Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00618787
Recruitment Status : Completed
First Posted : February 20, 2008
Results First Posted : April 7, 2010
Last Update Posted : April 15, 2010
Sponsor:
Information provided by:
Tyco Healthcare Group

Brief Summary:
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 or disease Intervention/treatment Phase
Wounds Device: COPA AMD (note: name is not an acronym) Device: COPA (note: name is not an acronym) Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Prospective Randomized Double Blind Clinical Trial of Polyhexamethylene Biguanide Impregnated Foam Dressing
Study Start Date : February 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Prevalence of Signs of Critical Colonization, Deep Infection, and Wound Healing Between the Two Groups [ Time Frame: 5 weeks ]
  2. Percentage Change in Wound Surface Area (cm2) at Week 4 Compared to Week 0. [ Time Frame: Weeks 0 and 4 ]
    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 :
  1. Pain [ Time Frame: 5 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00618787


Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: R. Gary Sibbald, MD Community Dermatology and Wound Healing Clinic, Women's College Hospital- Dermatology Daycare & Wound Healing Clinic

Layout table for additonal information
Responsible Party: Tonya Eggleston, RN, MPH, Study Director, Tyco Healthcare Group
ClinicalTrials.gov Identifier: NCT00618787     History of Changes
Other Study ID Numbers: 360.18
First Posted: February 20, 2008    Key Record Dates
Results First Posted: April 7, 2010
Last Update Posted: April 15, 2010
Last Verified: April 2010
Additional relevant MeSH terms:
Layout table for MeSH terms
Biguanides
Polihexanide
Hypoglycemic Agents
Physiological Effects of Drugs
Disinfectants
Anti-Infective Agents