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

Phase 2

Completed

• Conditions: Wounds

• Registration Number: NCT00618787
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-01-10
• Study Start: 2008-02
• Study First Submitted QC: 2008-02-06
• Study First Posted: 2008-02-20
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Results First Submitted: 2009-07-29
• Status Verified: 2010-04
• Results First Submitted QC: 2010-04-05
• Results First Posted: 2010-04-07
• Last Update Submitted: 2010-04-09
• Last Update Posted: 2010-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage Change in Wound Surface Area (cm2) at Week 4 Compared to Week 0.	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.
Prevalence of Signs of Critical Colonization, Deep Infection, and Wound Healing Between the Two Groups	5 weeks

Secondary Outcome Measures

Name	Time	Method
Pain	5 weeks

Trial Locations

Locations (2)

Community Dermatology and Wound Healing Clinic; 🇨🇦 Mississauga, Ontario, Canada

Women's College Hospital; Dermatology Daycare & Wound Healing Clinic; 🇨🇦 Toronto, Ontario, Canada