Clinical Study of Venous Leg Ulcers Shows Substantial Wound Improvements with Biofilm-Fighting AQUACEL® Ag+ Dressing
88.1% of wounds observed either improved or healed completely after 8 weeks1
LUXEMBOURG (Sept. 8, 2015)—Recently published results of a clinical study showed substantial wound improvements with AQUACEL™ Ag+ wound dressing in difficult-to-treat venous leg ulcers, including those compromised by infection. Results of the study were published online in The International Wound Journal.1
AQUACEL™ Ag+ dressings have been designed to disrupt biofilm and kill infection-causing bacteria in the wound dressing.*2-4 Biofilms are formed when colonies of surface-attached bacteria secrete a slime to protect themselves.5 They are believed to exist in the majority of chronic wounds6, are difficult to disrupt7, and can reform quickly8. Biofilm contributes to adverse patient outcomes that include delayed healing9, and may be a precursor to clinical infection.10
In the study, AQUACEL™ Ag+ dressing was used for four weeks on 42 patients with venous leg ulcers exhibiting clinical signs of infection, followed by four weeks of management with AQUACEL™ wound dressing. By the end of the study:
- 88.1% of all wounds either improved or healed completely1
- Mean ulcer size had decreased by 54.5%1
- Patients reported less pain as the study progressed.1
Ten of the 42 patients had wounds that were considered most severe (i.e., clinically infected and requiring treatment with systemic antibiotics or topical antimicrobials). By the end of the study, all of these wounds had shown improvement, and the mean ulcer size in this group had decreased by 70.2%.1
“Biofilm is now well recognized as a key cause of delayed wound healing and a precursor to infection,” said Keith Harding, Dean of Clinical Innovation, Wound Healing Unit, Cardiff University School of Medicine, UK. “The results seen with AQUACEL™ Ag+ dressing provide an encouraging option for facilitating wound healing in patients with difficult-to-treat, chronic venous leg ulcers.”
“The results of this evaluation are very encouraging in that, in addition to demonstrating product safety, they provide good indication of the ability of this product to promote healing in previously static and/or infected chronic wounds,” added Phil Bowler, Vice President of Science and Technology, ConvaTec. “The results in clinically infected wounds are particularly promising, as these types of recalcitrant wounds put an additional burden on healthcare costs and resources.”
About the Study
The study, supported by ConvaTec, was a non-comparative controlled study to assess the safety and performance of AQUACEL™ Ag+ dressing in the management of chronic venous leg ulcers. In this clinical trial, expert Clinical Investigators recruited 42 subjects with challenging or infected leg ulcers from six study centers in the UK and Poland.
Each leg ulcer covered an area of between 5 and 40 cm2, and met at least three of five pre‑defined clinical signs of infection. In addition, ulcers were categorized at baseline as either clinically infected or not clinically infected. Allocation to these two groups was based on the judgment of individual clinicians following consideration of the wound history and presentation at the time of enrolment, and the severity associated with each of the clinical signs of infection.
The Clinical Investigation Plan and supporting documents were reviewed and approved by the appropriate country-specific ethics and appropriate notified bodies. This research was carried out in accordance with ISO14155:2011.
About AQUACEL™ Ag+ Dressings
AQUACEL™ Ag+ dressings are designed to address three key barriers to wound healing: excess exudate, infection and biofilm. AQUACEL™ Ag+ dressings combine ConvaTec’s proprietary Hydrofiber™ Technology with Ag+ Technology. As demonstrated in vitro, Hydrofiber™ Technology absorbs and retains excess exudate to help create an ideal healing environment.12-16 AQUACEL™ Ag+ Technology has been developed to maximize the antimicrobial action of ionic silver*17, which has been shown in vitro to kill a broad spectrum of bacteria, including antibiotic-resistant superbugs.3,4,18
The family of AQUACEL™ Ag+ dressings includes AQUACEL™ Ag+ Extra™ dressing and AQUACEL™ Ag+ ribbon dressing for tunneling wounds. AQUACEL™ Ag+ dressings received CE mark approval in 2013 and are available in select countries in the European Union, as well as Canada, Hong Kong and Malaysia. AQUACEL™ Ag+ dressings are investigational devices within the U.S. which are limited by U.S. federal law to investigational use and not yet available for commercial sale.
