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Completed

NCT Number: NCT00618787

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

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.

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Key information

Conditions

Wounds Wounds and Injuries

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Community Dermatology and Wound Healing Clinic, Mississauga, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COPA AMD (note: name is not an acronym)

Device

Foam dressing impregnated with Polyhexamethylene Biguanide

COPA (note: name is not an acronym)

Device

Regular foam dressing without PHMB

Primary outcomes

  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 outcomes

  1. Pain

    Time frame: 5 weeks

Sponsors and collaborators

Lead sponsor

Tyco Healthcare Group

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 20, 2008
Registry last updated
Apr 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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