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

This study has been withdrawn prior to enrollment.
(No resources available at the clinic)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01164982
First Posted: July 19, 2010
Last Update Posted: April 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Molnlycke Health Care AB
  Purpose

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.


Condition Intervention
Acute Wounds Device: Mepitel One

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Molnlycke Health Care AB:

Primary Outcome Measures:
  • to evaluate the handling of Mepitel® One when used in acute wounds in home care. [ Time Frame: once a week for 3 weeks or until healing ]

Secondary Outcome Measures:
  • to evaluate the comfort, conformability, stay-on ability, pain at removal, transparency of dressing and adverse events. [ Time Frame: once a week for 3 weeks or until healing ]

Enrollment: 0
Study Start Date: March 2010
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Mepitel One
    Each subject will be followed once a week for 3 weeks or until healing if that occurs earlier
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:

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01164982


Locations
Germany
Chir-Praxis
Hamburg, Hamm, Germany, 59065
Sponsors and Collaborators
Molnlycke Health Care AB
Investigators
Principal Investigator: Hans J Höning, Dr Chir-Praxis, Hamburg
  More Information

Responsible Party: Jenny Thorell, Molnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT01164982     History of Changes
Other Study ID Numbers: MPTO 02
First Submitted: July 16, 2010
First Posted: July 19, 2010
Last Update Posted: April 28, 2015
Last Verified: December 2010

Additional relevant MeSH terms:
Wounds and Injuries