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
Management of VLUs with Aquacel® Ag+ Extra™ versus DACC dressings was associated with
- Significantly better complete wound closure rate (74.8%) at week 12
- Significantly shorter wound closure time in 56 days
- Significantly greater percentage (85.2%) reduction in wound area
- Significantly higher rate (77.1%) of satisfactory clinical progress
- Lower incidence of AEs
- Improved QoL13
BEC*, a surfactant, reduces the surface tension to enhance the anti-biofilm performance of Aquacel® Ag+ Extra™ dressing.14,15,16
EDTA, A metal chelating agent, EDTA helps disrupt biofilm by removing metal ions that hold the EPS matrix together to expose microorganisms to the antimicrobial effects of the ionic silver.15,17,18,19
IONIC SILVER, A broad-spectrum antimicrobial contained in a safe and effective quantity (1.2%) ensures cell death of the exposed bacteria by damaging the DNA, denaturing proteins and enzymes, and interfering with protein synthesis.4,20,21
Developing MORE THAN SILVERTM technology involved researching a wide range of biofilm-disrupting agents and surfactants in combination with ionic silver.4
Not all claims are supported in all regulatory geographies.
1.Beraldo S. et al. Effectiveness of an enhanced silver-containing dressing in hard-to-heal venous leg ulcers: a randomised controlled trial. Journal of Wound Care, 2025.
2.Meredith K, et al. Assessment of the Antibiofilm Performance of Silver-Containing Wound Dressings: A Dual-Species Biofilm Model. Cureus. 2024;16(9):e70086.
3.Meredith et al. Assessment of Silver-Containing Gelling Fiber Dressings Against Antibiotic-Resistant Pathogens Using an in vitro Biofilm Model. Infect Drug Resist. 2023 Nov 2;16:7015-7019.
4.Bowler PG & Parsons D. Combatting wound biofilm and recalcitrance with a novel anti-biofilm Hydrofiber® wound dressing. Wound Medicine 14 (2016) 6–11.
5.Rice JB et al. Burden of diabetic foot ulcers for medicare and private insurers. Diabetes Care 2014;37(3):651–658.
6.Martinengo L et al. Prevalence of chronic wounds in the general population: systematic review and meta-analysis of observational studies. Ann Epidemiol 2019;29:8–15.
7.Sen CK. Human Wound and Its Burden: Updated 2020 Compendium of Estimates. Adv Wound Care (New Rochelle) 2021;10(5):281–292.
8.Olsson M et al. The humanistic and economic burden of chronic wounds: A systematic review. Wound Repair Regen 2019;27(1):114–125.
9.Chan B et al. Cost-of-illness studies in chronic ulcers: a systematic review. J Wound Care 2017;26(Suppl 4):S4–S14.
10.James GA et al. Biofilms in chronic wounds. Wound Repair Regen 2008;16(1):37–44.
11.Malone M et al. The prevalence of biofilms in chronic wounds: a systematic review and meta-analysis of published data. J Wound Care 2017;26(1):20–25.
12.1708881v1 Instruction for Use, Convatec.
13.WC-22-435 clinical study report, Convatec 2024.
14.Parsons. Composition comprising antimicrobial metal ions and a quaternary cationic surfactant. WO2012136968A1.
15.Murphy et al. International consensus document. Embedding Wound Hygiene into a proactive wound healing strategy. J Wound Care 2022;31:S1–S24.
16.Hall-Stoodley L I et al. Towards diagnostic guidelines for biofilm-associated infections. FEMS Immunol Med Microbiol. 2012; 65:127–145.
17.Wolcott RD et al. Biofilm maturity studies indicate sharp debridement opens a time dependent therapeutic window. J Wound Care. 2010 Aug;19(8):320-8.
18.Banin et al. Chelator-Induced Dispersal and Killing of Pseudomonas aeruginosa Cells in Biofilm. Appl. Environ. Microbiol 2006; 72: 2064-2069.
19.Finnegan & Percival. EDTA: an antimicrobial and antibiofilm agent for use in wound care. Adv Wound Care (New Rochelle) 2015; 4: 415–421.
20.Lansdown. Silver 1: Its antibacterial properties and mechanisms of action. J Wound Care 2002; 11: 125-130.
21.Lansdown. The role of silver. Eur Tissue Rep Soc 2002; 9: 108-111.
*BEC, benzethonium chloride
AP-73302-GBL-ENG-v1
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