Compare Aquacel® Ag Versus Mepilex® Border Ag to Manage Bioburden in Leg Ulcers

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Multi-center, Randomized, Comparative Clinical Study to Compare Aquacel® Ag vs. Mepilex® Border Ag to Manage Bioburden in Leg Ulcers.

Conditions
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Leg Ulcers

Intervention / Treatment
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* Device: Aquacel® Ag
* Device: Mepilex® Border Ag


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aquacel® Ag<br> | Device: Aquacel® Ag<br>* 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.<br>|
| Active Comparator: Mepilex® Border Ag<br> | Device: Mepilex® Border Ag<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbial load reduction | The relative reduction from baseline in microbial load (bio-burden) over a 2 week study period as measured by quantitative and qualitative microbiology methods. | Days 1 and 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical evolution of the wound (presence of each of the selected clinical signs) | Study's clinical signs: level of exudate (moderate or heavy at baseline), pain between 2 dressing changes, peri-ulcer skin erythema, oedema, foul odour | Days 1, 3, 7, 14 | 
| Occurrence of adverse events |  | Day 1-14 |