Wounds
Conditions
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.
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
Sponsors
Tyco Healthcare Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Weeks 0 and 4 | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Pain | 5 weeks |
Countries
Canada
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| COPA AMD Foam dressing impregnated with Polyhexamethylene Biguanide | 22 |
| COPA Regular foam dressing without Polyhexamethylene Biguanide | 23 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | COPA | COPA AMD | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 6 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 16 Participants | 37 Participants |
| Age Continuous | 55.1 years STANDARD_DEVIATION 11.01 | 56.4 years STANDARD_DEVIATION 15.28 | 55.8 years STANDARD_DEVIATION 13.13 |
| Region of Enrollment Canada | 23 participants | 22 participants | 45 participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 8 Participants |
| Sex: Female, Male Male | 20 Participants | 17 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 22 | 9 / 23 |
| serious Total, serious adverse events | 0 / 22 | 2 / 23 |
Outcome results
Primary
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
Population: Per protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| COPA AMD | Percentage Change in Wound Surface Area (cm2) at Week 4 Compared to Week 0. | 34.9 Percentage change |
| COPA | Percentage Change in Wound Surface Area (cm2) at Week 4 Compared to Week 0. | 27.8 Percentage change |
Primary
Prevalence of Signs of Critical Colonization, Deep Infection, and Wound Healing Between the Two Groups
Time frame: 5 weeks
Secondary
Pain
Time frame: 5 weeks