A Prospective, Open-Label Study to Assess the Clinical Performance of a Foam Dressing in the Management of Chronic Wounds
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Treatment of patients with chronic wounds should address the underlying disease and the selection appropriate products, including the stage-adapted use of hydroactive wound dressings.1 It has been observed that hydroactive dressings (eg, hydrogels, polyurethane foams, and alginates) maintain moist wound conditions, which may encourage the migration of key cells (macrophages, keratinocytes, fibroblasts, and endothelial cells) that facilitate granulation and re-epithelialization.2 However, excessive wound fluid, burdened with excessive protease levels, has been shown to interfere with wound healing in in vivo clinical studies3 and it also has been noted that inappropriate control of wound exudate can lead to significant clinical problems, such as maceration of the surrounding skin, skin breakdown, wound enlargement, and increased pain.4 On the other hand, reviews suggest that if a wound is kept too dry, the healing process may be delayed and dressing changes more painful due to dressing adherence to the wound bed.5 Application of a dressing that can remove excessive wound exudate while retaining a moist environment that supports the healing process may help achieve the right balance of moisture to support the wound-healing process.5-7
Polyurethane foam dressings were introduced into clinical practice to facilitate maintenance of a moist wound environment and absorb excessive wound exudate.8 The foam dressing PermaFoam® Cavity (Paul Hartmann AG, Heidenheim, Germany) was developed for the management of medium to heavily exuding shallow as well as deep, cavernous wounds to absorb excessive exudate while retaining a moist wound environment. When folded, the dressing may be especially suited for packing wound cavities and deep ulcers, a frequent wound management challenge.
The purpose of this study was to assess the clinical performance, potential for supporting wound healing, and patient tolerance of this polyurethane foam dressing.
Materials and Methods
Outpatients with chronic, nonhealing or acute wounds of different etiologies in 15 German medical centers (seven physician-run, eight community nursing services were eligible to participate in the evaluation. No inclusion or exclusion criteria were provided, rendering the study exempt from IRB approval or informed consent restrictions according to European research requirements. The CE-certified foam dressing was used according to manufacturer recommendations, stated previously. Physicians recruited patients with wounds of varying depths if management with the foam dressing was indicated. A questionnaire was completed at the beginning of the study that included the patients’ age, sex, type and duration of the wound, prior treatment, physical condition, and concomitant medication. The attending physicians visually assessed the clinical appearance of the wound at the beginning of the study and after three dressing changes, estimating the proportion (%) of slough/eschar, granulation, and epithelial tissue in the wound bed. Also assessed were exudate level (rated using a four-point scale as none, sparse, moderate, heavy); periwound skin condition (no abnormal findings, edema, erythema, hyperthermia, maceration, eczema, hyperkeratosis, infection, and other); and wound pain (patient verbal rating scale: none, mild, moderate, strong). Wound size was determined using a tape measure and depth was estimated by the physicians.
Experience from previous observational studies9,10 have shown that the questionnaire was able to effectively evaluate the clinical performance of a wound dressing. Additionally, inter-observer variations were minimized by including definitions of the items recorded and involving a number of centers.
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