- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00203489
A Clinical Study of An Antimicrobial Gauze Dressing
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 Overview
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 (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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5S 1B2
- Sunnybrook & Women's College Health Sciences Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The subject is receiving care at the study wound care clinics.
- The subject is 18 years of age or older.
- The subject or authorized representative has signed the Informed Consent form.
- The subject has a chronic wound as a result of pressure ulceration (grade III and IV ulcers only), underlying vascular disease ("leg ulcer"), diabetes mellitus (grade 2 and 3 ulcers only), or recent surgery.
Exclusion Criteria:
- The subject has a chronic ulcer that is a result of a condition other than that defined in the inclusion criteria.
- The subject has stage I and II pressure ulceration.
- The subject has a superficial (grade 0 or 1) or limb-threatening diabetic foot ulceration (grade 4 or 5).
- The subject has a leg ulcer related to carcinoma.
- The subject is scheduled to go for amputation or surgical flap procedure as a result of an open wound.
- Subject is scheduled to receive a V.A.C.® (Vacuum Assisted Closure) Dressing [V.A.C.® (Vacuum Assisted Closure) Dressing KCI, Kinetic Concepts, Inc., San Antonio, TX].
- The subject has extensive burns or another acute diffuse skin condition (Stevens-Johnson Syndrome).
- The subject has a history of hypersensitivity to Chlorhexidine Gluconate (CHG) or Polyhexamethylene Biguanide (PHMB).
- The subject has severe systemic infection characterized by the systemic inflammatory response syndrome.
- The subject has taken part in a wound healing study within the past month.
- The subject has suspected or confirmed underlying osteomyelitis contiguous to the ulcer and is not receiving systemic antimicrobial therapy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Rate of chronic wound colonization with resistant/prevalent microorganisms.
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Secondary Outcome Measures
Outcome Measure |
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Rate of wound surface area healing over time; Antibiotic utilization.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Tonya M. Eggleston, RN, MPH, Tyco Healthcare/Kendall
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Study Protocol 331.18
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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