Observation of the Comfort and Efficacy of CO2 Laser Combined With Cryo 6 for Burn or Linear Scars.

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Cryotherapy Effect, Burn Scar, Scar; Previous Cesarean Section

Intervention / Treatment
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* Device: Cold-air cooling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 14-60 years; The patient agreed to participate in the experiment and signed the informed consent by himself/herself or his/her legal representative; The clinical diagnosis was burn scar or post-operative linear scar, and the total area was more than 5 cm2. No other treatment such as laser or chemical exfoliation was performed on the lesion within the recent half year. Skin lesions were free of bleeding, ulceration, infection and other conditions affecting the visual field of laser treatment. Exclusion Criteria: Patients with an active or established sun tan; Patients with history of allergic reaction to to topical anesthesia; Patients with history of keloid scarring, abnormal wound healing and/or prone to bruising; Skin malignant tumors or precancerous lesions; Patients with diabetes, heart disease, epilepsy, connective tissue disease, etc.; Pregnant or breastfeeding patients; Patients with recent skin infections (such as viral and bacterial infections); Patients who are using other methods to treat similar diseases; Patients who had taken isotretinoin within the past year; History of cryoglobulinaemia; History of cold agglutinin disease and cold haemolysis; History of cold urticaria; Parts of the body with impaired circulation; Raynaud's disease; Parts of the body with impaired sensitivity; Trophic disorders; Hypersensitivity to cold; Patients with mental illness; Other ineligible patients.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group: CO2 fractional laser alone<br>This group of patients is the treatment control group. During the treatment period, the cold-air cooling device Cryo 6 will be placed next to the laser equipment but not started. The air outlet position is about 3 to 7 centimeters away from the skin, and it will move slowly and synchronously according to the laser position. The skin temperature will be synchronously monitored and recorded by hand-held infrared thermometry. After the operation, the investigators use hospital's routine aftercare procedures, and continue to use hand-held infrared thermometry to synchronously monitor the skin temperature. | |
| Experimental: Combination group: CO2 fractional laser combined with Cryo 6<br>During the CO2 fractional laser treatment, cool the skin with cold-air cooling device Cryo 6. Set the wind to level 5, and the maximum time to 30 minutes. The air outlet position is about 3 to 7 centimeters away from the skin, and it will move slowly and synchronously according to the laser position. The skin temperature will be synchronously monitored by hand-held infrared thermometry and maintained at 0°C to 5°C. After the operation, the investigators use hospital's routine aftercare procedures and cooling with Cryo 6 on the skin synchronously. The wind level can be selected by patients themselves from level 3 to 7, and the time can be set for 5 minutes. Put the air outlet about 3 to 7 centimeters away from the skin, and move it slowly and dynamically in this area of skin to monitor and record the skin temperature synchronously. | Device: Cold-air cooling<br>* 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).<br>* Other names: Zimmer MedizinSysteme Cryo 6;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin temperature | The skin temperature will be monitored and recorded by hand-held infrared thermometry. | Baseline, immediately after treatment | 
| Number of treatment interruptions | The physician calculates the number of interruptions that the patient calls off during treatment. | Immediately after treatment |