Clinical trial NCT03007264: Cold Plasma for Wound Treatment, Safety Study
Official title: Safety Assessment of Cold Gas Plasma on Intact Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Intact Skin
Contaminant Given to Patient
Keywords: cold atmospheric plasma
pain
bacteria
skin parameters
Lead sponsor: Association of Dutch Burn Centres
Sponsor class: OTHER
Collaborators: name: Eindhoven University of Technology
First posted: 2017-01-02
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: pain
timeFrame: before to 30 minutes after treatment
Secondary outcomes:
measure: local skin reaction
timeFrame: directly to 30 minutes after treatment
measure: local skin temperature
timeFrame: before to 30 minutes after treatment
measure: colour/pigmentation
timeFrame: before to 30 minutes after treatment
measure: trans epidermal water loss
timeFrame: before to 30 minutes after treatment
measure: reduction of the bacterial load
timeFrame: directly to 5 minutes after treatment
Other outcomes:
Locations:
city: Beverwijk
country: Netherlands
facility: Association of Dutch Burn Centres
state: Noord-Holland
Study officials:
affiliation: Red Cross Hospital
name: Esther Middelkoop, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Brehmer 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.