surgical scar scar prevention, LED
Conditions
Interventions
The device is randomly split into 2 identical part. The treatment side is a LED light 830 nm (Power density of 5 mW/cm2 and Energy density of 4.5 J/cm2). Participants will be instructed to use the de
Experimental Device,Sham Comparator Device
LED light ,Sham control
Sponsors
Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
Eligibility
Sex/Gender
All
Age
20 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 20 to 70 years, male or female. 2. Underwent surgery within the past 1 month prior to enrollment. 3. Ethnically Thai of Asian descent. 4. Willing to voluntarily participate in the study and consent to photography of the surgical scar area.
Exclusion criteria
Exclusion criteria: 1. Presence of dermatitis or skin infection at the treatment area. 2. History of postoperative wound infection before the treatment. 3. Presence of serious underlying diseases or use of immunosuppressive medications, such as corticosteroids or chemotherapy. 4. Presence of hypertrophic scars or keloids at the treatment site. 5. Presence of a psychiatric disorder diagnosed by a psychiatrist. 6. Refusal to allow photography for treatment evaluation. 7. History of photosensitive skin conditions, such as rash or eruption induced by light exposure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physician assesment baseline, day30 (the day of last session), 1, 3 and 6 months after complete all treatments Vancouver scar scale,Physician assesment baseline, day30 (the day of last session), 1, 3 and 6 months after complete all treatments The Patient and Observer Scar Assessment Scale,Volume baseline, day30 (the day of last session), 1, 3 and 6 months after complete all treatments Antera3D,Pigmentation baseline, day30 (the day of last session), 1, 3 and 6 months after complete all treatments Antera3D,Redness baseline, day30 (the day of last session), 1, 3 and 6 months after complete all treatments Antera 3D | — |
Secondary
| Measure | Time frame |
|---|---|
| Scar area baseline, day30 (the day of last session), 1, 3 and 6 months after complete all treatments Quantificare,Participants assessment baseline, day30 (the day of last session), 1, 3 and 6 months after complete all treatments The Patient and Observer Scar Assessment Scale,Physician assessment day30 (the day of last session), 1, 3 and 6 months after complete all treatments Visual analog scale (0 is not improve, 10 is the best outcome),Participants assessment day30 (the day of last session), 1, 3 and 6 months after complete all treatments Visual analog scale (0 is not improve, 10 is the best outcome),Safety baseline, day30 (the day of last session), 1, 3 and 6 months after complete all treatments adverse event,Pain score Every treatment sessions Visual analog scale (0 is not painful at all and 10 is the worst imaginable pain) | — |
Countries
Thailand
Contacts
Public ContactWoraphong Manuskiatti
Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
Outcome results
None listed