Acute Wounds Clinical Trial
Official title:
An Open Non-controlled Proof of Concept Investigation Evaluating the Handling of a Soft Silicone Wound Contact Layer, Mepitel® One Used in Acute Wounds in Home Care
The primary objective is to evaluate the handling of Mepitel® One when used in acute wounds
in home care.
Secondary objective is to evaluate the comfort, conformability, stay-on ability, pain at
removal, transparency of dressing and adverse events.
The investigation is designed as an open, non-controlled, proof of concept investigation.
Subjects with acute wounds at one centre will be included. Each subject will be followed
once a week for 3 weeks or until healing if that occurs earlier. All dressing changes will
be done according to clinical routine and registered in a dressing log. Cover dressing will
be used when needed according to clinical routine.
A total of 10 subjects will be enrolled provided that they fulfil all the inclusion criteria
and none of the exclusion criteria and have signed and dated the written informed consent.
The subjects will be consecutively allocated to a subject code.
At baseline, subject characteristics will be registered together with subject status of
health, wound history and wound status, wound characteristics and current treatment of the
wound.
The following variables will be measured as follows:
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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