Back to resultsA Prospective, Open, Non-controlled Clinical Investigation to Evaluate the Performance and Safety of an Antimicrobial Foam Transferring Dressing in Patients With Malignant Wounds
Primary Purpose
Malignant Wounds
Status
Completed
Phase
Not Applicable
Locations
Czech Republic
Study Type
Interventional
Intervention
Mepilex Transfer Ag
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Wounds focused on measuring Presence of at least one exuding malignant (fungating) wound in need for antimicrobial treatment
Eligibility Criteria
Inclusion Criteria:
- Presence of at least one exuding malignant (fungating) wound in need for antimicrobial treatment
- Both genders with an age ≥ 18 years at randomization
- Subjects with a suspected survival time of > 3 months
- Signed informed consent
Exclusion Criteria:
- Any known or suspected systemic infection
- Use of metronidazole is not allowed during the investigation period
- Any known sensitivity to silver or other components/products used in this study.
- Major uncontrolled systemic disorders such as hepatic, renal, neurologic, or endocrinologic disorders.
- Participation in another investigational study while participating in this study.
Sites / Locations
- Charles University School of Medicine
- The General University Hospital in Prague
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mepilex Transfer Ag
Arm Description
Non controlled investigation
Outcomes
Primary Outcome Measures
Infection in the Wound (Signs of Clinical Infection)
Weekly Visual inspection of the wounds by the investigators.
Secondary Outcome Measures
Full Information
NCT ID
NCT02431741
First Posted
April 28, 2015
Last Updated
April 18, 2017
Sponsor
Molnlycke Health Care AB
1. Study Identification
Unique Protocol Identification Number
NCT02431741
Brief Title
A Prospective, Open, Non-controlled Clinical Investigation to Evaluate the Performance and Safety of an Antimicrobial Foam Transferring Dressing in Patients With Malignant Wounds
Official Title
Title: A Prospective, Open, Non-controlled Clinical Investigation to Evaluate the Performance and Safety of an Antimicrobial Foam Transferring Dressing in Patients With Malignant Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Molnlycke Health Care AB
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective, open, non-controlled clinical investigation to evaluate the performance and safety of using Mepilex Transfer Ag on a malignant wound. Approximately ten to fifteen (10-15) subjects from one to three centers in Europe, presenting with a malignant (fungating) wound will be enrolled into the study. Eligible subjects will have one malignant (fungating) wound selected as a "study site". Subjects will be followed for a one-week observation period with their existing product followed by a 4-week investigation period using Mepilex Transfer Ag.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Wounds
Keywords
Presence of at least one exuding malignant (fungating) wound in need for antimicrobial treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mepilex Transfer Ag
Arm Type
Experimental
Arm Description
Non controlled investigation
Intervention Type
Device
Intervention Name(s)
Mepilex Transfer Ag
Primary Outcome Measure Information:
Title
Infection in the Wound (Signs of Clinical Infection)
Description
Weekly Visual inspection of the wounds by the investigators.
Time Frame
weekly, for 5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Presence of at least one exuding malignant (fungating) wound in need for antimicrobial treatment
Both genders with an age ≥ 18 years at randomization
Subjects with a suspected survival time of > 3 months
Signed informed consent
Exclusion Criteria:
Any known or suspected systemic infection
Use of metronidazole is not allowed during the investigation period
Any known sensitivity to silver or other components/products used in this study.
Major uncontrolled systemic disorders such as hepatic, renal, neurologic, or endocrinologic disorders.
Participation in another investigational study while participating in this study.
Facility Information:
Facility Name
Charles University School of Medicine
City
Prague
Country
Czech Republic
Facility Name
The General University Hospital in Prague
City
Prague
Country
Czech Republic
12. IPD Sharing Statement
Learn more about this trial
A Prospective, Open, Non-controlled Clinical Investigation to Evaluate the Performance and Safety of an Antimicrobial Foam Transferring Dressing in Patients With Malignant Wounds
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