Cryotherapy EffectNCT05555602
Observation of the Comfort and Efficacy of CO2 Laser Combined With Cryo 6 for Burn or Linear Scars.
A study testing Cold-air cooling in people with Cryotherapy Effect and Burn Scar, run by Kaiyang Lv, MD-PhD at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 14 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cryotherapy Effect, Burn Scar, Scar; Previous Cesarean Section
- What is being tested?
- Cold-air cooling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 23 Nov 2021to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200092
Kai-Yang Lv, MD-PhD, +8613816983691, lvkaiyang@hotmail.com
Yo-Yu Tseng, M.Sc
About this study
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.
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.
Read the 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.
- Being tested
- Cold-air cooling
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold-air coolingDevice
Also called Zimmer MedizinSysteme Cryo 6
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Cold-air cooling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after treatment
Secondary outcomes (2)
Skin temperature
The skin temperature will be monitored and recorded by hand-held infrared thermometry.
Measured: Baseline, immediately after treatment
Number of treatment interruptions
The physician calculates the number of interruptions that the patient calls off during treatment.
Measured: Immediately after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start23 Nov 2021
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Cryotherapy EffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiyang Lv, MD-PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Medical Devices (Shanghai) Co., Ltd.
- Responsible party
- Sponsor-investigator, Kaiyang Lv, MD-PhD, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Yo-Yu Tseng, M.Sc, Principal investigator, Zimmer Medical Devices (Shanghai) Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555602
- Sponsor's protocol ID
- XH-21-010
- Status last verified
- Sep 2022
- First submitted
- 16 Nov 2021
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 29850643Waibel J, Beer K. Ablative fractional laser resurfacing for the treatment of a third-degree burn. J Drugs Dermatol. 2009 Mar;8(3):294-7.
PubMed 19271380Kwan 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.
PubMed 22024331Kineston 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.
PubMed 22006130Haedersdal 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.
PubMed 19309424Bowen RE. A novel approach to ablative fractional treatment of mature thermal burn scars. J Drugs Dermatol. 2010 Apr;9(4):389-92.
PubMed 20514799Tierney 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.
PubMed 22695102Altshuler 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.
PubMed 10232811Chess 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.
PubMed 8454790Gilchrest 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.
PubMed 7054797Kelly 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.
PubMed 10376697Kim 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.
PubMed 24605197Matias 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.
PubMed 25645051Handford 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.
PubMed 24764516McIntosh 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.
PubMed 25498262
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05555602
- Acronym / sponsor ID
- XH-21-010
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kaiyang Lv, MD-PhDUniversity, hospital or other
- Collaborators
- Zimmer Medical Devices (Shanghai) Co., Ltd.
- Study start
- 23 Nov 2021 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 27 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Cold-air coolingDuring 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. |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold-air coolingAlso: Zimmer MedizinSysteme Cryo 6Cryo 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). | Device | Combination group: CO2 fractional laser combined with Cryo 6 |
Primary outcome
Numeric Rating Scale (NRS)
Time frame: Immediately after treatment
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.
2 secondary outcomes
Skin temperature
Time frame: Baseline, immediately after treatment
Number of treatment interruptions
Time frame: Immediately after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Background: PubMed 29850643Tian 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.
- Background: PubMed 19271380Waibel J, Beer K. Ablative fractional laser resurfacing for the treatment of a third-degree burn. J Drugs Dermatol. 2009 Mar;8(3):294-7.
- Background: PubMed 22024331Kwan 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.
- Background: PubMed 22006130Kineston 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.
- Background: PubMed 19309424Haedersdal 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.
- Background: PubMed 20514799Bowen RE. A novel approach to ablative fractional treatment of mature thermal burn scars. J Drugs Dermatol. 2010 Apr;9(4):389-92.
- Background: PubMed 22695102Tierney 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.
- Background: PubMed 10232811Altshuler 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.
- Background: PubMed 8454790Chess 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.
- Background: PubMed 7054797Gilchrest 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.
- Background: PubMed 10376697Kelly 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.
- Background: PubMed 24605197Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yo-Yu Tseng, M.Sc principal investigator
Zimmer Medical Devices (Shanghai) Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold-air cooling in people with Cryotherapy Effect and Burn Scar, run by Kaiyang Lv, MD-PhD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kai-Yang Lv, MD-PhD (+8613816983691, lvkaiyang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (NRS) (time frame: Immediately after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05555602, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2022.