Observation of the Comfort and Efficacy of CO2 Laser Combined With Cryo 6 for Burn or Linear Scars.
NCT ID: NCT05555602
Last Updated: 2022-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2021-11-23
2023-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
No interventions assigned to this group
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.
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).
Interventions
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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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
14 Years
60 Years
ALL
Yes
Sponsors
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Zimmer Medical Devices (Shanghai) Co., Ltd.
UNKNOWN
Kaiyang Lv, MD-PhD
OTHER
Responsible Party
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Kaiyang Lv, MD-PhD
Associate Chief Physician, Associate Professor
Principal Investigators
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Yo-Yu Tseng, M.Sc
Role: PRINCIPAL_INVESTIGATOR
Zimmer Medical Devices (Shanghai) Co., Ltd.
Locations
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Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Tian H, Wang L, Xie W, Shen C, Guo G, Liu J, Han C, Ren L, Liang Y, Tang Y, Wang Y, Yin M, Zhang J, Huang Y. Epidemiologic and clinical characteristics of severe burn patients: results of a retrospective multicenter study in China, 2011-2015. Burns Trauma. 2018 May 23;6:14. doi: 10.1186/s41038-018-0118-z. eCollection 2018.
Waibel J, Beer K. Ablative fractional laser resurfacing for the treatment of a third-degree burn. J Drugs Dermatol. 2009 Mar;8(3):294-7.
Kwan JM, Wyatt M, Uebelhoer NS, Pyo J, Shumaker PR. Functional improvement after ablative fractional laser treatment of a scar contracture. PM R. 2011 Oct;3(10):986-7. doi: 10.1016/j.pmrj.2011.07.007. No abstract available.
Kineston D, Kwan JM, Uebelhoer NS, Shumaker PR. Use of a fractional ablative 10.6-mum carbon dioxide laser in the treatment of a morphea-related contracture. Arch Dermatol. 2011 Oct;147(10):1148-50. doi: 10.1001/archdermatol.2011.247. No abstract available.
Haedersdal M. Fractional ablative CO(2) laser resurfacing improves a thermal burn scar. J Eur Acad Dermatol Venereol. 2009 Nov;23(11):1340-1. doi: 10.1111/j.1468-3083.2009.03215.x. Epub 2009 Mar 4. No abstract available.
Bowen RE. A novel approach to ablative fractional treatment of mature thermal burn scars. J Drugs Dermatol. 2010 Apr;9(4):389-92.
Tierney EP, Hanke CW. The effect of cold-air anesthesia during fractionated carbon-dioxide laser treatment: Prospective study and review of the literature. J Am Acad Dermatol. 2012 Sep;67(3):436-45. doi: 10.1016/j.jaad.2011.01.026. Epub 2012 Jun 12.
Altshuler GB, Zenzie HH, Erofeev AV, Smirnov MZ, Anderson RR, Dierickx C. Contact cooling of the skin. Phys Med Biol. 1999 Apr;44(4):1003-23. doi: 10.1088/0031-9155/44/4/014.
Chess C, Chess Q. Cool laser optics treatment of large telangiectasia of the lower extremities. J Dermatol Surg Oncol. 1993 Jan;19(1):74-80. doi: 10.1111/j.1524-4725.1993.tb03331.x.
Gilchrest BA, Rosen S, Noe JM. Chilling port wine stains improves the response to argon laser therapy. Plast Reconstr Surg. 1982 Feb;69(2):278-83. doi: 10.1097/00006534-198202000-00017.
Kelly KM, Nelson JS, Lask GP, Geronemus RG, Bernstein LJ. Cryogen spray cooling in combination with nonablative laser treatment of facial rhytides. Arch Dermatol. 1999 Jun;135(6):691-4. doi: 10.1001/archderm.135.6.691.
Kim J, Shin W. How to do random allocation (randomization). Clin Orthop Surg. 2014 Mar;6(1):103-9. doi: 10.4055/cios.2014.6.1.103. Epub 2014 Feb 14.
Matias AR, Ferreira M, Costa P, Neto P. Skin colour, skin redness and melanin biometric measurements: comparison study between Antera((R)) 3D, Mexameter((R)) and Colorimeter((R)). Skin Res Technol. 2015 Aug;21(3):346-62. doi: 10.1111/srt.12199. Epub 2015 Feb 3.
Handford C, Buxton P, Russell K, Imray CE, McIntosh SE, Freer L, Cochran A, Imray CH. Frostbite: a practical approach to hospital management. Extrem Physiol Med. 2014 Apr 22;3:7. doi: 10.1186/2046-7648-3-7. eCollection 2014.
McIntosh SE, Opacic M, Freer L, Grissom CK, Auerbach PS, Rodway GW, Cochran A, Giesbrecht GG, McDevitt M, Imray CH, Johnson EL, Dow J, Hackett PH; Wilderness Medical Society. Wilderness Medical Society practice guidelines for the prevention and treatment of frostbite: 2014 update. Wilderness Environ Med. 2014 Dec;25(4 Suppl):S43-54. doi: 10.1016/j.wem.2014.09.001.
Raulin C, Grema H. Single-pass carbon dioxide laser skin resurfacing combined with cold-air cooling: efficacy and patient satisfaction of a prospective side-by-side study. Arch Dermatol. 2004 Nov;140(11):1333-6. doi: 10.1001/archderm.140.11.1333.
Other Identifiers
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XH-21-010
Identifier Type: -
Identifier Source: org_study_id
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