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

Wounds Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00618787
• Other study ID #: 360.18
• Status: Completed
• Phase: Phase 2
• First received: January 10, 2008
• Last updated: April 9, 2010
• Start date: February 2008
• Est. completion date: April 2009

Study information

• Verified date: April 2010
• Source: Tyco Healthcare Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Wounds

Intervention

Device:
• COPA AMD (note: name is not an acronym)
Foam dressing impregnated with Polyhexamethylene Biguanide
• COPA (note: name is not an acronym)
Regular foam dressing without PHMB

Locations

Country	Name	City	State
Canada	Community Dermatology and Wound Healing Clinic	Mississauga	Ontario
Canada	Women's College Hospital; Dermatology Daycare & Wound Healing Clinic	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Tyco Healthcare Group

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of Signs of Critical Colonization, Deep Infection, and Wound Healing Between the Two Groups		5 weeks	No
Primary	Percentage Change in Wound Surface Area (cm2) at Week 4 Compared to Week 0.	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.	Weeks 0 and 4	No
Secondary	Pain		5 weeks	No