Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00203489
Status:
TERMINATED
Last Update Posted:
2007-11-19
First Post:
2005-09-12
Brief Title:
A Clinical Study of An Antimicrobial Gauze Dressing
Sponsor:
Tyco Healthcare Group
Organization:
Tyco Healthcare Group
Study Overview
Official Title:
A Prospective Randomized Double-Blind Trial of a Polyhexamethylene Biguanide PHMB Impregnated Gauze Dressing for the Prevention of Chronic Wound Colonization With Resistant and Prevalent Microorganisms
Status:
TERMINATED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Reallocation of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if a new antimicrobial gauze dressing is better than the current method of dressing open wounds with plain sterile gauze It is hoped that the antimicrobial gauze will reduce the number of germs in the open wound and even improve the rate of healing
Detailed Description:
Without adequate debridement chronically infected wounds persist and form a nidus for the acquisition of antimicrobial-resistant microorganisms Multiple studies state that patients with chronic wounds were colonized with one or more resistant bacteria and that the presence of a chronic wound or decubitus ulcer was associated with a statistically increased likelihood of colonization with methicillin-resistant Staphylococcus aureus MRSA ciprofloxacin-resistant gram-negative bacilli GNBcolonization and infection with ceftazidime-resistant Escherichia coli and Klebsiella pneumoniae
Recently a newly formulated gauze dressing impregnated with an antiseptic agent has become available This product offers the promise of a combined benefit of wet-to-dry mechanical debridement while providing high local concentrations of a potent antiseptic to prevent colonization and infection of the wound by resistant microorganisms potentially enhancing wound healing
This study proposes to determine if use of the antimicrobial gauze in routine wound care results in a lower rate of chronic wound colonization with resistant microorganisms and prevalent microorganisms as compared to standard wound care with non-antimicrobial gauze
Recently a newly formulated gauze dressing impregnated with an antiseptic agent has become available This product offers the promise of a combined benefit of wet-to-dry mechanical debridement while providing high local concentrations of a potent antiseptic to prevent colonization and infection of the wound by resistant microorganisms potentially enhancing wound healing
This study proposes to determine if use of the antimicrobial gauze in routine wound care results in a lower rate of chronic wound colonization with resistant microorganisms and prevalent microorganisms as compared to standard wound care with non-antimicrobial gauze
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