Microneedling after reconstructive scarring
- Conditions
- Abdominal scars after DIEP flap breast reconstruction
- Registration Number
- NL-OMON28278
- Lead Sponsor
- Radboudumc and University of Applied Sciences Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
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 of (at least 10 cm) the abdominal scar;
- Age equal or above 18 years;
- Dutch speaking, reading and writing;
- Able to provide informed consent;
- Fitzpatrick type I-III according to the classification of skin phototype (I-IV).
- Are currently applying or receiving any form of scar therapy what needs to be continued during the study;
- Consider 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 or become pregnant or have a wish to become pregnant during the study;
- Who are simultaneous participate in another scientific study interfering with the abdominal scar formation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient experienced scar quality using the Patient Scar Assessment Scale (PSAS) total score of the POSAS.
- Secondary Outcome Measures
Name Time Method Secondary parameters are: patient experienced scar quality, patient satisfaction, subjective assessment of scar quality, objective scar quality measured with the Dermalab and experienced side effects.