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Objective: Currently there is limited real-world research on the adhesion qualities, pain and clinical performance of specific silicone adhesives products, and their role in maintaining skin integrity and preventing medical adhesive-related skin injuries (MARSI). This paper presents a clinical evaluation of performance and safety parameters of two silicone adhesive dressings on lacerations or surgical wounds and the surrounding skin in daily practice on fragile skin.
Method: An observational, prospective, multicentre, uncontrolled post-market clinical observational study with Leukomed T skin sensitive and Leukomed T plus skin sensitive (both BSN medical GmbH, Essity Group) was undertaken at three sites across Germany between June 2021 to November 2022. Inclusion parameters were acute wounds (surgical or laceration) in patients with at least one fragile skin condition. Endpoints included: the percentage of adhered dressing area seven days after application of the dressings; and evaluation of any signs of skin damage and erythema following dressing removal. Furthermore, self-reported patient pain, comfort during dressing wear, and the health professionals' ease of dressing handling with gloves were assessed.
Results: A total of 42 patients with fragile skin and surgical wounds (35 patients) or lacerations (7 patients) were recruited. Mean age was 78 years. There were no signs of erythema following dressing removal and no MARSI (skin stripping, blister, skin tears, maceration, irritant contact dermatitis or allergic dermatitis) occurred at removal after seven days of wear time. Data demonstrated a reliable wound coverage with sufficient adhesion without negatively affecting the periwound skin and wound improvement was observed in 94% of patients. The vast majority of patients reported minimal pain at removal, reduced wound pain and high satisfaction with wearing comfort. Health professionals found the dressings easy to apply and remove, even with gloved hands.
Conclusion: The results of this real-world evidence showed effective and well-tolerated use of transparent dressings with silicone adhesive in patients with fragile skin. The dressings may reduce the risk of skin damage including MARSI, while providing patients a high wearing comfort and allowing an almost pain-free dressing change.
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| http://dx.doi.org/10.12968/jowc.2024.0308 | DOI Listing |
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