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

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 Overview

• Status: Completed
• Conditions: Pressure Ulcers
• Intervention / Treatment: Device: Fast Gelling Dressing (Exufiber)

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussel, Belgium, 1000
    • Dep. of Plastic Surgery UZ Bruzzel
  • Gent, Belgium, 9000 Gent
    • University Hospital Gent, Belgium
  • Kortrijk, Belgium, 8500
    • Dermatologie Campus Kennedylaan
• Finland
  • Helsinki, Finland, 00260
    • Töölö Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Both gender ≥18 years old.
2. Subjects with Stage 2, 3 or 4 cavity pressure ulcer (acc to EPUAP)
3. Exuding pressure ulcer
4. Signed Informed Consent.

Exclusion Criteria:

1. Known allergy/hypersensitivity to the dressing.
2. Infected wounds, (2 signs of infection/local inflammation and a positive swab)
3. Stage 1 PU
4. Dry wounds
5. Subjects who will have problems following the protocol
6. Subjects included in other ongoing clinical investigation at present or during the past 30 days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fast Gelling Dressing	Device: Fast Gelling Dressing (Exufiber)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 weeks

Collaborators and Investigators

• Sponsor: Molnlycke Health Care AB
• Investigators: Principal Investigator: Hilde Beele, prof. dr, University Hospital Gent, Belgium

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: August 21, 2014
• First Submitted That Met QC Criteria: August 22, 2014
• First Posted (Estimate): August 25, 2014

Study Record Updates

• Last Update Posted (Actual): March 27, 2017
• Last Update Submitted That Met QC Criteria: February 23, 2017
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Pressure Ulcer
• Other Study ID Numbers: CHEXU02