Back to resultsObservation of the Comfort and Efficacy of CO2 Laser Combined With Cryo 6 for Burn or Linear Scars.
Primary Purpose
Cryotherapy Effect, Burn Scar, Scar; Previous Cesarean Section
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cold-air cooling
Sponsored by
About this trial
This is an interventional supportive care trial for Cryotherapy Effect
Eligibility Criteria
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.
Sites / Locations
- Xinhua Hospital affiliated to Shanghai Jiaotong University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group: CO2 fractional laser alone
Combination group: CO2 fractional laser combined with Cryo 6
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Skin temperature
The skin temperature will be monitored and recorded by hand-held infrared thermometry.
Number of treatment interruptions
The physician calculates the number of interruptions that the patient calls off during treatment.
Full Information
NCT ID
NCT05555602
First Posted
November 16, 2021
Last Updated
September 22, 2022
Sponsor
Kaiyang Lv, MD-PhD
Collaborators
Zimmer Medical Devices (Shanghai) Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05555602
Brief Title
Observation of the Comfort and Efficacy of CO2 Laser Combined With Cryo 6 for Burn or Linear Scars.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 23, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kaiyang Lv, MD-PhD
Collaborators
Zimmer Medical Devices (Shanghai) Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cryotherapy Effect, Burn Scar, Scar; Previous Cesarean Section
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group: CO2 fractional laser alone
Arm Type
No Intervention
Arm Description
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.
Arm Title
Combination group: CO2 fractional laser combined with Cryo 6
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cold-air cooling
Other Intervention Name(s)
Zimmer MedizinSysteme Cryo 6
Intervention Description
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).
Primary Outcome Measure Information:
Title
Numeric Rating Scale (NRS)
Description
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.
Time Frame
Immediately after treatment
Secondary Outcome Measure Information:
Title
Skin temperature
Description
The skin temperature will be monitored and recorded by hand-held infrared thermometry.
Time Frame
Baseline, immediately after treatment
Title
Number of treatment interruptions
Description
The physician calculates the number of interruptions that the patient calls off during treatment.
Time Frame
Immediately after treatment
Other Pre-specified Outcome Measures:
Title
Scar area
Description
Analyze the scar pattern using Antera 3D software for Scar area (cm2).
Time Frame
Baseline, 1 month after the 1st treatment, 1 month after the 2nd treatment, 1 month after the 3rd treatment
Title
Scar color
Description
Analyze the scar pattern using Antera 3D software for scar color (CIE L*a*B*).
Time Frame
Baseline, 1 month after the 1st treatment, 1 month after the 2nd treatment, 1 month after the 3rd treatment
Title
Scar volume
Description
Analyze the scar pattern using Antera 3D software for scar volume (cm3).
Time Frame
Baseline, 1 month after the 1st treatment, 1 month after the 2nd treatment, 1 month after the 3rd treatment
Title
Scar melamin
Description
Analyze the scar pattern using Antera 3D software for scar melanin.
Time Frame
Baseline, 1 month after the 1st treatment, 1 month after the 2nd treatment, 1 month after the 3rd treatment
Title
Scar erythema
Description
Analyze the scar pattern using Antera 3D software for scar erythema.
Time Frame
Baseline, 1 month after the 1st treatment, 1 month after the 2nd treatment, 1 month after the 3rd treatment
Title
Satisfaction evaluation
Description
The patients were rated as very dissatisfied, dissatisfied, fair, satisfied, and very satisfied with the improvement of scars.
Time Frame
1 month after the 1st and the 3rd treatments.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kai-Yang Lv, MD-PhD
Phone
+8613816983691
Email
lvkaiyang@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yo-Yu Tseng, M.Sc
Organizational Affiliation
Zimmer Medical Devices (Shanghai) Co., Ltd.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kai-Yang Lv, MD-PhD
Phone
+8613816983691
Email
lvkaiyang@hotmail.com
First Name & Middle Initial & Last Name & Degree
Yo-Yu Tseng, M.Sc
12. IPD Sharing Statement
Plan to Share IPD
No
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Observation of the Comfort and Efficacy of CO2 Laser Combined With Cryo 6 for Burn or Linear Scars.
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