Prospective Randomized Double Blind Clinical Trial of Polyhexamethylene Biguanide Impregnated Foam Dressing - Full Text View

Sponsor:	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 (note: name is not an acronym) Device: COPA (note: name is not an acronym)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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:

Prevalence of Signs of Critical Colonization, Deep Infection, and Wound Healing Between the Two Groups [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Percentage Change in Wound Surface Area (cm2) at Week 4 Compared to Week 0. [ Time Frame: Weeks 0 and 4 ] [ Designated as safety issue: No ]
At each study visit, the subject's wound surface area was measured by longest length times widest width at right angles (LxW=cm2). Compiled data were analyzed to determine the median percentage decrease in wound surface area between groups and between study visits. Results report the median percentage decrease of the wound surface area as measured by cm2, comparing wound surface area at Week 4 to Week 0.

Secondary Outcome Measures:

Pain [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Enrollment:	45
Study Start Date:	February 2008
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Arm 1	Device: COPA AMD (note: name is not an acronym) Foam dressing impregnated with Polyhexamethylene Biguanide
Active Comparator: Arm 2	Device: COPA (note: name is not an acronym) 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

Locations

Canada, Ontario
Community Dermatology and Wound Healing Clinic
Mississauga, Ontario, Canada, L4Y 1A6
Women's College Hospital; Dermatology Daycare & Wound Healing Clinic
Toronto, Ontario, Canada, M5S 1B2

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

No publications provided

Responsible Party:	Tonya Eggleston, RN, MPH, Study Director, Tyco Healthcare Group
ClinicalTrials.gov Identifier:	NCT00618787 History of Changes
Other Study ID Numbers:	360.18
Study First Received:	January 10, 2008
Results First Received:	July 29, 2009
Last Updated:	April 9, 2010
Health Authority:	Canada: Health Canada

Additional relevant MeSH terms:

Polyhexamethylene biguanide
Disinfectants
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012