Pressure UlcersNCT02224404
Post Market Clinical Follow-up Investigation to Evaluate Performance and Safety on Pressure Ulcers, PU, When Using Exufiber as Intended
A study testing Fast Gelling Dressing (Exufiber) in people with Pressure Ulcers, run by Molnlycke Health Care AB at 4 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcers
- What is being tested?
- Fast Gelling Dressing (Exufiber)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Sep 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both gender ≥18 years old.
- Subjects with Stage 2, 3 or 4 cavity pressure ulcer (acc to EPUAP)
- Exuding pressure ulcer
- Signed Informed Consent.
Who cannot join
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Belgium3 sites
Dep. of Plastic Surgery UZ Bruzzel
Brussels, 1000
University Hospital Gent, Belgium
Ghent, 9000 Gent
Dermatologie Campus Kennedylaan
Kortrijk, Kortrijk, 8500
About this study
Official title: 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
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).
- Conditions
- Pressure Ulcers
- Being tested
- Fast Gelling Dressing (Exufiber)
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast Gelling Dressing (Exufiber)Device
| Study group | Role | What they receive |
|---|---|---|
| Fast Gelling Dressing | Experimental | Not described Receives: Device: Fast Gelling Dressing (Exufiber) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Measured: 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
Pain during product removal at week 6, measured by Visual Analog scale.This will be measured by the following variables; visual analog scale, 0=no pain, 100= worst pain, scale from 0-100 mm
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pressure UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hilde Beele, prof. dr, Principal investigator, University Hospital Gent, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02224404
- Sponsor's protocol ID
- CHEXU02
- Status last verified
- Aug 2014
- First submitted
- 21 Aug 2014
- Last updated
- 27 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02224404
- Acronym / sponsor ID
- CHEXU02
- Conditions
- Pressure Ulcers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 25 Aug 2014 (estimated)
- Results
- Posted 19 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fast Gelling Dressing | Experimental | Device: Fast Gelling Dressing (Exufiber) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Both gender ≥18 years old.
- Subjects with Stage 2, 3 or 4 cavity pressure ulcer (acc to EPUAP)
- Exuding pressure ulcer
- Signed Informed Consent.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fast Gelling Dressing (Exufiber) | Device | Fast Gelling Dressing |
Primary outcome
Number of Participants With Worsening in Peri-Skin Wound.(Maceration From Baseline to 6 Weeks)
Time frame: 6 weeks
the subjects will be measured by the following variables; maceration,
1 secondary outcome
Evaluate the Level of Pain at Week 6 Changes in Wound Status, Clinician's and Subject's Opinion, and Technical Performance
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilde Beele, prof. dr principal investigator
University Hospital Gent, Belgium
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fast Gelling Dressing (Exufiber) in people with Pressure Ulcers, run by Molnlycke Health Care AB at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Worsening in Peri-Skin Wound.(Maceration From Baseline to 6 Weeks) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017.