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Clinical Trials/NCT02224404
NCT02224404
Completed
Not Applicable

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

Molnlycke Health Care AB4 sites in 2 countries21 target enrollmentSeptember 2014
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ConditionsPressure Ulcers

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pressure Ulcers
Sponsor
Molnlycke Health Care AB
Enrollment
21
Locations
4
Primary Endpoint
Number of Participants With Worsening in Peri-Skin Wound.(Maceration From Baseline to 6 Weeks)
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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).

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
July 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Molnlycke Health Care AB
Responsible Party
Sponsor

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)
  • •Subjects who will have problems following the protocol
  • •Subjects included in other ongoing clinical investigation at present or during the past 30 days

Outcomes

Primary Outcomes

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

  • Evaluate the Level of Pain at Week 6 Changes in Wound Status, Clinician's and Subject's Opinion, and Technical Performance(6 weeks)

Study Sites (4)

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