Intact SkinPhase 1NCT03007264
Cold Plasma for Wound Treatment, Safety Study
A Phase 1 study testing Cold Atmospheric Plasma in people with Intact Skin and Contaminant Given to Patient, run by Association of Dutch Burn Centres at 1 site in Netherlands.
Trial summary
In this study the application of cold atmospheric plasma (CAP) will be tested on intact skin of volunteers. To test safety, several skin parameters will be monitored, the antimicrobial effect will be investigated as well. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intact Skin, Contaminant Given to Patient
- What is being tested?
- Cold Atmospheric Plasma
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 Jun 2018to 26 Jul 2018
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able and willing to comply with the research protocol
- No language barrier
Who cannot join
- Atopic dermatitis or other skin disease
- Implanted electrical medical devices such cardiac pacemakers
- Pregnant or lactating women
- Patients with infected wounds.
- Life-threatening cardiac conductivity abnormality
- Active malignancy
- Women of childbearing age not using contraceptive measures
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Association of Dutch Burn Centres
Beverwijk, North Holland, 1942 LE
About this study
Official title: Safety Assessment of Cold Gas Plasma on Intact Skin
In this study the application of cold atmospheric plasma (CAP) will be tested on intact skin of volunteers. To test safety, several skin parameters will be monitored, the antimicrobial effect will be investigated as well. The investigators expect this treatment to have a good antimicrobial effect with acceptable, transient skin sensations.
Read the detailed description
Control of infection and bacterial colonisation constitutes a continuing challenge in patients with burns. Prevention of microbial contamination and infection is vital for burn wound care as bacterial presence can result in excessive inflammatory reactions, delayed re-epithelialisation, impaired matrix remodelling and bacteraemia. A novel method to decrease the likelihood of infection and to help cure wounds is cold atmospheric plasma (CAP). CAP has been shown in vitro to kill a wide range of pathogenic bacteria.
This safety study aims to demonstrate the safety, efficacy and efficiency of CAP for burn wound treatment. Intact skin of volunteers will be CAP treated. Local skin reaction (blister formation, pain, itching), erythema, local skin temperature, trans epidermal water loss (TEWL) and reduction of the bacterial load wil be monitored.
- Conditions
- Intact Skin, Contaminant Given to Patient
- Being tested
- Cold Atmospheric Plasma
- Keywords
- cold atmospheric plasma, pain, bacteria, skin parameters
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold Atmospheric PlasmaDevice
CAP will be applied on one volar arm of volunteers for a total of 2 minutes.
| Study group | Role | What they receive |
|---|---|---|
| CAP treated | Experimental | volar arm will be treated with cold atmospheric plasma. Receives: Device: Cold Atmospheric Plasma |
| CAP on bacteria | Experimental | volar arm with bacteria will be treated with cold atmospheric plasma. Receives: Device: Cold Atmospheric Plasma |
| no CAP on bacteria | No intervention | volar arm with bacteria will not be treated with cold atmospheric plasma. Sham comparator for measurements of skin parameters TEWL, temperature and bacterial load. |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
by using a visual analogue thermometer (VAT)
Measured: before to 30 minutes after treatment
Secondary outcomes (5)
local skin reaction
blister formation, itching
Measured: directly to 30 minutes after treatment
local skin temperature
thermographic analysis
Measured: before to 30 minutes after treatment
colour/pigmentation
erythema, redness of the skin, by using a Dermaspectrometer
Measured: before to 30 minutes after treatment
trans epidermal water loss
barrier function of the skin by using TEWAmeter
Measured: before to 30 minutes after treatment
reduction of the bacterial load
quantified with scrub wash method
Measured: directly to 5 minutes after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study start18 Jun 2018
- Primary completion12 Jul 2018
- Study completion26 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intact SkinStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association of Dutch Burn Centres
- Sponsor type
- University, hospital or other
- Collaborators
- Eindhoven University of Technology
- Responsible party
- Sponsor
- Investigators
- Esther Middelkoop, PhD, Principal investigator, Red Cross Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03007264
- Sponsor's protocol ID
- NBS 14.200-CAP1
- Other IDs
- NL52211.094.16
- Status last verified
- Jun 2018
- First submitted
- 23 Dec 2016
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kisch T, Schleusser S, Helmke A, Mauss KL, Wenzel ET, Hasemann B, Mailaender P, Kraemer R. The repetitive use of non-thermal dielectric barrier discharge plasma boosts cutaneous microcirculatory effects. Microvasc Res. 2016 Jul;106:8-13. doi: 10.1016/j.mvr.2016.02.008. Epub 2016 Mar 2.
