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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Pressure Ulcers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fast Gelling Dressing

Group Type EXPERIMENTAL

Fast Gelling Dressing (Exufiber)

Intervention Type DEVICE

Interventions

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Fast Gelling Dressing (Exufiber)

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No