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Open-Label Test of the HM242 Medical Devices to Evaluate Safety and Local Tolerability

B. Braun Ltd. Centre of Excellence Infection Control · 2020
ClinicalTrials.gov · Datasets · License: Public Domain · 2020
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It is the first clinical study aimed at assessing the safety and tolerability of HM242-Solution and HM242-Gel after their application under occlusion on intact skin. The HM242-Solution is intended for chronic wounds (e.g. pressure, venous leg and diabetic foot ulcers). The HM242-Solution should be used for physical rinsing and cleansing and subsequent decolonization of the wound prior to treatment with hydrogels and dressings. The HM242-Gel is a hydrogel for wound bed preparation to support the healing of the skin due to cleansing, moistening and subsequent decolonization and the coating of the wound. The study will be conducted in outpatient manner, adult patients who are healthy and has an intact skin. This is an prospective, open label, monocentric study. No comparative control group is planned as no other preventing infection solution is commercially available at this time.
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