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

NCT00618787 | Completed Phase 2 Results

• 1 other identifier: 360.18
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (2)

• Prevalence of Signs of Critical Colonization, Deep Infection, and Wound Healing Between the Two Groups

  5 weeks

• Percentage Change in Wound Surface Area (cm2) at Week 4 Compared to Week 0.

  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.

  Weeks 0 and 4

Secondary Outcomes (1)

• Pain

  5 weeks

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

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

Arm 2

ACTIVE COMPARATOR

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

Interventions

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

Foam dressing impregnated with Polyhexamethylene Biguanide

Arm 1

COPA (note: name is not an acronym) DEVICE

Regular foam dressing without PHMB

Arm 2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tyco Healthcare Group: lead

Study Sites (2)

Community Dermatology and Wound Healing Clinic

Mississauga, Ontario, L4Y 1A6, Canada

Location

Women's College Hospital; Dermatology Daycare & Wound Healing Clinic

Toronto, Ontario, M5S 1B2, Canada

Location

MeSH Terms

Conditions

Wounds and Injuries

Results Point of Contact

• Title: Tonya Eggleston, RN, MPH, Study Director
• Organization: Tyco Healthcare Group

Tonya.Eggleston@Covidien.com

(508) 261-8420

Study Officials

• R. Gary Sibbald, MD

  Community Dermatology and Wound Healing Clinic, Women's College Hospital- Dermatology Daycare & Wound Healing Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 10, 2008
• First Posted: February 20, 2008
• Study Start: February 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: April 15, 2010
• Results First Posted: April 7, 2010

Record last verified: 2010-04

Locations

CA (2)