Phase 2 Completed N=45 Randomized Triple-blind Treatment

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

Source: ClinicalTrials.gov NCT00618787 ↗

Enrolled (actual)

Serious AEs

4.4%

Results posted

Apr 2010

Primary outcomePrimary: Prevalence of Signs of Critical Colonization, Deep Infection, and Wound Healing Between the Two Groups

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Prevalence of Signs of Critical Colonization, Deep Infection, and Wound Healing Between the Two Groups	—	—
PRIMARY Percentage Change in Wound Surface Area (cm2) at Week 4 Compared to Week 0.	34.9; 27.8	—
SECONDARY Pain	—	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00618787). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.