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.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Numeric Rating Scale (NRS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 cm
- •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.
排除标准
- •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.
研究组 & 干预措施
Control group: CO2 fractional laser alone
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.
Combination group: CO2 fractional laser combined with Cryo 6
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.
干预措施: Cold-air cooling (Device)
结局指标
主要结局
Numeric Rating Scale (NRS)
时间窗: 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.
次要结局
- Skin temperature(Baseline, immediately after treatment)
- Number of treatment interruptions(Immediately after treatment)
研究者
Kaiyang Lv, MD-PhD
Associate Chief Physician, Associate Professor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine