The effect of microneedling on abdominal scarring after DIEP flap breast reconstructio

Completed

Conditions: scarring
scars
10040790

Registration Number: NL-OMON55074

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

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

- 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Patient experienced scar quality for the treated scar half compared to the<br /><br>untreated scar half, using the Patient Scar Assessment Scale (PSAS) total score<br /><br>of the POSAS. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters are: patient experienced scar quality, patient<br /><br>satisfaction, subjective assessment of scar quality, objective scar quality<br /><br>(color, thickness and elasticity measured with the Dermalab) and experienced<br /><br>side effects.</p><br>