A PMCF Investigation on Exuding Chronic Wounds Using Exufiber® as Primary Dressing, and Mepilex® Border Flex/Comfort (ExuFlex01)

Prospective, Open, Non-comparative, Multi-centre, Post Market Clinical Follow-up Investigation to Follow the Progress of Exuding Chronic Wounds to Healing Using Exufiber® as Primary Dressing, and Mepilex® Border Flex/Comfort

The overall objective of this post market clinical follow-up (PMCF) investigation is to follow the progress of exuding chronic wounds to healing, or up to 12 weeks, whichever occurs first, consecutively using Exufiber® as primary dressing, and Mepilex® Border Flex (Mepilex Border Comfort) as primary dressing.

Study Overview

• Status: Terminated
• Conditions: Wound Heal
• Intervention / Treatment: Device: Exufiber® and Mepilex® Border Flex

Detailed Description

This investigation is as a prospective, open, non-comparative, multi-centre investigation with the aim to follow exuding chronic wound progression. The investigation will include subjects from three populations suffering from exuding chronic wounds (Venous Leg Ulcers, Diabetic Foot Ulcers and Pressure Ulcers). The target wound for all subjects will initially be treated with Exufiber® as primary dressing. As the wound progress and wound exudate production is reduced, the Exufiber will be replaced by the Mepilex Border Flex dressing. For ulcers located at sacrum or heel, the Mepilex Border Heel or Mepilex Border Sacrum will be used.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium
    • Onze-Lieve-Vrouwziekenhuis
  • Jette, Belgium
    • UZ Brussel
• Portugal
  • Porto, Portugal
    • Unidade de Cuidados Continuados Ordem da Trindade
  • Póvoa De Varzim, Portugal
    • Unidade Cuidados Continuados - Mutivaze - WeCare
• United Kingdom
  • Ashington, United Kingdom
    • Northumbria Healthcare NHS Foundation Trust
  • Manchester, United Kingdom
    • Manchester University NHS Foundation Trust
  • Salford, United Kingdom
    • Salford Royal NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Provision of informed consent
• Both genders ≥18 years old.
• Exuding pressure ulcer, exuding diabetic foot ulcer or exuding venous leg ulcer (an exuding wound defined as one that requires highly absorbent dressing - as per clinical judgement)
• Chronic wound at least 4 weeks duration (chronic would be defined after 4 weeks).
• ABPI (within the last 3 months) ≥0.7 for both legs (if both present). If ABPI >1.4, then big toe pressure >60mmHg is required or an alternative measurement verifying normal distal arterial flow.
• At entry into the study, the ulcer or wound area should be 0.8 cm² - 70 cm².

Exclusion Criteria:

• Known allergy/hypersensitivity to the dressing or its components.
• Subject included in other ongoing clinical investigation at present or during the past 30 days
• Pregnancy or lactation at time of study participation.
• Target wound DFU <0.8 cm² , VLU <3 cm² , PU <1 cm² , post debridement (measured as greatest length x greatest width)
• Infected ulcer according to the judgment of the investigator defined as any wound condition requiring the prescription or continuation of systemic antibiotic therapy at recruitment.
• Other wounds within 3 cm from target wound
• Subject not suitable for the investigation according to the investigator's judgement.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device : Post Market Clinical Follow-up Investigation applying Exufiber® and Mepilex® Border Flex; Post Market Clinical Follow-up investigation : Up to 102 subjects with exuding chronic wounds deemed adequate by the Principle Investigator and Clinical Team for assigned treatment	Device: Exufiber® and Mepilex® Border Flex; Post Market Clinical Follow-up Investigation applying Exufiber® and Mepilex® Border Flex to 102 subjects who meet the study criteria for up to 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound progress measured by investigator evaluation	Wound progress of exuding chronic wounds from baseline to last visit where Exufiber is applicable, up to 12 weeks.	Up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound progress measured by investigator evaluation	Wound progress of exuding chronic wounds from baseline to final visit and from first visit where Mepilex Border Flex is applicable as primary dressing to final visit.	Up to 12 weeks
Changes in peri-wound skin condition of exuding chronic wounds	Changes in peri-wound skin condition of exuding chronic wounds from baseline to last visit where Exufiber is applicable and to final visit; and from first visit where Mepilex Border Flex is applicable as primary dressing to final visit.	Up to12 weeks
Device usability, wound fluid retention and dressing properties	Investigator's evaluation of the wound status and the Exufiber and Mepilex Border Flex dressings, including usability, wound fluid retention and dressing properties.	Up to 12 weeks
Dressing wear time	Dressing wear time of the Exufiber dressing and the Mepilex Border Flex dressing, and supporting techniques applied.	Up to12 weeks
Cost-effectiveness	Cost-effectiveness; wound care consumables and frequency of dressings changes.	Up to12 weeks
Absolute and percentage change in wound area of exuding chronic wounds captured by an independent evaluator evaluating wound photos through the software program PictZar® Digital Planimetry	Absolute and percentage change in wound area of exuding chronic wounds, from baseline to last visit where Exufiber is applicable and to final visit; and from first visit where Mepilex Border Flex is applicable as primary dressing to final visit.	Up to 12 weeks
Change in necrotic/sloughy tissue of exuding chronic wounds captured through visual judgement by investigator/designee through a scale in percentage	Change in necrotic/sloughy tissue of exuding chronic wounds from baseline to last visit where Exufiber is applicable and to final visit; and from first visit where Mepilex Border Flex is applicable as primary dressing to final visit.	Up to 12 weeks
Change in granulation tissue of exuding chronic wounds captured through visual judgement by investigator/designee through a scale in percentage	Assessment of exuding wound from baseline to last visit where Exufiber is applicable and to final visit; and from first visit where Mepilex Border Flex is applicable as primary dressing to final visit.	Up to12 weeks
Subject's perception of pain and comfort	Subject's perception of Pain and Pain intensity with a numerical rating scale (NRS) range 0-10 cm where 0 is no pain and 10 pain as intense you can imagine. Comfort during Exufiber and Mepilex Border Flex dressings application, removal and use evaluated through questions asked by the investigator/designee to the subject with a range from very poor to very good.	Up to12 weeks

Collaborators and Investigators

• Sponsor: Molnlycke Health Care AB

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2021
• Primary Completion (Actual): January 20, 2023
• Study Completion (Actual): January 20, 2023

Study Registration Dates

• First Submitted: June 21, 2021
• First Submitted That Met QC Criteria: July 9, 2021
• First Posted (Actual): July 14, 2021

Study Record Updates

• Last Update Posted (Estimate): February 22, 2023
• Last Update Submitted That Met QC Criteria: February 20, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: PD-708370

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No