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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This study has been withdrawn prior to enrollment.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:
Information provided by:
Molnlycke Health Care AB
ClinicalTrials.gov Identifier:
NCT01164982
First received: July 16, 2010
Last updated: December 14, 2010
Last verified: December 2010
History of Changes

July 16, 2010
December 14, 2010
March 2010
August 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01164982 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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:
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Acute Wounds
Device: Mepitel One
Each subject will be followed once a week for 3 weeks or until healing if that occurs earlier
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
10
November 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01164982
MPTO 02
No
Jenny Thorell, Molnlycke Health Care AB
Molnlycke Health Care AB
Not Provided
Principal Investigator: Hans J Höning, Dr Chir-Praxis, Hamburg
Molnlycke Health Care AB
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP