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

Molnlycke Health Care

Status: Completed

Conditions: Pressure Ulcers

Treatments: Device: Fast Gelling Dressing (Exufiber)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02224404

CHEXU02

Details and patient eligibility

About

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).

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Fast Gelling Dressing

Experimental group

Treatment:

Device: Fast Gelling Dressing (Exufiber)