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Microneedling after reconstructive scarring

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28278
Enrollment
30
Registered
2020-02-17
Start date
2020-09-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal scars after DIEP flap breast reconstruction

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 participan

Sponsors

Radboudumc and University of Applied Sciences Utrecht
Lead Sponsor

Eligibility

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 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).

Exclusion criteria

Exclusion criteria: - 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.

Design outcomes

Primary

MeasureTime frame
Patient experienced scar quality using the Patient Scar Assessment Scale (PSAS) total score of the POSAS.

Secondary

MeasureTime frame
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.

Contacts

Public ContactKristel Everaars

Plastic Surgery, Radboudumc

kristel.everaars@radboudumc.nl06-38763133

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)