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

NCT05555602 | Unknown FDA Device

• 1 other identifier: XH-21-010
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cryotherapy Effect; Burn Scar; Scar; Previous Cesarean Section

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Skin temperature

  Baseline, immediately after treatment

• Number of treatment interruptions

  Immediately after treatment

Other Outcomes (6)

• Scar area

  Baseline, 1 month after the 1st treatment, 1 month after the 2nd treatment, 1 month after the 3rd treatment

• Scar color

  Baseline, 1 month after the 1st treatment, 1 month after the 2nd treatment, 1 month after the 3rd treatment

• Scar volume

  Baseline, 1 month after the 1st treatment, 1 month after the 2nd treatment, 1 month after the 3rd treatment

Study Arms (2)

Control group: CO2 fractional laser alone

NO INTERVENTION

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

EXPERIMENTAL

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

Interventions

Cold-air cooling DEVICE

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

Combination group: CO2 fractional laser combined with Cryo 6

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Kaiyang Lv, MD-PhD: lead
• Zimmer Medical Devices (Shanghai) Co., Ltd.: collaborator

Study Sites (1)

Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

Related Publications (16)

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• 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.

  PMID: 22006130 BACKGROUND

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  PMID: 19309424 BACKGROUND

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

  PMID: 20514799 BACKGROUND

• 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.

  PMID: 22695102 BACKGROUND

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• 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.

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• 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.

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  PMID: 24764516 BACKGROUND

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  PMID: 25498262 BACKGROUND

• 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.

  PMID: 15545541 RESULT

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yo-Yu Tseng, M.Sc

  Zimmer Medical Devices (Shanghai) Co., Ltd.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kai-Yang Lv, MD-PhD

CONTACT

+8613816983691; lvkaiyang@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Chief Physician, Associate Professor

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: September 27, 2022
• Study Start: November 23, 2021
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 27, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)