Cryotherapy Effect Clinical Trial
Official title:
Clinical Observation of the Comfort and Efficacy of Carbon Dioxide(CO2) Laser 10,600 nm Combined With Cold-air Cooling Device Zimmer Cryo 6 for Burn Scars or Linear Scars.
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 2023 |
Est. primary completion date | June 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 14 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Kaiyang Lv, MD-PhD | Zimmer Medical Devices (Shanghai) Co., Ltd. |
China,
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Scar area | Analyze the scar pattern using Antera 3D software for Scar area (cm2). | Baseline, 1 month after the 1st treatment, 1 month after the 2nd treatment, 1 month after the 3rd treatment | |
Other | Scar color | Analyze the scar pattern using Antera 3D software for scar color (CIE L*a*B*). | Baseline, 1 month after the 1st treatment, 1 month after the 2nd treatment, 1 month after the 3rd treatment | |
Other | Scar volume | Analyze the scar pattern using Antera 3D software for scar volume (cm3). | Baseline, 1 month after the 1st treatment, 1 month after the 2nd treatment, 1 month after the 3rd treatment | |
Other | Scar melamin | Analyze the scar pattern using Antera 3D software for scar melanin. | Baseline, 1 month after the 1st treatment, 1 month after the 2nd treatment, 1 month after the 3rd treatment | |
Other | Scar erythema | Analyze the scar pattern using Antera 3D software for scar erythema. | Baseline, 1 month after the 1st treatment, 1 month after the 2nd treatment, 1 month after the 3rd treatment | |
Other | Satisfaction evaluation | The patients were rated as very dissatisfied, dissatisfied, fair, satisfied, and very satisfied with the improvement of scars. | 1 month after the 1st and the 3rd treatments. | |
Primary | Numeric Rating Scale (NRS) | 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. | Immediately after treatment | |
Secondary | Skin temperature | The skin temperature will be monitored and recorded by hand-held infrared thermometry. | Baseline, immediately after treatment | |
Secondary | Number of treatment interruptions | The physician calculates the number of interruptions that the patient calls off during treatment. | Immediately after treatment |
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