Cold Plasma for Wound Treatment, Safety Study

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.

Study Overview

• Status: Completed
• Conditions: Intact Skin; Contaminant Given to Patient
• Intervention / Treatment: Device: Cold Atmospheric Plasma

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Holland
    • Beverwijk, Noord-Holland, Netherlands, 1942 LE
      • Association of Dutch Burn Centres

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CAP treated; volar arm will be treated with cold atmospheric plasma.	Device: Cold Atmospheric Plasma; CAP will be applied on one volar arm of volunteers for a total of 2 minutes.
EXPERIMENTAL: CAP on bacteria; volar arm with bacteria will be treated with cold atmospheric plasma.	Device: Cold Atmospheric Plasma; CAP will be applied on one volar arm of volunteers for a total of 2 minutes.
NO_INTERVENTION: no CAP on bacteria; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain	by using a visual analogue thermometer (VAT)	before to 30 minutes after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
local skin reaction	blister formation, itching	directly to 30 minutes after treatment
local skin temperature	thermographic analysis	before to 30 minutes after treatment
colour/pigmentation	erythema, redness of the skin, by using a Dermaspectrometer	before to 30 minutes after treatment
trans epidermal water loss	barrier function of the skin by using TEWAmeter	before to 30 minutes after treatment
reduction of the bacterial load	quantified with scrub wash method	directly to 5 minutes after treatment

Collaborators and Investigators

• Sponsor: Association of Dutch Burn Centres
• Collaborators: Eindhoven University of Technology
• Investigators: Principal Investigator: Esther Middelkoop, PhD, Red Cross Hospital

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 18, 2018
• Primary Completion (ACTUAL): July 12, 2018
• Study Completion (ACTUAL): July 26, 2018

Study Registration Dates

• First Submitted: December 23, 2016
• First Submitted That Met QC Criteria: December 29, 2016
• First Posted (ESTIMATE): January 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 20, 2018
• Last Update Submitted That Met QC Criteria: August 17, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: pain; bacteria; skin parameters; cold atmospheric plasma
• Other Study ID Numbers: NBS 14.200-CAP1; NL52211.094.16 (OTHER: ABR)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No