Back to resultsInvestigation Evaluating Handling of Mepitel® One Used in Acute Wounds in Home Care
Primary Purpose
Acute Wounds
Status
Withdrawn
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Mepitel One
Sponsored by
About this trial
This is an interventional supportive care trial for Acute Wounds
Eligibility Criteria
Inclusion Criteria:
- Acute wounds/burns
- Male or female, 18 years and above, both in- and outpatients.
- Signed Informed Consent Form
Exclusion Criteria:
- Wound size above 21x24.5 cm
- Subject not expected to follow the investigation procedures
- Subjects previously included in this investigation
- Subjects included in other ongoing clinical investigation at present or during the past 30 days
Sites / Locations
- Chir-Praxis
Outcomes
Primary Outcome Measures
to evaluate the handling of Mepitel® One when used in acute wounds in home care.
Secondary Outcome Measures
to evaluate the comfort, conformability, stay-on ability, pain at removal, transparency of dressing and adverse events.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01164982
Brief Title
Investigation Evaluating Handling of Mepitel® One Used in Acute Wounds in Home 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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Withdrawn
Why Stopped
No resources available at the clinic
Study Start Date
March 2010 (undefined)
Primary Completion Date
August 2010 (Anticipated)
Study Completion Date
November 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Molnlycke Health Care AB
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Wounds
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Mepitel One
Intervention Description
Each subject will be followed once a week for 3 weeks or until healing if that occurs earlier
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Acute wounds/burns
Male or female, 18 years and above, both in- and outpatients.
Signed Informed Consent Form
Exclusion Criteria:
Wound size above 21x24.5 cm
Subject not expected to follow the investigation procedures
Subjects previously included in this investigation
Subjects included in other ongoing clinical investigation at present or during the past 30 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans J Höning, Dr
Organizational Affiliation
Chir-Praxis, Hamburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chir-Praxis
City
Hamburg
State/Province
Hamm
ZIP/Postal Code
59065
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Investigation Evaluating Handling of Mepitel® One Used in Acute Wounds in Home Care
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