An interventional study of Cold-air cooling in Cryotherapy Effect, Burn Scar and Scar; Previous Cesarean Section, sponsored by Kaiyang Lv, MD-PhD. Status unknown at 1 site in China. Open to participants aged 14 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-27.
Sponsored by Kaiyang Lv, MD-PhD · Not applicable, Interventional, and Supportive care
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.
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.
317 studies on the registry are indexed under Cicatrix; 54 are open to participants now.
This study's planned enrollment of 40 is close to the median of 40 across 260 interventional studies indexed under Cicatrix.
Browse Cicatrix studies →This is the only study on the registry with Kaiyang Lv, MD-PhD as lead sponsor.
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Exclusion Criteria:
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.
Device: Cold-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).
Also known as: Zimmer MedizinSysteme Cryo 6
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.
Time frame: Immediately after treatment
Skin temperature
The skin temperature will be monitored and recorded by hand-held infrared thermometry.
Time frame: Baseline, immediately after treatment
Number of treatment interruptions
The physician calculates the number of interruptions that the patient calls off during treatment.
Time frame: Immediately after treatment
Scar area
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
Scar color
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
Scar volume
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
Scar melamin
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
Scar erythema
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
Satisfaction evaluation
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.
Plan to share: No
Started Nov 2021 (actual). Primary completion is estimated for Jun 2023, 19 months after the start.
Of 74 non-industry interventional studies with no phase under Cicatrix, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 19 months is below that.
Counting every sponsor, half of 88 studies reached it within 20 months; a quarter within 10 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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