ConvaTec is a global medical products and technologies company, with leading market positions in wound therapeutics, ostomy care, continence and critical care, and infusion devices. Its products provide a range of clinical and economic benefits, including infection prevention, protection of at-risk skin, improved patient outcomes, and reduced total cost of care. ConvaTec has over 9,000 employees, with 11 manufacturing sites in 8 countries, and does business in more than 100 countries. ConvaTec is owned by Nordic Capital and Avista Capital Partners.
*As demonstrated in vitro
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®/™ indicates trademarks of ConvaTec Inc.
© 2015 ConvaTec Inc.
- Harding K, Szczepkowski M, Mikosinski J, Twardowska-Saucha K, Blair S, Ivins N, Saucha W, Cains J, Peters K, Parsons D, Bowler P, 2015. Safety and Performance Evaluation of a Next Generation Antimicrobial Dressing in Patients with Chronic Venous Leg Ulcers. International Wound Journal; http://onlinelibrary.wiley.com/enhanced/doi/10.1111/iwj.12450/
- Physical Disruption of Biofilm by AQUACEL® Ag+ Wound Dressing. Scientific Background Report. WHRI3850 MA232, 2013, Data on file, ConvaTec Inc.
- Antimicrobial activity and prevention of biofilm reformation by AQUACEL™ Ag+ EXTRA dressing. Scientific Background Report. WHRI3857 MA236, 2013, Data on file, ConvaTec Inc.
- Antimicrobial activity against CA-MRSA and prevention of biofilm reformation by AQUACEL™ Ag+ EXTRA dressing. Scientific Background Report. WHRI3875 MA239, 2013, Data on file, ConvaTec Inc.
- Bjarnsholt T, 2013. The role of bacterial biofilms in chronic infections. APMIS; 121: 1-51.
- James G, Swogger E, Wolcott R, Pulcini E, Secor P, et al. 2008. Biofilms in chronic wounds. Wound Repair and Regeneration; 16:37-44.
- Wolcott R, Rumbaugh K, James G, Schultz G, Phillips P, Yang O, et al 2010. Biofilm maturity studies indicate sharp debridement opens a time-dependent therapeutic window. J Wound Care; 19: 320-328.
- Wolcott R, Kennedy J, Dowd S, 2009. Regular debridement is the main tool for maintaining a healthy wound bed in most chronic wounds. J Wound Care; 18:54-56.
- Metcalf D and Bowler P, 2013. Biofilm delays wound healing: a review of the evidence. Burns & Trauma;1:5-12
- Percival SL, Bowler PG, 2004. Biofilms and their potential role in wound healing. WOUNDS, 16: 234-240.
- Harding K, Posnett J, Vowden K, 2012. A new methodology for costing wound care. Int Wound J.; 10: 623–9.
- Newman G, Walker M, Hobot J, Bowler P, 2006. Visualisation of bacterial sequestration and bacterial activity within hydrating Hydrofiber™ wound dressings. Biomaterials; 27: 1129-1139.
- Walker M, Hobot J, Newman G, Bowler P, 2003. Scanning electron microscopic examination of bacterial immobilization in a carboxymethyl cellulose (AQUACEL™) and alginate dressing. Biomaterials; 24: 883-890.
- Bowler P, Jones S, Davies B, Coyle E, 1999. Infection control properties of some wound dressings. J. Wound Care; 8: 499-502.
- Walker M, Bowler P, Cochrane C, 2007. In vitro studies to show sequestration of matrix metalloproteinases by silver-containing wound care products. Ostomy/Wound Management; 53: 18-25.
- Assessment of the in vitro Physical Properties of AQUACEL EXTRA, AQUACEL Ag EXTRA and AQUACEL Ag+ EXTRA dressings. Scientific background report. WHRIA3817 TA297, 2013, Data on file, ConvaTec Inc.
- Said J, Walker M, Parsons D, Stapleton, P., Beezer, A., Gaisford, S. An in vitro test of the efficacy of an anti-biofilm wound dressing. International Journal of Pharmaceutics, 2014; 474, 177-181.
- Bowler P, Welsby S, Towers V, Booth V, Hogarth A, Rowlands V, Joseph A, et al, 2012. Multidrug-resistant organisms, wounds and topical antimicrobial properties. Int Wound J. 9: 387-396.