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

Primary Purpose

Wound Heal

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Exufiber® and Mepilex® Border Flex
Sponsored by
Molnlycke Health Care AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Heal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Onze-Lieve-Vrouwziekenhuis
  • UZ Brussel
  • Unidade de Cuidados Continuados Ordem da Trindade
  • Unidade Cuidados Continuados - Mutivaze - WeCare
  • Northumbria Healthcare NHS Foundation Trust
  • Manchester University NHS Foundation Trust
  • Salford Royal NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Device : Post Market Clinical Follow-up Investigation applying Exufiber® and Mepilex® Border Flex

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
Dressing wear time
Dressing wear time of the Exufiber dressing and the Mepilex Border Flex dressing, and supporting techniques applied.
Cost-effectiveness
Cost-effectiveness; wound care consumables and frequency of dressings changes.

Full Information

First Posted
June 21, 2021
Last Updated
February 20, 2023
Sponsor
Molnlycke Health Care AB
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1. Study Identification

Unique Protocol Identification Number
NCT04960553
Brief Title
A PMCF Investigation on Exuding Chronic Wounds Using Exufiber® as Primary Dressing, and Mepilex® Border Flex/Comfort
Acronym
ExuFlex01
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
The study was early terminated because new data related to the investigational device were available making this investigation no longer scientifically relevant
Study Start Date
December 7, 2021 (Actual)
Primary Completion Date
January 20, 2023 (Actual)
Study Completion Date
January 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Molnlycke Health Care AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Heal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Device : Post Market Clinical Follow-up Investigation applying Exufiber® and Mepilex® Border Flex
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Exufiber® and Mepilex® Border Flex
Intervention Description
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
Primary Outcome Measure Information:
Title
Wound progress measured by investigator evaluation
Description
Wound progress of exuding chronic wounds from baseline to last visit where Exufiber is applicable, up to 12 weeks.
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Wound progress measured by investigator evaluation
Description
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.
Time Frame
Up to 12 weeks
Title
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
Description
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.
Time Frame
Up to 12 weeks
Title
Change in necrotic/sloughy tissue of exuding chronic wounds captured through visual judgement by investigator/designee through a scale in percentage
Description
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.
Time Frame
Up to 12 weeks
Title
Change in granulation tissue of exuding chronic wounds captured through visual judgement by investigator/designee through a scale in percentage
Description
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.
Time Frame
Up to12 weeks
Title
Changes in peri-wound skin condition of exuding chronic wounds
Description
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.
Time Frame
Up to12 weeks
Title
Device usability, wound fluid retention and dressing properties
Description
Investigator's evaluation of the wound status and the Exufiber and Mepilex Border Flex dressings, including usability, wound fluid retention and dressing properties.
Time Frame
Up to 12 weeks
Title
Subject's perception of pain and comfort
Description
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.
Time Frame
Up to12 weeks
Title
Dressing wear time
Description
Dressing wear time of the Exufiber dressing and the Mepilex Border Flex dressing, and supporting techniques applied.
Time Frame
Up to12 weeks
Title
Cost-effectiveness
Description
Cost-effectiveness; wound care consumables and frequency of dressings changes.
Time Frame
Up to12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Onze-Lieve-Vrouwziekenhuis
City
Aalst
Country
Belgium
Facility Name
UZ Brussel
City
Jette
Country
Belgium
Facility Name
Unidade de Cuidados Continuados Ordem da Trindade
City
Porto
Country
Portugal
Facility Name
Unidade Cuidados Continuados - Mutivaze - WeCare
City
Póvoa De Varzim
Country
Portugal
Facility Name
Northumbria Healthcare NHS Foundation Trust
City
Ashington
Country
United Kingdom
Facility Name
Manchester University NHS Foundation Trust
City
Manchester
Country
United Kingdom
Facility Name
Salford Royal NHS Foundation Trust
City
Salford
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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