Prospective Randomized Double Blind Clinical Trial of Polyhexamethylene Biguanide Impregnated Foam Dressing

This study is currently recruiting participants.

Verified by Tyco Healthcare Group, December 2008

Sponsored by:	Tyco Healthcare Group
Information provided by:	Tyco Healthcare Group
ClinicalTrials.gov Identifier:	NCT00618787

Purpose

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

U.S. FDA Resources

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

Further study details as provided by Tyco Healthcare Group:

Primary Outcome Measures:

To compare the prevalence of signs of critical colonization, deep infection, and wound healing between the two groups [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare bacterial bioburden and localized wound pain [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

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

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

subject is 18 to 85 years of age inclusive
subject has a foot ulcer
subject has a leg ulcer
subject has an open wound of at 1.0 cm (2)
subject has one of the following: Palpable pulse, ABI > 0.56 or toe pressure > 50 mmHg
subject or legally authorized rep is able to understand and willing to give written informed consent

Exclusion Criteria:

subject has an allergy to Chlorhexidine Gluconate (CHG)
subject has open wounds that in the opinion of the Principal Investigator do not have the ability to heal
subject has current malignant disease or history of malignant disease in past 5 years
subject has inability to comply with the study protocol and procedures
subjects who require use of topical agents other than the impregnated or regular foam dressings dressings

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00618787

Contacts

Contact: Patricia Coutts, RN

905-273-9009 ext 22

Locations

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

Sponsors and Collaborators

Tyco Healthcare Group

Investigators

Principal Investigator:

R. Gary Sibbald, MD

Community Dermatology and Wound Healing Clinic, Women's College Hospital- Dermatology Daycare & Wound Healing Clinic

More Information

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

Study placed in the following topic categories:

Polyhexamethylene biguanide

Additional relevant MeSH terms:

Anti-Infective Agents
Disinfectants
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009