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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: April 2009

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: Arm 1
  • Active Comparator: Arm 2

Clinical Trial Outcome Measures

Primary Measures

  • Prevalence of Signs of Critical Colonization, Deep Infection, and Wound Healing Between the Two Groups
    • Time Frame: 5 weeks
  • 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 Measures

  • Pain
    • Time Frame: 5 weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tyco Healthcare Group
  • Provider of Information About this Clinical Study
    • Tonya Eggleston, RN, MPH, Study Director, Tyco Healthcare Group
  • Overall Official(s)
    • R. Gary Sibbald, MD, Principal Investigator, Community Dermatology and Wound Healing Clinic, Women’s College Hospital- Dermatology Daycare & Wound Healing Clinic

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