Skip to content

Treatment of surgical scars in breast reduction with laser device, to prevent scar hypertrophy.

Treatment of surgical scars in breast reduction with laser device, to prevent scar hypertrophy. - Laser treatment to prevent scar hypertrophy.

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON36674
Enrollment
30
Registered
2011-07-28
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

excessive scarring hypertrophic scarring

Interventions

The laser treatment that will be assessed in this study will be used at the end of the surgical operation only, directly after closure of the surgical wound. Breast reduction surgery is performed ex
Monocryl® 3.0 subcutaneously and Monocryl® 4.0 intra-cutaneously. After closure a part of the surgical wounds at the underside of both breasts (left and right) will be treated with the EkkyLiteTM la

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients undergoing breast reduction surgery with a wise pattern technique. - Older than 18 years of age. - Willing to participate.

Exclusion criteria

Exclusion criteria: - Dark skin (skin types V or VI, Fitzpatrick Skin Typing Test) - Pregnant woman - Malignant tumor skin disease - Bacterial or viral infectious skin disease - Immunosuppression (linked to a pathology or specific treatment) - BMI > 27 - Hart and/or lung disease

Design outcomes

Primary

MeasureTime frame
Outcomes of the Vancouver Scar Scale (VSS) and POSAS score at 12 months after surgery.

Secondary

MeasureTime frame
Objective scar measures: volume (3D), width, height, colour. Cosmetic appearance. The patient will rate the scar*s overall cosmetic aspect on a visual analogue scale. Two independent plastics surgeons will rate the overall aspect as well on basis of the photographs. Complications. Time course of scar formation using all parameter measures at earlier time points (10 days, 6 weeks, 3 and 6 months after surgery).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)