To investigate the effect of microneedling on the patient overall opinion of the abdominal scar quality after a DIEP flap procedure comparing the treated part and the untreated part of the scar after 9 months of follow up.
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Microneedling shows promising results on improving scar characteristics and
overall scar opinion in acne and burn scarring. Because of this it is
interesting to study the effect of microneedling on surgical scarring. The
impact of donor site scarring after DIEP flap breast reconstruction and the
growing demand for minimally invasive scar treatments urge the need for a study
for this specific indication.
Study objective
To investigate the effect of microneedling on the patient overall opinion of
the abdominal scar quality after a DIEP flap procedure comparing the treated
part and the untreated part of the scar after 9 months of follow up.
Study design
A controlled split scar trial in Radboudumc.
Intervention
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 participants comfort and the clinical
visible endpoint of uniform pin-point bleeding.
Control: The other half of the scar remains untreated.
Study burden and risks
The microneedling device is applied with a CE marked device and will be used
within the intended use. The risk of the study design, intervention, study
population and social impact are negligible. The benefits of microneedling may
have a positive effect on the whole abdominal scar, since we offer to treat
also the untreated part of the scar after the study. We do not expect that the
microneedling procedure pose an extra risk or burden to patients.
Geert Grooteplein-Zuid 10
Nijmegen 6500 HB
NL
Geert Grooteplein-Zuid 10
Nijmegen 6500 HB
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL72993.091.20 |
| Other | NL8388 |