Back to resultsPost Market Clinical Follow-up Investigation to Evaluate Performance and Safety on Pressure Ulcers, PU, When Using Exufiber as Intended
Primary Purpose
Pressure Ulcers
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Fast Gelling Dressing (Exufiber)
Sponsored by
About this trial
This is an interventional treatment trial for Pressure Ulcers
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
Sites / Locations
- Dep. of Plastic Surgery UZ Bruzzel
- University Hospital Gent, Belgium
- Dermatologie Campus Kennedylaan
- Töölö Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fast Gelling Dressing
Arm Description
Outcomes
Primary Outcome Measures
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,
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02224404
First Posted
August 21, 2014
Last Updated
February 23, 2017
Sponsor
Molnlycke Health Care AB
1. Study Identification
Unique Protocol Identification Number
NCT02224404
Brief Title
Post Market Clinical Follow-up Investigation to Evaluate Performance and Safety on Pressure Ulcers, PU, When Using Exufiber as Intended
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Molnlycke Health Care AB
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fast Gelling Dressing
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Fast Gelling Dressing (Exufiber)
Primary Outcome Measure Information:
Title
Number of Participants With Worsening in Peri-Skin Wound.(Maceration From Baseline to 6 Weeks)
Description
the subjects will be measured by the following variables; maceration,
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Evaluate the Level of Pain at Week 6 Changes in Wound Status, Clinician's and Subject's Opinion, and Technical Performance
Description
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
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hilde Beele, prof. dr
Organizational Affiliation
University Hospital Gent, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dep. of Plastic Surgery UZ Bruzzel
City
Brussel
ZIP/Postal Code
1000
Country
Belgium
Facility Name
University Hospital Gent, Belgium
City
Gent
ZIP/Postal Code
9000 Gent
Country
Belgium
Facility Name
Dermatologie Campus Kennedylaan
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
Töölö Hospital
City
Helsinki
ZIP/Postal Code
00260
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Post Market Clinical Follow-up Investigation to Evaluate Performance and Safety on Pressure Ulcers, PU, When Using Exufiber as Intended
We'll reach out to this number within 24 hrs