CompletedNCT00618787Updated Apr 15, 2010Results posted

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

A Phase 2 interventional study of COPA AMD (note: name is not an acronym) and COPA (note: name is not an acronym) in Wounds, sponsored by Tyco Healthcare Group. Completed at 2 sites in Canada. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2010-04-15.

Sponsored by Tyco Healthcare Group · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 45
Allocation: Randomized
Ages: 18 Years to 85 Years
Sex: All

Study 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 studied

Wounds

In context

Lead sponsor

Tyco Healthcare Group is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 45 participants (actual)

Study arms

Active comparator
Arm 1
Device: COPA AMD (note: name is not an acronym)
Active comparator
Arm 2
Device: COPA (note: name is not an acronym)

Interventions

DeviceCOPA AMD (note: name is not an acronym)
Foam dressing impregnated with Polyhexamethylene Biguanide
DeviceCOPA (note: name is not an acronym)
Regular foam dressing without PHMB

What researchers measure

Primary outcomes

Prevalence of Signs of Critical Colonization, Deep Infection, and Wound Healing Between the Two Groups
Time frame: 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.
Time frame: Weeks 0 and 4

Secondary outcomes

Pain
Time frame: 5 weeks

Results

Posted Apr 7, 2010

Participant flow

The first study subject was randomized on March 5, 2008 and the last subject visit was conducted on February 18, 2009. Subjects were screened for eligibility, consented, enrolled and randomized at two participating wound care clinics.

Participant flow — Overall Study
Milestone	COPA AMD	COPA
Started	22	23
Completed	19	21
Not completed	3	2
Withdrew: Adverse event	0	1
Withdrew: Withdrawal by subject	2	1
Withdrew: Lost to follow-up	1	0

Outcome measures

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

Time frame:: 5 weeks

Results for this outcome have not been posted.

SecondaryPain

Time frame:: 5 weeks

Results for this outcome have not been posted.

PrimaryPercentage 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.

Time frame:: Weeks 0 and 4
Reported as:: Median · Percentage change

Percentage Change in Wound Surface Area (cm2) at Week 4 Compared to Week 0.
Percentage change	COPA AMD	COPA
Percentage Change in Wound Surface Area (cm2) at Week 4 Compared to Week 0.	34.9 (-74.8 to 94.7)	27.8 (-167 to 97.6)

Adverse events

Collected over One year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
COPA AMD	—	0/22 (0%)	5/22 (22.7%)
COPA	—	2/23 (8.7%)	9/23 (39.1%)

Most frequent serious events

Most frequent serious events
Event	COPA AMD	COPA
cardiac stent implantedCardiac disorders	0/22	1/23
pulmonary embolusRespiratory, thoracic and mediastinal disorders	0/22	1/23

Most frequent other events

Most frequent other events
Event	COPA AMD	COPA
Head, eyes, ears, nose and throatEar and labyrinth disorders	2/22	0/23
Skin/Dermatologic (not including study wound)Skin and subcutaneous tissue disorders	2/22	2/23
Wound InfectionSkin and subcutaneous tissue disorders	0/22	2/23
Endocrine, metabolic and nutritionalMetabolism and nutrition disorders	1/22	0/23
Allergic and immunologicEndocrine disorders	0/22	1/23
MusculoskeletalMusculoskeletal and connective tissue disorders	0/22	1/23
Digestive/GastrointestinalGastrointestinal disorders	0/22	1/23
UrogenitalRenal and urinary disorders	0/22	1/23
Hematopoietic/LymphaticBlood and lymphatic system disorders	0/22	1/23

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	COPA AMD	COPA	Total
<=18 years	0	0	0
Between 18 and 65 years	16	21	37
>=65 years	6	2	8

Age Continuous
Age Continuous(years)	COPA AMD	COPA	Total
Mean	56.4 ± 15.28	55.1 ± 11.01	55.8 ± 13.13

Sex: Female, Male
Sex: Female, Male(Participants)	COPA AMD	COPA	Total
Female	5	3	8
Male	17	20	37

Region of Enrollment
Region of Enrollment(participants)	COPA AMD	COPA	Total
Canada	22	23	45

Study locations

2 sites

Community Dermatology and Wound Healing Clinic
Mississauga, Ontario L4Y 1A6, Canada
Women's College Hospital; Dermatology Daycare & Wound Healing Clinic
Toronto, Ontario M5S 1B2, Canada

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 15, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00618787
Lead sponsor: Tyco Healthcare Group
First posted: Feb 20, 2008
Start date: Feb 2008
Primary completion: Apr 2009
Completion: Apr 2009
Results posted: Apr 7, 2010
Last update: Apr 15, 2010

Study contacts

R. Gary Sibbald, MD

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

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Tyco Healthcare Group

Start the discussion