Investigation Evaluating Handling of Mepitel® One Used in Acute Wounds in Home Care
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Details and patient eligibility
About
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.
Full description
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:
Sex
Ages
Volunteers
Inclusion criteria
- Acute wounds/burns
- Male or female, 18 years and above, both in- and outpatients.
- Signed Informed Consent Form
Exclusion criteria
- Wound size above 21x24.5 cm
- Subject not expected to follow the investigation procedures
- Subjects previously included in this investigation
- Subjects included in other ongoing clinical investigation at present or during the past 30 days
Trial design
Primary purpose
Allocation
Interventional model
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Data sourced from clinicaltrials.gov
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