Patients with mammoplasty scar s on both sided of breast mammoplasty scar, picosecond laser, fractional 1064 nm picosecond laser
Conditions
Interventions
Treatment: 0.8 J/cm2, repetitive rate 10 Hz, spot size 8 mm, pulse width 750 ps, 2-5 passes
Early intervention: 0.6 J/cm2, repetitive rate 10 Hz, spot size 8 mm, pulse width 750 ps, 2 passes
Endpoi
Experimental Device,No Intervention No treatment
Picosecond laser 1064 nm,Control
Sponsors
Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
Lasermed Co., Ltd.
Eligibility
Sex/Gender
Female
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Female aged 18-60 years 2. Had hypertrophic scars on both breasts after breast surgery and did not receive any hypertrophic scar treatments in the past 6 months prior to enrolment or did bilateral breast surgery within 1 month prior to enrollment. 3. Conducted breast surgery due to breast cancer, breast augmentation, or breast reduction
Exclusion criteria
Exclusion criteria: 1. Patients having infection or active wound in the test area 2. Patients with herpes infection or having a history of herpes infection 3. Immunocompromised patients 4. Patients with connective tissue disease 5. Receiving immunosuppressive drugs 6. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skin texture (Roughness) Baseline, 1 , 3, and 6 months after treatment Antera analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| Scar volume Baseline, 1 , 3, and 6 months after treatment Antera analysis,Skin pigmentation Baseline, 1 , 3, and 6 months after treatment Antera analysis,Physician improvement scale Baseline, 1 , 3, and 6 months after treatment 6 points scale,Patient and Observer Scar Assessment Scale Baseline, 1 , 3, and 6 months after treatment POSAS score,Safety Baseline, 1 , 3, and 6 months after treatment Adverse event | — |
Countries
Thailand
Contacts
Public ContactWoraphong Manuskiatti
Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed