A Prospective, Open, Non-controlled Clinical Investigation to Evaluate the Performance and Safety of an Antimicrobial Foam Transferring Dressing in Patients With Malignant Wounds
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
1 other identifier
interventional
14
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 28, 2015
CompletedFirst Posted
Study publicly available on registry
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedResults Posted
Study results publicly available
April 4, 2016
CompletedApril 25, 2017
April 1, 2015
10 months
April 28, 2015
March 4, 2016
April 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Infection in the Wound (Signs of Clinical Infection)
Weekly Visual inspection of the wounds by the investigators.
weekly, for 5 weeks
Study Arms (1)
Mepilex Transfer Ag
EXPERIMENTALNon controlled investigation
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Charles University School of Medicine
Prague, Prague, Czechia
The General University Hospital in Prague
Prague, Prague, Czechia
Results Point of Contact
- Title
- Prof. Dr. Petr Arenberger
- Organization
- Faculty Hospital Kralovske Czech Republic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2015
First Posted
May 1, 2015
Study Start
October 1, 2014
Primary Completion
August 1, 2015
Study Completion
December 1, 2015
Last Updated
April 25, 2017
Results First Posted
April 4, 2016
Record last verified: 2015-04