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OpenTrials
Completed

NCT Number: NCT02224404

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).

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Key information

Conditions

Pressure Ulcers Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dermatologie Campus Kennedylaan, Kortrijk, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fast Gelling Dressing (Exufiber)

Device

Primary outcomes

  1. 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,

Secondary outcomes

  1. 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

    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

Sponsors and collaborators

Lead sponsor

Molnlycke Health Care AB

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 25, 2014
Registry last updated
Mar 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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