Status:
COMPLETED
Post Market Clinical Follow-up Investigation to Evaluate Performance and Safety on Pressure Ulcers, PU, When Using Exufiber as Intended
Lead Sponsor:
Molnlycke Health Care AB
Conditions:
Pressure Ulcers
Eligibility:
All Genders
18+ years
Phase:
NA
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).
Eligibility Criteria
Inclusion
- Both gender ≥18 years old.
- Subjects with Stage 2, 3 or 4 cavity pressure ulcer (acc to EPUAP)
- Exuding pressure ulcer
- Signed Informed Consent.
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT02224404
Start Date
September 1 2014
End Date
July 1 2015
Last Update
March 27 2017
Active Locations (4)
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1
Dermatologie Campus Kennedylaan
Kortrijk, Kortrijk, Belgium, 8500
2
Dep. of Plastic Surgery UZ Bruzzel
Brussels, Belgium, 1000
3
University Hospital Gent, Belgium
Ghent, Belgium, 9000 Gent
4
Töölö Hospital
Helsinki, Finland, 00260