NCT03007264

Cold Plasma for Wound Treatment, Safety Study

Safety Assessment of Cold Gas Plasma on Intact Skin

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Association of Dutch Burn Centres · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Intact Skin
• Contaminant Given to Patient

Interventions

Type	Name	Description
DEVICE	Cold Atmospheric Plasma	CAP will be applied on one volar arm of volunteers for a total of 2 minutes.

Timeline

• Start date: 2018-06-18
• Primary completion: 2018-07-12
• Completion: 2018-07-26
• First posted: 2017-01-02
• Last updated: 2018-08-20

Locations

1 site across 1 country: Netherlands