Ignite Creation Date:
2024-05-06 @ 9:32 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03007264
Status:
COMPLETED
Last Update Posted:
2018-08-20
First Post:
2016-12-23
Brief Title:
Cold Plasma for Wound Treatment Safety Study
Sponsor:
Association of Dutch Burn Centres
Organization:
Association of Dutch Burn Centres
Study Overview
Official Title:
Safety Assessment of Cold Gas Plasma on Intact Skin
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NL5221109416 | OTHER | ABR | None |