Post Market Clinical Follow-up Investigation to Evaluate Performance and Safety on Pressure Ulcers, PU, When Using Exufiber as Intended
Open, Non-comparative, Multi-centre Post Market Clinical Follow-up Investigation to Evaluate Performance and Safety on Pressure Ulcers, PU, When Using Exufiber as Intended
1 other identifier
interventional
21
2 countries
4
Brief Summary
The primary objective of this post market clinical follow-up (PMCF) investigation is to evaluate performance and safety of Exufiber when used as intended in Stage II-IV pressure ulcers (PU).
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 Sep 2014
Shorter than P25 for not_applicable
4 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
First Submitted
Initial submission to the registry
August 21, 2014
CompletedFirst Posted
Study publicly available on registry
August 25, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedResults Posted
Study results publicly available
October 19, 2016
CompletedMarch 27, 2017
August 1, 2014
10 months
August 21, 2014
May 18, 2016
February 23, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Worsening in Peri-Skin Wound.(Maceration From Baseline to 6 Weeks)
the subjects will be measured by the following variables; maceration,
6 weeks
Secondary Outcomes (1)
Evaluate the Level of Pain at Week 6 Changes in Wound Status, Clinician's and Subject's Opinion, and Technical Performance
6 weeks
Study Arms (1)
Fast Gelling Dressing
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Both gender ≥18 years old.
- Subjects with Stage 2, 3 or 4 cavity pressure ulcer (acc to EPUAP)
- Exuding pressure ulcer
- Signed Informed Consent.
You may not qualify if:
- Known allergy/hypersensitivity to the dressing.
- Infected wounds, (2 signs of infection/local inflammation and a positive swab)
- Stage 1 PU
- Dry wounds
- Subjects who will have problems following the protocol
- Subjects included in other ongoing clinical investigation at present or during the past 30 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Dermatologie Campus Kennedylaan
Kortrijk, Kortrijk, 8500, Belgium
Dep. of Plastic Surgery UZ Bruzzel
Brussels, 1000, Belgium
University Hospital Gent, Belgium
Ghent, 9000 Gent, Belgium
Töölö Hospital
Helsinki, 00260, Finland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Hilde Beele
- Organization
- Universitair Ziekenhuis Gent
Study Officials
- PRINCIPAL INVESTIGATOR
Hilde Beele, prof. dr
University Hospital Gent, Belgium
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
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
August 21, 2014
First Posted
August 25, 2014
Study Start
September 1, 2014
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
March 27, 2017
Results First Posted
October 19, 2016
Record last verified: 2014-08