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

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01164982

Enrollment

Registered

2010-07-19

Start date

2010-03-31

Completion date

2010-11-30

Last updated

2015-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Wounds

Brief summary

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

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:

Interventions

DEVICEMepitel One

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026