Ignite Creation Date:
2024-05-06 @ 3:10 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02228122
Status:
COMPLETED
Last Update Posted:
2015-12-02
First Post:
2014-08-26
Brief Title:
The Effect of Aquacel Ag Extra Dressing on Wound Biofilms
Sponsor:
Dr Angela Oates
Organization:
University of Manchester
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2015-12
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:
The purpose of the research is to assess the effects of Aquacel Ag Extra dressing on chronic wound bacterial biofilms
Detailed Description:
Background Chronic wounds and wound infections can be costly resulting in prolonged hospital stays and an increased risk of secondary infection and septicaemia In the UK the management of chronic venous leg ulcers is estimated to cost 1 billionyear with surgical site infections requiring approximately 65 days additional hospital stay Chronic wounds typically harbour a wide variety of bacteria heavy bacterial colonisation and subsequent biofilm formation has been cited as a factor which induces a chronic inflammatory state and delays healing times
AQUACELAg Extra is a soft conformable flat sheet nonwoven fabric dressing which forms a gel when it becomes wet Its physical characteristics have the potential to increase the speed of antimicrobial action of silver and its effectiveness against any recalcitrant wound bioburden Removing these potential barriers to healing may help towards wound progression
Aim This is a pilot study to investigate the effects of Aquacel Ag Extra dressing on chronic wound bacterial biofilms Wound debridement tissue will be assessed for the presenceabsence of in situ biofilms which will be monitored over 4 weeks and compared to the baseline non-treatment sample Additionally we will evaluate reductions in wound volume over the treatment period
AQUACELAg Extra is a soft conformable flat sheet nonwoven fabric dressing which forms a gel when it becomes wet Its physical characteristics have the potential to increase the speed of antimicrobial action of silver and its effectiveness against any recalcitrant wound bioburden Removing these potential barriers to healing may help towards wound progression
Aim This is a pilot study to investigate the effects of Aquacel Ag Extra dressing on chronic wound bacterial biofilms Wound debridement tissue will be assessed for the presenceabsence of in situ biofilms which will be monitored over 4 weeks and compared to the baseline non-treatment sample Additionally we will evaluate reductions in wound volume over the treatment period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None