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Sponsored by: |
Tyco Healthcare Group |
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Information provided by: | Tyco Healthcare Group |
ClinicalTrials.gov Identifier: | NCT00618787 |
This is a multi-center, prospective, randomized, double blind, pilot clinical trial of subjects with chronic wounds. The purpose of this study is to compare the efficacy of COPA AMD PHMB Impregnated foam dressing compared to regular foam dressing in subjects with chronic wounds.
Condition | Intervention | Phase |
---|---|---|
Wounds |
Device: COPA AMD Device: COPA |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment |
Official Title: | Prospective Randomized Double Blind Clinical Trial of Polyhexamethylene Biguanide Impregnated Foam Dressing |
Estimated Enrollment: | 50 |
Study Start Date: | February 2008 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm 1: Active Comparator |
Device: COPA AMD
Foam dressing impregnated with Polyhexamethylene Biguanide
|
Arm 2: Active Comparator |
Device: COPA
Regular foam dressing without PHMB
|
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Patricia Coutts, RN | 905-273-9009 ext 22 |
Canada, Ontario | |
Community Dermatology and Wound Healing Clinic | Recruiting |
Mississauga, Ontario, Canada, L4Y 1A6 | |
Contact: Patricia Coutts, RN 905-273-9009 ext 22 | |
Women's College Hospital; Dermatology Daycare & Wound Healing Clinic | Recruiting |
Toronto, Ontario, Canada, M5S 1B2 | |
Contact: Kevin Woo, RN, MSc, PhD 416-323-6407 Kevin.Woo@wchospital.ca | |
Principal Investigator: R. Gary Sibbald, MD |
Principal Investigator: | R. Gary Sibbald, MD | Community Dermatology and Wound Healing Clinic, Women's College Hospital- Dermatology Daycare & Wound Healing Clinic |
Responsible Party: | Tyco Healthcare Group ( Tonya Eggleston, RN, MPH, Study Director ) |
Study ID Numbers: | 360.18 |
Study First Received: | January 10, 2008 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00618787 |
Health Authority: | Canada: Health Canada |
Polyhexamethylene biguanide |
Anti-Infective Agents Disinfectants Therapeutic Uses Pharmacologic Actions |