search
Back to results

Observation 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
Kaiyang Lv, MD-PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cryotherapy Effect

Eligibility Criteria

14 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

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

First Posted
November 16, 2021
Last Updated
September 22, 2022
Sponsor
Kaiyang Lv, MD-PhD
Collaborators
Zimmer Medical Devices (Shanghai) Co., Ltd.
search

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
Citations:
PubMed Identifier
29850643
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.
Results Reference
background
PubMed Identifier
19271380
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.
Results Reference
background
PubMed Identifier
22024331
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. No abstract available.
Results Reference
background
PubMed Identifier
22006130
Citation
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.
Results Reference
background
PubMed Identifier
19309424
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. No abstract available.
Results Reference
background
PubMed Identifier
20514799
Citation
Bowen RE. A novel approach to ablative fractional treatment of mature thermal burn scars. J Drugs Dermatol. 2010 Apr;9(4):389-92.
Results Reference
background
PubMed Identifier
22695102
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.
Results Reference
background
PubMed Identifier
10232811
Citation
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.
Results Reference
background
PubMed Identifier
8454790
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. doi: 10.1111/j.1524-4725.1993.tb03331.x.
Results Reference
background
PubMed Identifier
7054797
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. doi: 10.1097/00006534-198202000-00017.
Results Reference
background
PubMed Identifier
10376697
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. doi: 10.1001/archderm.135.6.691.
Results Reference
background
PubMed Identifier
24605197
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.
Results Reference
background
PubMed Identifier
25645051
Citation
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.
Results Reference
background
PubMed Identifier
24764516
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.
Results Reference
background
PubMed Identifier
25498262
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.
Results Reference
background
PubMed Identifier
15545541
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. doi: 10.1001/archderm.140.11.1333.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs