A Prospective, Open-Label Study to Assess the Clinical Performance of a Foam Dressing in the Management of Chronic Wounds

Petra Zoellner, PhD; Holger Kapp, MS; and Hans Smola, MD

The results are consistent with other studies using this product for local wound care. Open, non-comparative trials using the foam dressing to manage patients with diabetic foot lesions11 or venous leg ulcers12 resulted in a considerable reduction in wound area, pain, and exudate levels. Additionally, randomized, controlled studies involving patients with chronic wounds confirm the good clinical performance and ease of application of foam dressings in the treatment of chronic wounds.13,14

Owing to their absorption and retention capacity, foam dressings have been shown to generally maintain a balance between moisture and exudate management that supports wound healing.8,15 Because this was a small non-randomized and non-comparative clinical observational trial, information about the clinical performance and tolerance of the treatment with the foam dressing is preliminary and does not provide proof of efficacy. However, the results offer real-world outcomes obtained in a panel of patients with nonhealing wounds commonly encountered in daily practice.

Most patients in this study suffered from chronic, nonhealing wounds with correspondingly poor wound bed and periwound skin condition. In most wounds studied, more than half the area was covered with slough and one in three wounds had heavy exudate. Results indicate that an excessive amount of exudate causes the degradation of extracellular matrix proteins and growth factors, prolongs inflammation, interferes with cell proliferation, and eventually leads to the breakdown of the vulnerable granulation tissue.16,17 Therefore, it has been suggested that absorbing excessive wound fluid, while still providing a moist environment, is important for the healing process of chronic wounds.18

The skin surrounding nonhealing ulcers is sensitive and prone to macerations, erythema, edema, and erosions due to excessive wound exudate.19 This is especially true in elderly people, whose skin is often sensitive due to age-related changes.20 Dressings should protect the surrounding skin from excessive exudate. The study results suggest that the dressing effectively handles exudate because the number of patients with surrounding skin maceration was lower at the final evaluation and the percentage of patients with normal perilesional skin increased from 49% to nearly 67% at the end of the study. While the concomitant use of supportive measures (eg, pressure relief and compression bandages) most likely improved the peristomal skin condition and, in the case of venous ulcers, helped reduce exudate levels, the improvements during an average of 9 days of care were encouraging. More than 80% of examining physicians judged the foam dressing’s exudate management as “very good” or “good”.

Several published reviews on pain associated with chronic wounds has a notable impact on quality of life.21,22 Dressing removal is considered to be the most painful procedure apart from sharp debridement for most patients.23 To prevent painful dressing changes, design and material of dressings have been optimized to be less traumatic — ie, clinicians should choose dressings that do not stick to the wound.23 In this study, the proportion of patients reporting wound pain decreased and ease of removal was rated “very good” by the majority of physicians. Furthermore, the findings suggest that wound fluid handling characteristics were well balanced. If not enough fluid had been absorbed, the proportion of wounds with periwound maceration would have increased; if too much fluid been absorbed, the dressing would have adhered to the wound bed, causing pain on removal.


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