Comparing a Foam Composite to a Hydrocellular Foam Dressing in the Management of Venous Leg Ulcers: A Controlled Clinical Stud
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V enous leg ulcers are the most prevalent form of chronic wounds in the Western world, accounting for 45% to 60% of all chronic leg ulcers and occurring in 1% to 2% of people 65 years old and older in some countries.1 Most venous ulcers are not the result of external causes but arise from venous insufficiency that compromises return of venous blood to the heart. The clinical picture is characterized by alternating phases of ulceration and transitory healing. Despite recent advances in wound care, ulcers can take months to heal, have frequent complications (eg, infections and cellulitis), often recur, and are costly to treat.2 The refractory nature of venous leg ulcers can affect a patient’s quality of life and productivity at work, causing significant morbidity.3
Managing venous leg ulcers poses an enormous financial burden associated with diagnostic tests, nursing care, and rehabilitation. An estimated 2 million working days are lost per year in the US4 as a result of this condition. Although lower extremity ulcers are the most commonly occurring chronic wounds, many healthcare providers do not appreciate how to manage these wounds cost-effectively in an outpatient setting,5 and non-specialists in wound care are not always conversant with the information available on best practice.6
Currently, the standard of care consists of local wound management combined with compression bandaging to reduce edema and promote venous return.2 The principles of moist wound healing7-9 coupled with graduated compression bandaging10-12 have become the cornerstone of treatment for leg ulcers. Modern wound dressings have an increased capacity for managing exudate (and its potentially pathogenic bioburden), reducing the need for frequent dressing changes, protecting the surrounding skin, decreasing odor from wounds, and diminishing pain between and during dressing changes.
Dressings may differ in their ability to meet patient and caregiver needs. A recently developed foam composite (FC) dressing was designed to utilize the benefits of combining a hydrocolloid adhesive with a Hydrofiber® primary dressing covered with a foam secondary dressing. Non-comparative pilot research using this FC dressing13 for 5 weeks or up to 10 dressing changes resulted in marked improvement or healing of 82% of 11 leg ulcers with an average wear time approaching 5 days. Dressing changes produced little or no trauma and patients reported that discomfort did not occur or was negligible. Both hydrocellular foam (F) and FC dressings create a moist wound-healing environment, but their physical properties and construction differ. To date, no prospective randomized controlled trials have explored differences between the clinical performance of these two types of dressings. The purpose of this study was to compare the performance of these two foam dressings in the management of venous ulcers.
Materials and Methods
A prospective, stratified, randomized, comparative, multicenter study design was used to compare the two dressings at 15 sites in North America and Europe for a maximum study duration of 12 weeks. The sites included nine hospital outpatient or physician office-based clinics in the US, one physician office-based clinic and one hospital clinic in Germany, two community care agencies in the UK, and one physician office-based clinic each in Canada and France. Patients were randomly assigned to receive a protocol of care which included one of two foam primary dressings covered with a compression bandage.
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