Hard-to-heal wounds, such as venous leg ulcers (VLUs), are a major challenge to healthcare systems globally5
- Estimated prevalence of ~1.9 per 1000 population6,7
- Associated with reduced patient health-related quality of life and substantial economic burden8,9
Biofilm has long been implicated in hard-to-heal wounds10
- At least 78% of hard-to-heal wounds are estimated to have biofilm11
- Biofilm can protect microorganisms from antibiotics, antiseptics and host immunity10
PRIMARY
- Complete wound closure of week 12 (100% surface epithelialization)
SECONDARY
- Percent change in wound area (week 4 & 12)
- Satisfactory clinical progress (40% wound area reduction at week 4)
EXPLORATORY
- Time to complete wound closure
SAFETY
- Adverse events (AEs)
- Device-related AEs
- The mean wound area was 10.2cm2 in Aquacel® Ag+ Extra™ arm compared with 17.32 in the DACC arm.
- In Aquacel® Ag+ Extra™ arm, six patients had wound infection at baseline (no patients in the DACC arm had infection).
- Exudate volume on both arms were recorded evenly.
- Majority of tissue type in both arms is slough/fibrin and healthy granulation.
- Aquacel® Ag+ Extra™ was associated with statistically significantly increased rate of complete wound closure at week 12 compared to DACC dressings, as well we a faster time to complete wound closure
- VLUs treated with Aquacel® Ag+ Extra™ had a 35% increased likelihood of complete wound closure compared to DACC dressings at 12 weeks
- Aquacel® Ag+ Extra™ a resulted in a significantly greater percentage reduction in wound area compared to DACC dressings.
- Aquacel® Ag+ Extra™ was a safe treatment option with no serious of concern dressing-related AEs
- Improved quality of life (QoL) with significantly higher rate of satisfactory clinical progress13
- Aquacel® Ag+ Extra™ a had a 19% increased likelihood of satisfactory clinical progress compared to DACC dressings