Cold Plasma for Wound Treatment, Safety Study

Phase 1

Completed

• Conditions: Contaminant Given to Patient; Intact Skin
• Interventions: Device: Cold Atmospheric Plasma

• Registration Number: NCT03007264
• Lead Sponsor: Association of Dutch Burn Centres

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.

Study Timeline

• Study First Submitted: 2016-12-23
• Study First Submitted QC: 2016-12-29
• Study First Posted: 2017-01-02
• Status Verified: 2018-06
• Study Start: 2018-06-18
• Primary Completion: 2018-07-12
• Study Completion: 2018-07-26
• Last Update Submitted: 2018-08-17
• Last Update Posted: 2018-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CAP treated	Cold Atmospheric Plasma	volar arm will be treated with cold atmospheric plasma.
CAP on bacteria	Cold Atmospheric Plasma	volar arm with bacteria will be treated with cold atmospheric plasma.

Primary Outcome Measures

Name	Time	Method
pain	before to 30 minutes after treatment	by using a visual analogue thermometer (VAT)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Association of Dutch Burn Centres; 🇳🇱 Beverwijk, Noord-Holland, Netherlands