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

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.

Study Overview

• Status: Withdrawn
• Conditions: Acute Wounds
• Intervention / Treatment: Device: Mepitel One

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:

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamm
    • Hamburg, Hamm, Germany, 59065
      • Chir-Praxis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Molnlycke Health Care AB
• Investigators: Principal Investigator: Hans J Höning, Dr, Chir-Praxis, Hamburg

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Anticipated): August 1, 2010
• Study Completion (Anticipated): November 1, 2010

Study Registration Dates

• First Submitted: July 16, 2010
• First Submitted That Met QC Criteria: July 16, 2010
• First Posted (Estimate): July 19, 2010

Study Record Updates

• Last Update Posted (Estimate): April 28, 2015
• Last Update Submitted That Met QC Criteria: April 27, 2015
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: MPTO 02