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

NCT00618787 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2010-04-15

Study results available
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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.

Conditions

  • Wounds

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

Sponsors & Collaborators

  • Tyco Healthcare Group

    lead INDUSTRY

Principal Investigators

  • R. Gary Sibbald, MD · Community Dermatology and Wound Healing Clinic, Women's College Hospital- Dermatology Daycare & Wound Healing Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00618787 on ClinicalTrials.gov