Leg Ulcers
Conditions
Brief summary
The purpose of this study is to compare the ability of Aquacel® Ag and Mepilex® Border Ag to manage bioburden in leg ulcers over a two week study period.
Interventions
DEVICEAquacel® Ag
Dressing will be changed during the clinic visit on day 3, 7 and 14. In between the clinic visits the dressing should be changed when needed depending on the clinical condition of the wound and the volume of exudate.
DEVICEMepilex® Border Ag
Dressing will be changed during the clinic visit on day 3, 7 and 14. In between the clinic visits the dressing should be changed when needed depending on the clinical condition of the wound and the volume of exudate.
Sponsors
ConvaTec Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 years or over * Willing and able to provide written informed consent * Leg ulcer will be of size ranging between 10 cm2 - 40 cm2 with moderate or heavy exudate * Leg ulcer will exhibit at least 2 of the 4 following clinical signs: pain between 2 dressing changes, peri-ulcer skin erythema, oedema, foul odour
Exclusion criteria
* Known skin sensitivity to any component of the products being tested * Subjects who have had current local or systemic antibiotics and/or topical antimicrobials applied in the week prior to inclusion * Depth of ulcer classified as superficial (not involving dermis) or deep (exposing muscle and tendon) * Any other medical condition which, according to the investigator, justifies the subject's exclusion from the study * Participated in a clinical study within the past 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microbial load reduction | Days 1 and 14 | The relative reduction from baseline in microbial load (bio-burden) over a 2 week study period as measured by quantitative and qualitative microbiology methods. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical evolution of the wound (presence of each of the selected clinical signs) | Days 1, 3, 7, 14 | Study's clinical signs: level of exudate (moderate or heavy at baseline), pain between 2 dressing changes, peri-ulcer skin erythema, oedema, foul odour |
| Occurrence of adverse events | Day 1-14 | — |
Countries
United Kingdom
Outcome results
None listed