adjunctive treatment of laser and photon postoperative wound repair
Conditions
Interventions
Sponsors
Chinese People's Liberation Army Air Force Specialty Medical Center
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 18~65 years old (including the border value), gender is not limited; 2. Fitzpatrick skin staging of type III or IV; 3. The proposed facial laser surgery or photon surgery, and the skin barrier of the surgical area is damaged (the postoperative trauma does not exceed the dermis layer, and the scanning area of a single spot is not less than 20mm×20mm); 4. Sign the informed consent form and cooperate with the treatment and follow-up program.
Exclusion criteria
Exclusion criteria: 1. A known history of allergy to the ingredients (collagen) of the product being tested; 2. allergy or previous severe allergic reaction (e.g. anaphylaxis); 3. Light-sensitive persons, or persons who have taken light-sensitive medication within the last month; 4. People suffering from skin diseases (e.g. vitiligo, psoriasis, atopic dermatitis, etc.) that may affect the test results; 5. Having cancerous skin lesions or skin ulceration or inflammation; 6. history of diabetes or vascular disease; 7. history of facial scarring or poor wound healing; 8. skin that has been exposed to the sun within the last month; 9. Currently receiving radiotherapy or hormonal or immunosuppressive therapy; 10. Severe cardiac, hepatic, or renal dysfunction [ALT, AST > 3 times the upper limit of normal; creatinine > 1.5 times the upper limit of normal], which, as assessed by the investigator, affects the evaluation of efficacy and safety; 11. Alcoholics, severe mental disorders, or inability to comply with medical advice to cooperate with the treatment; 12. Women who are planning to have a baby within the last month, or who are pregnant or breastfeeding; 13. Participation in any other drug or medical device clinical trial within 3 months prior to screening; 14. The subject has significant facial skin pigmentation that, in the judgment of the investigator, interferes with the evaluation of the efficacy of the treatment; 15. Any other conditions that the investigator deems unsuitable for the subject to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective rate at 4 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in major sign scores after application of the patch on the day of surgery, and at 1 and 2 weeks postoperatively, compared with the immediate postoperative period (no patch applied);Difference in self-perceived symptom scores after application of the dressing on the day of surgery, and at 1 and 2 weeks postoperatively, compared with the immediate postoperative period (no dressing applied);Duration of erythema in the treated area;Difference between VAS scores at 1 and 2 weeks postoperatively in the immediate postoperative period value;Difference between red area and brown spot scores at 4 weeks postoperatively and immediate postoperative scores;Excellent rate of hyperpigmentation at 2 and 4 weeks after surgery;Patient comfort ratings; | — |
Countries
China
Contacts
Public ContactCai Hong
Chinese People's Liberation Army Air Force Specialty Medical Center
Outcome results
None listed