A Clinical Study of An Antimicrobial Gauze Dressing
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|ClinicalTrials.gov Identifier: NCT00203489|
Recruitment Status : Terminated (Reallocation of funding.)
First Posted : September 20, 2005
Last Update Posted : November 19, 2007
|Condition or disease||Intervention/treatment||Phase|
|Wounds||Device: KERLIX A.M.D. Gauze||Not Applicable|
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 (GNB),colonization 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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||June 2005|
|Study Completion Date :||August 2007|
- Rate of chronic wound colonization with resistant/prevalent microorganisms.
- Rate of wound surface area healing over time; Antibiotic utilization.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00203489
|Sunnybrook & Women's College Health Sciences Centre|
|Toronto, Ontario, Canada, M5S 1B2|
|Study Director:||Tonya M. Eggleston, RN, MPH||Tyco Healthcare/Kendall|