Post Market Clinical Follow-up Investigation to Evaluate Performance and Safety on Pressure Ulcers, PU, When Using Exufiber as Intended

Not Applicable

Completed

• Conditions: Pressure Ulcers
• Interventions: Device: Fast Gelling Dressing (Exufiber)

• Registration Number: NCT02224404
• Lead Sponsor: Molnlycke Health Care AB

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-08
• Study First Submitted: 2014-08-21
• Study First Submitted QC: 2014-08-22
• Study First Posted: 2014-08-25
• Study Start: 2014-09
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Results First Submitted: 2016-05-18
• Results First Submitted QC: 2016-08-25
• Results First Posted: 2016-10-19
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fast Gelling Dressing	Fast Gelling Dressing (Exufiber)	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Worsening in Peri-Skin Wound.(Maceration From Baseline to 6 Weeks)	6 weeks	the subjects will be measured by the following variables; maceration,

Secondary Outcome Measures

Name	Time	Method
Evaluate the Level of Pain at Week 6 Changes in Wound Status, Clinician's and Subject's Opinion, and Technical Performance	6 weeks	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

Trial Locations

Locations (4)

Dep. of Plastic Surgery UZ Bruzzel; 🇧🇪 Brussel, Belgium

University Hospital Gent, Belgium; 🇧🇪 Gent, Belgium

Töölö Hospital; 🇫🇮 Helsinki, Finland

Dermatologie Campus Kennedylaan; 🇧🇪 Kortrijk, Belgium