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

Cryotherapy Effect Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05555602
• Other study ID #: XH-21-010
• Status: Recruiting
• Phase: N/A
• Start date: November 23, 2021
• Est. completion date: December 2023

Study information

• Verified date: September 2022
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Kai-Yang Lv, MD-PhD
• Phone: +8613816983691
• Email: lvkaiyang[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Age 14-60 years;

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:

1. Patients with an active or established sun tan;

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.

Related Conditions & MeSH terms

• Burn Scar
• Burns
• Cicatrix
• Cryotherapy Effect
• Scar; Previous Cesarean Section

Intervention

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).

Locations

Country	Name	City	State
China	Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Kaiyang Lv, MD-PhD	Zimmer Medical Devices (Shanghai) Co., Ltd.

Country where clinical trial is conducted

China, 

References & Publications (16)

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. — View Citation

Bowen RE. A novel approach to ablative fractional treatment of mature thermal burn scars. J Drugs Dermatol. 2010 Apr;9(4):389-92. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Kineston D, Kwan JM, Uebelhoer NS, Shumaker PR. Use of a fractional ablative 10.6-µm 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. — View Citation

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. — View Citation

Matias AR, Ferreira M, Costa P, Neto P. Skin colour, skin redness and melanin biometric measurements: comparison study between Antera(®) 3D, Mexameter(®) and Colorimeter(®). Skin Res Technol. 2015 Aug;21(3):346-62. doi: 10.1111/srt.12199. Epub 2015 Feb 3. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Scar area	Analyze the scar pattern using Antera 3D software for Scar area (cm2).	Baseline, 1 month after the 1st treatment, 1 month after the 2nd treatment, 1 month after the 3rd treatment
Other	Scar color	Analyze the scar pattern using Antera 3D software for scar color (CIE L*a*B*).	Baseline, 1 month after the 1st treatment, 1 month after the 2nd treatment, 1 month after the 3rd treatment
Other	Scar volume	Analyze the scar pattern using Antera 3D software for scar volume (cm3).	Baseline, 1 month after the 1st treatment, 1 month after the 2nd treatment, 1 month after the 3rd treatment
Other	Scar melamin	Analyze the scar pattern using Antera 3D software for scar melanin.	Baseline, 1 month after the 1st treatment, 1 month after the 2nd treatment, 1 month after the 3rd treatment
Other	Scar erythema	Analyze the scar pattern using Antera 3D software for scar erythema.	Baseline, 1 month after the 1st treatment, 1 month after the 2nd treatment, 1 month after the 3rd treatment
Other	Satisfaction evaluation	The patients were rated as very dissatisfied, dissatisfied, fair, satisfied, and very satisfied with the improvement of scars.	1 month after the 1st and the 3rd treatments.
Primary	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	Skin temperature	The skin temperature will be monitored and recorded by hand-held infrared thermometry.	Baseline, immediately after treatment
Secondary	Number of treatment interruptions	The physician calculates the number of interruptions that the patient calls off during treatment.	Immediately after treatment