key inclusion criteria
The inclusion criteria would be:
a. Adult
b. Age 21-75
c. 2 weeks (+/- 3 days) after surgical operation with incision requiring stitches
d. Post-stitch removal
e. Wound closure/union achieved
Minimum age
21 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria would include:
a. Pregnant or lactating participants
b. Participants with wound infection
c. Participants assessed to be uncooperative or unable to self-administer the interventions
d. Participants with known contact allergy to ingredients in the patch formulation (comprising hyaluronic acid, hydrolysed RNA and glue), isopropyl alcohol, and/or silicone

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This is a randomized intra-individually controlled trial, hence all participants receive both control and intervention treatment. Whether the proximal or distal half of the wound receive control vs intervention treatment is randomised.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Baseline characteristics of the study population will be summarized using descriptive statistics. The primary objective is to compare the effect on appearance of post-surgical scars between daily application of hydrolysed RNA-embedded dissolving microneedles and daily application of silicone sheets after 30 days and 60 days. Paired t-test (if data is normally distributed) or Wilcoxon signed-rank test will be used to compare the scar appearance measured by VSS score at baseline, at 30 days and at 60 days of treatment. Similar comparison will also be done based on the scar elevation score measured by 3D imaging, investigator assessment of degree of improvement and patient self-assessment of pain and itch score. Significance will be assessed at a level of 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/04/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
54
Accrual to date
Final
Recruitment outside Australia
Country [1] 24467 0
Singapore
State/province [1] 24467 0

Funding & Sponsors
Funding source category [1] 310471 0
Hospital
Name [1] 310471 0
National Skin Centre
Country [1] 310471 0
Singapore
Primary sponsor type
Individual
Name
A/Prof Tey Hong Liang
Address
National Skin Centre
1 Mandalay Road
Singapore 308205
Country
Singapore
Secondary sponsor category [1] 311622 0
None
Name [1] 311622 0
Address [1] 311622 0
Country [1] 311622 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310102 0
National Healthcare Group Domain Specific Review Board
Ethics committee address [1] 310102 0
Nexus@One-North (South Tower),
No. 3, Fusionopolis Link, #03-08, Singapore 138543
Ethics committee country [1] 310102 0
Singapore
Date submitted for ethics approval [1] 310102 0
Approval date [1] 310102 0
16/12/2021
Ethics approval number [1] 310102 0

Summary
Brief summary
A common complication of wounds is exuberant growth of fibrotic scar tissue, resulting in hypertrophic scars and keloids. Such scarring can be significantly disfiguring and places an undue physical and psychological burden on patients. There is still no clinically effective therapy that prevents pathological scar formation after wounding. Topical silicone applications or silicone sheets are regularly used in an attempt to improve the appearance of scars post-wounding; however, these interventions have not been shown to be clinically effective.

Scar formation is mediated by a number of molecular factors that stimulate and organize collagen formation. In recent years, the secreted protein acidic and rich in cysteine (SPARC) has been found to play a key role in mediating procollagen processing and integration into collagen fibers. Inhibition of SPARC protein expression has been shown in vitro to reduce fibrosis through formation of less total collagen and fewer thick collagen fibers and in mouse models to reduce chemical-induced dermal fibrosis. Localized inhibition of SPARC protein expression at the site of wound closure, therefore, has the potential to reduce fibrosis and improve scar appearance.

Hyaluronic acid dissolving microneedles embedded with hydrolysed RNA is a recently developed product classified as a cosmetic product by the Health Science Authority, Singapore. The hydrolysed RNA comprises siRNA directed against SPARC protein expression and thus has the potential to prevent formation of pathological scars in wounds.

The current study aims to compare the effect on appearance of post-surgical scars between daily application of hydrolysed RNA-embedded dissolving microneedles and daily application of silicone sheets.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116478 0
A/Prof Hong Liang Tey
Address 116478 0
National Skin Centre
1 Mandalay Rd, Singapore 308205
Country 116478 0
Singapore
Phone 116478 0
+6563506256
Fax 116478 0
Email 116478 0
[email protected]
Contact person for public queries
Name 116479 0
Hong Liang Tey
Address 116479 0
National Skin Centre
1 Mandalay Rd, Singapore 308205
Country 116479 0
Singapore
Phone 116479 0
+6563506256
Fax 116479 0
Email 116479 0
[email protected]
Contact person for scientific queries
Name 116480 0
Hong Liang Tey
Address 116480 0
National Skin Centre
1 Mandalay Rd, Singapore 308205
Country 116480 0
Singapore
Phone 116480 0
+6563506256
Fax 116480 0
Email 116480 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The minimal data set required to replicate all study findings reported in the article, as well as related methods will be shared.
When will data be available (start and end dates)?
Data will be available for 5 years from study commencement, tentatively planned for 1 Feb 2022 to 31 Jan 2026
Available to whom?
It will be available on case-by-case basis at the discretion of Principal Investigator
Available for what types of analyses?
It will be available for all scientific analyses, including but not limited to verification of study results, inclusion in meta-analyses
How or where can data be obtained?
Access is subject to approval by Principal Investigator (email to [email protected])


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.