scarring scars
Conditions
Interventions
The procedure consists of 3 microneedling sessions using an electric-powered
pen, performed on one abdominal scar half. The interval of the sessions is 4
weeks. Settings will be adjusted to particip
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Have an abdominal scar resulting from a DIEP flap breast reconstruction in the past 18 months, but at least 3 months ago; - Have a wish for improvement on pain, itching, color, stiffness, thickness, irregularity or overall scar quality with regard to the abdominal scar; - Age equal of above 18 years; - Dutch or English speaking, reading and writing; - Is able to provide informed consent IC; - Fitzpatrick type I-III
Exclusion criteria
Exclusion criteria: - Are currently applying or receiving any form of scar therapy what needs to be continued during the study; - Have permanent filler injections in the abdominal scar; - Have the desire to undergo scar reconstruction surgery during the study; - Are on chemotherapy or radiotherapy; - Have a presence of skin cancers, warts, solar keratosis, or any skin infection in the abdominal scar area; - Have keloid scarring in the abdominal scar area or the tendency to develop keloid scarring based on previous developed keloid scars; - Are not willing to use sun protecting factor (SPF) for the period of 4 weeks after each microneedling session; - Have an uncontrollable coagulation status; - Are or become palliative or terminal; - Have or develop a serious systemic disease; - Are pregnant or have the wish to become pregnant during the study; - Who are simultaneous participate in another scientific study interfering with the abdominal scar formation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient experienced scar quality for the treated scar half compared to the untreated scar half, using the Patient Scar Assessment Scale (PSAS) total score of the POSAS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters are: patient experienced scar quality, patient satisfaction, subjective assessment of scar quality, objective scar quality (color, thickness and elasticity measured with the Dermalab) and experienced side effects. | — |
Countries
Netherlands
Outcome results
None listed