Status:
TERMINATED
A Clinical Study of An Antimicrobial Gauze Dressing
Lead Sponsor:
Tyco Healthcare Group
Conditions:
Wounds
Eligibility:
All Genders
18+ years
Phase:
NA
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 g...
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 woun...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2007
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00203489
Start Date
June 1 2005
End Date
August 1 2007
Last Update
November 19 2007
Active Locations (1)
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1
Sunnybrook & Women's College Health Sciences Centre
Toronto, Ontario, Canada, M5S 1B2