Investigation Evaluating Handling of Mepitel® One Used in Acute Wounds in Home Care

Study Overview
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Brief Summary
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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.

Detailed Description
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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:

Official Title
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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

Conditions
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Acute Wounds

Intervention / Treatment
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* Device: Mepitel One


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Mepitel One|Each subject will be followed once a week for 3 weeks or until healing if that occurs earlier|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the handling of Mepitel® One when used in acute wounds in home care. |  | once a week for 3 weeks or until healing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the comfort, conformability, stay-on ability, pain at removal, transparency of dressing and adverse events. |  | once a week for 3 weeks or until healing |