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

Tyco Healthcare Group

Status and phase

Completed

Phase 2

Conditions

Wounds

Treatments

Device: COPA AMD (note: name is not an acronym)

Device: COPA (note: name is not an acronym)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00618787

360.18

Details and patient eligibility

About

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.

Enrollment

45 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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