Burn Scar, Cryotherapy Effect, Scar; Previous Cesarean Section
Conditions
Brief summary
To investigate the effect of 10,600 nm CO2 laser combined with Zimmer Cryo 6 forced cold air device on the comfort and efficacy of patients with burn scars or post-operative linear scars, and to provide a safer, more effective and more satisfactory program for clinical treatment of burn scars or post-operative linear scars.
Detailed description
Objective: To investigate the effect of 10,600 nm CO2 laser combined with the cold-air cooling device Zimmer Cryo 6 on the comfort and efficacy of patients with burn scars or post-operative linear scars, and to provide a safer, more effective and more satisfactory program for clinical treatment of burn scars or post-operative linear scars. Secondary objective: To investigate the adverse effects of the cold-air cooling device Zimmer Cryo 6 in combination with the 10,600 nm CO2 fractional laser treatment for patients with burn scars or post-operative linear scars.
Interventions
DEVICECold-air cooling
Cryo 6 works with a compressor system like those in refrigerators and uses ambient air to generate a permanent stream of cold air with a maximum flow to 1000 L/min and a temperature as low as -30°C, depending on the cooling delivery system and the desired cooling level (range 1-9).
Sponsors
Zimmer Medical Devices (Shanghai) Co., Ltd.
Kaiyang Lv, MD-PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 14-60 years; 2. The patient agreed to participate in the experiment and signed the informed consent by himself/herself or his/her legal representative; 3. The clinical diagnosis was burn scar or post-operative linear scar, and the total area was more than 5 cm2. 4. No other treatment such as laser or chemical exfoliation was performed on the lesion within the recent half year. 5. Skin lesions were free of bleeding, ulceration, infection and other conditions affecting the visual field of laser treatment.
Exclusion criteria
1. Patients with an active or established sun tan; 2. Patients with history of allergic reaction to to topical anesthesia; 3. Patients with history of keloid scarring, abnormal wound healing and/or prone to bruising; 4. Skin malignant tumors or precancerous lesions; 5. Patients with diabetes, heart disease, epilepsy, connective tissue disease, etc.; 6. Pregnant or breastfeeding patients; 7. Patients with recent skin infections (such as viral and bacterial infections); 8. Patients who are using other methods to treat similar diseases; 9. Patients who had taken isotretinoin within the past year; 10. History of cryoglobulinaemia; 11. History of cold agglutinin disease and cold haemolysis; 12. History of cold urticaria; 13. Parts of the body with impaired circulation; 14. Raynaud's disease; 15. Parts of the body with impaired sensitivity; 16. Trophic disorders; 17. Hypersensitivity to cold; 18. Patients with mental illness; 19. Other ineligible patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale (NRS) | Immediately after treatment | The Numeric Rating Scale (NRS) is a numbered version of the Visual Analog Pain Scale (VAS) in which the patient can select one number that best describes the pain. Scale from minimum 0 to maximum 10 for total 11 integers. 0 represents no pain, and 10 represents worst pain imaginable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin temperature | Baseline, immediately after treatment | The skin temperature will be monitored and recorded by hand-held infrared thermometry. |
| Number of treatment interruptions | Immediately after treatment | The physician calculates the number of interruptions that the patient calls off during treatment. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Scar melamin | Baseline, 1 month after the 1st treatment, 1 month after the 2nd treatment, 1 month after the 3rd treatment | Analyze the scar pattern using Antera 3D software for scar melanin. |
| Scar area | Baseline, 1 month after the 1st treatment, 1 month after the 2nd treatment, 1 month after the 3rd treatment | Analyze the scar pattern using Antera 3D software for Scar area (cm2). |
| Satisfaction evaluation | 1 month after the 1st and the 3rd treatments. | The patients were rated as very dissatisfied, dissatisfied, fair, satisfied, and very satisfied with the improvement of scars. |
| Scar erythema | Baseline, 1 month after the 1st treatment, 1 month after the 2nd treatment, 1 month after the 3rd treatment | Analyze the scar pattern using Antera 3D software for scar erythema. |
| Scar color | Baseline, 1 month after the 1st treatment, 1 month after the 2nd treatment, 1 month after the 3rd treatment | Analyze the scar pattern using Antera 3D software for scar color (CIE L\*a\*B\*). |
| Scar volume | Baseline, 1 month after the 1st treatment, 1 month after the 2nd treatment, 1 month after the 3rd treatment | Analyze the scar pattern using Antera 3D software for scar volume (cm3). |
Countries
China
Contacts
Primary ContactKai-Yang Lv, MD-PhD
Outcome results
None listed