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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-11-30

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.

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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:

Conditions

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Acute Wounds

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Interventions

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Mepitel One

Each subject will be followed once a week for 3 weeks or until healing if that occurs earlier

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Acute wounds/burns
2. Male or female, 18 years and above, both in- and outpatients.
3. Signed Informed Consent Form

Exclusion Criteria

1. Wound size above 21x24.5 cm
2. Subject not expected to follow the investigation procedures
3. Subjects previously included in this investigation
4. Subjects included in other ongoing clinical investigation at present or during the past 30 days

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No