N/A
N=21
Post Market Clinical Follow-up Investigation to Evaluate Performance and Safety on Pressure Ulcers, PU, When Using Exufiber as Intended
Pressure Ulcers
Bottom Line
View on ClinicalTrials.gov: NCT02224404 ↗Enrolled (actual)
21
Serious AEs
4.8%
Results posted
Oct 2016
Primary outcome: Primary: Number of Participants With Worsening in Peri-Skin Wound.(Maceration From Baseline to 6 Weeks) — 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fast Gelling Dressing (Exufiber) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Molnlycke Health Care AB
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Worsening in Peri-Skin Wound.(Maceration From Baseline to 6 Weeks) |
2 | — |
| SECONDARY Evaluate the Level of Pain at Week 6 Changes in Wound Status, Clinician's and Subject's Opinion, and Technical Performance |
— | — |
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 Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02224404). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.