PubMed 26944583Brehmer F, Haenssle HA, Daeschlein G, Ahmed R, Pfeiffer S, Gorlitz A, Simon D, Schon MP, Wandke D, Emmert S. Alleviation of chronic venous leg ulcers with a hand-held dielectric barrier discharge plasma generator (PlasmaDerm((R)) VU-2010): results of a monocentric, two-armed, open, prospective, randomized and controlled trial (NCT01415622). J Eur Acad Dermatol Venereol. 2015 Jan;29(1):148-55. doi: 10.1111/jdv.12490. Epub 2014 Mar 25.
PubMed 24666170
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Assessment of Cold Gas Plasma on Intact Skin
- ClinicalTrials.gov ID
- NCT03007264
- Acronym / sponsor ID
- NBS 14.200-CAP1
- Conditions
- Intact Skin, Contaminant Given to Patient
- Keywords
- cold atmospheric plasma, pain, bacteria, skin parameters
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Association of Dutch Burn CentresUniversity, hospital or other
- Collaborators
- Eindhoven University of Technology
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 12 Jul 2018 (actual)
- Study completion
- 26 Jul 2018 (actual)
- First posted
- 2 Jan 2017 (estimated)
- 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.
In this study the application of cold atmospheric plasma (CAP) will be tested on intact skin of volunteers. To test safety, several skin parameters will be monitored, the antimicrobial effect will be investigated as well. The investigators expect this treatment to have a good antimicrobial effect with acceptable, transient skin sensations.
Detailed description
Control of infection and bacterial colonisation constitutes a continuing challenge in patients with burns. Prevention of microbial contamination and infection is vital for burn wound care as bacterial presence can result in excessive inflammatory reactions, delayed re-epithelialisation, impaired matrix remodelling and bacteraemia. A novel method to decrease the likelihood of infection and to help cure wounds is cold atmospheric plasma (CAP). CAP has been shown in vitro to kill a wide range of pathogenic bacteria.
This safety study aims to demonstrate the safety, efficacy and efficiency of CAP for burn wound treatment. Intact skin of volunteers will be CAP treated. Local skin reaction (blister formation, pain, itching), erythema, local skin temperature, trans epidermal water loss (TEWL) and reduction of the bacterial load wil be monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CAP treated | Experimental | Device: Cold Atmospheric Plasmavolar arm will be treated with cold atmospheric plasma. |
| CAP on bacteria | Experimental | Device: Cold Atmospheric Plasmavolar arm with bacteria will be treated with cold atmospheric plasma. |
| no CAP on bacteria | No intervention | –volar arm with bacteria will not be treated with cold atmospheric plasma. Sham comparator for measurements of skin parameters TEWL, temperature and bacterial load. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Able and willing to comply with the research protocol
- No language barrier
Key exclusion criteria (7 listed)
- Atopic dermatitis or other skin disease
- Implanted electrical medical devices such cardiac pacemakers
- Pregnant or lactating women
- Patients with infected wounds.
- Life-threatening cardiac conductivity abnormality
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 Atmospheric PlasmaCAP will be applied on one volar arm of volunteers for a total of 2 minutes. | Device | CAP on bacteria, CAP treated |
Primary outcome
pain
Time frame: before to 30 minutes after treatment
by using a visual analogue thermometer (VAT)
5 secondary outcomes
local skin reaction
Time frame: directly to 30 minutes after treatment
local skin temperature
Time frame: before to 30 minutes after treatment
colour/pigmentation
Time frame: before to 30 minutes after treatment
trans epidermal water loss
Time frame: before to 30 minutes after treatment
reduction of the bacterial load
Time frame: directly to 5 minutes after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
- Results publication: PubMed 26944583Kisch T, Schleusser S, Helmke A, Mauss KL, Wenzel ET, Hasemann B, Mailaender P, Kraemer R. The repetitive use of non-thermal dielectric barrier discharge plasma boosts cutaneous microcirculatory effects. Microvasc Res. 2016 Jul;106:8-13. doi: 10.1016/j.mvr.2016.02.008. Epub 2016 Mar 2.
- Results publication: PubMed 24666170Brehmer F, Haenssle HA, Daeschlein G, Ahmed R, Pfeiffer S, Gorlitz A, Simon D, Schon MP, Wandke D, Emmert S. Alleviation of chronic venous leg ulcers with a hand-held dielectric barrier discharge plasma generator (PlasmaDerm((R)) VU-2010): results of a monocentric, two-armed, open, prospective, randomized and controlled trial (NCT01415622). J Eur Acad Dermatol Venereol. 2015 Jan;29(1):148-55. doi: 10.1111/jdv.12490. Epub 2014 Mar 25.
- 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.
Esther Middelkoop, PhD principal investigator
Red Cross Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cold Atmospheric Plasma in people with Intact Skin and Contaminant Given to Patient, run by Association of Dutch Burn Centres at 1 site in Netherlands.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 20 Aug 2018. 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 Netherlands. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain (time frame: before to 30 minutes 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 NCT03007264, which also lists 2 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 20 Aug 2018.