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

Pressure Ulcers Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02224404
• Other study ID #: CHEXU02
• Status: Completed
• Phase: N/A
• First received: August 21, 2014
• Last updated: September 7, 2015
• Start date: September 2014
• Est. completion date: July 2015

Study information

• Verified date: August 2014
• Source: Molnlycke Health Care AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pressure Ulcer
• Pressure Ulcers
• Ulcer

Intervention

Device:
• Fast Gelling Dressing (Exufiber)

Locations

Country	Name	City	State
Belgium	Dep. of Plastic Surgery UZ Bruzzel	Brussel
Belgium	University Hospital Gent, Belgium	Gent
Belgium	Dermatologie Campus Kennedylaan	Kortrijk
Finland	Töölö Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Molnlycke Health Care AB

Countries where clinical trial is conducted

Belgium,  Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in peri-wound skin	the subjects will be measured by the following variables; maceration, redness/irritation, rash/eczema, blistering, dermatitis, skin stripping, trauma to wound edges and presence of residual from study product on the skin	6 weeks	No
Secondary	evaluate the level of pain in connection to dressing changes, changes in wound status, clinician's and subject's opinion, and technical performance	This will be measured by the following variables; visual analog scale, changes in wound size, volume and healing phase, questions about the clinician's/subject's opinion, dressing wear time, presence of residuals after removal and handling of exudates.	6 weeks	No