Wounds Clinical Trial
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
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.
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).
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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