Cold Plasma for Wound Treatment, Safety Study

Intact Skin Clinical Trial

Official title:

Safety Assessment of Cold Gas Plasma on Intact Skin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03007264
• Other study ID #: NBS 14.200-CAP1
• Secondary ID: NL52211.094.16
• Status: Completed
• Phase: Phase 1
• Start date: June 18, 2018
• Est. completion date: July 26, 2018

Study information

• Verified date: June 2018
• Source: Association of Dutch Burn Centres
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The investigators expect this treatment to have a good antimicrobial effect with acceptable, transient skin sensations.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 26, 2018
• Est. primary completion date: July 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Contaminant Given to Patient
• Intact Skin

Intervention

Device:
• Cold Atmospheric Plasma
CAP will be applied on one volar arm of volunteers for a total of 2 minutes.

Locations

Country	Name	City	State
Netherlands	Association of Dutch Burn Centres	Beverwijk	Noord-Holland

Sponsors (2)

Lead Sponsor	Collaborator
Association of Dutch Burn Centres	Eindhoven University of Technology

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

Brehmer F, Haenssle HA, Daeschlein G, Ahmed R, Pfeiffer S, Görlitz A, Simon D, Schön MP, Wandke D, Emmert S. Alleviation of chronic venous leg ulcers with a hand-held dielectric barrier discharge plasma generator (PlasmaDerm(®) VU-2010): results of a mono — View 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.mv — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain	by using a visual analogue thermometer (VAT)	before to 30 minutes after treatment
Secondary	local skin reaction	blister formation, itching	directly to 30 minutes after treatment
Secondary	local skin temperature	thermographic analysis	before to 30 minutes after treatment
Secondary	colour/pigmentation	erythema, redness of the skin, by using a Dermaspectrometer	before to 30 minutes after treatment
Secondary	trans epidermal water loss	barrier function of the skin by using TEWAmeter	before to 30 minutes after treatment
Secondary	reduction of the bacterial load	quantified with scrub wash method	directly to 5 minutes after treatment