Primary objective1. To test the safety of cold plasma treatment: SAE in * 10% of participants, no pain (VAT * 2) and no local skin reaction: redness, blister formation, pain or itching. Secondary objectives:The effect of cold plasma treatment on : 1…
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
- Skin and subcutaneous tissue disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety of plasma treatment: occurance of SAE and pain scores will be recorded.
Plasma treatment is considere safe when in * 10% moderate SAE due to the
treatment.
Pain: a VAT score above 2 is considered as a cutoff value for SAE.
Secondary outcome
The effect of plasma treatment on TEWL, local skin temperature, colorimetry and
bacterial load will be determined.
Background summary
Burn patients are at risk of wound colonization or infection because of reduced
immune responses and a large exposed surface area. The presence of
micro-organisms in (burn) wounds can have a serious impact on wound healing and
can result in complications and a longer length of stay. Antimicrobial
treatments with crèmes are not sufficient and can even be detrimental to wound
healing. Since bacterial (multi)drug resistance continues to increase steadily,
use of (systemic) antibiotics is limited.
Cold gas plasma can offer a new alternative to combat bacteria in (burn)wounds.
Cold gas plasma can be created by discharging gas at roomtemperature, at normal
atmospheric pressure. Contact of plasma with ambient air results in the
creation of active particles such as oxygen and nitrogen radicals. Production
of these particles can be adjusted to a safe level. Plasma has the ability to
kill high numbers of bacteria in minutes whitout causing damage to skin cells
and is therefor a powerful method to prevent and treat infections.
Study objective
Primary objective
1. To test the safety of cold plasma treatment: SAE in * 10% of participants,
no pain (VAT * 2) and no local skin reaction: redness, blister formation, pain
or itching.
Secondary objectives:
The effect of cold plasma treatment on :
1. skin characteristics: colour/pigmentation, temperature, barrière function
(TEWL)
2. killing of bacteria on intact skin
Study design
1. Tests for safety and absence of pain on 10 volunteers.
2. Determine the effect of plasma on bacterial survival on skin of 15
volunteers. Safety aspects are included as well.
Intervention
Volunteers will be treated once with cold gas plasma.
Study burden and risks
Expected risks include skin sensations (pain, paresthia, warmth), which in
previous studies ranged from none to mild symptoms that were deemed acceptable
by the subjects.
Zeestraat 29
Beverwijk 1940EA
NL
Zeestraat 29
Beverwijk 1940EA
NL
Listed location countries
Age
Inclusion criteria
-18 years or older,
-have completed informed consent forms;
-able and willing to comply with the research protocol;
-no language barrier
Exclusion criteria
- 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL52211.094.16 |