NCT00618787

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Tyco Healthcare Group · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2008-02-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2008-02-20
• Last updated: 2010-04-15
• Results posted: 2010-04-07

Locations

2 sites across 1 country: Canada