None listed
Conditions
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.
Interventions
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
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.
Sponsors
A/Prof Tey Hong Liang
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
21 Years to 75 Years
Healthy volunteers
No
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
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
Outcome results
None listed