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

Not Applicable

Terminated

• Conditions: Wound Heal
• Interventions: Device: Exufiber® and Mepilex® Border Flex

• Registration Number: NCT04960553
• Lead Sponsor: Molnlycke Health Care AB

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.

Study Timeline

• Study First Submitted: 2021-06-21
• Study First Submitted QC: 2021-07-09
• Study First Posted: 2021-07-14
• Study Start: 2021-12-07
• Primary Completion: 2023-01-20
• Study Completion: 2023-01-20
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-20
• Last Update Posted: 2023-02-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in granulation tissue of exuding chronic wounds captured through visual judgement by investigator/designee through a scale in percentage	Up to12 weeks	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.
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	Up to 12 weeks	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.
Device usability, wound fluid retention and dressing properties	Up to 12 weeks	Investigator's evaluation of the wound status and the Exufiber and Mepilex Border Flex dressings, including usability, wound fluid retention and dressing properties.
Wound progress measured by investigator evaluation	Up to 12 weeks	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.
Change in necrotic/sloughy tissue of exuding chronic wounds captured through visual judgement by investigator/designee through a scale in percentage	Up to 12 weeks	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.
Subject's perception of pain and comfort	Up to12 weeks	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.
Cost-effectiveness	Up to12 weeks	Cost-effectiveness; wound care consumables and frequency of dressings changes.
Changes in peri-wound skin condition of exuding chronic wounds	Up to12 weeks	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.
Dressing wear time	Up to12 weeks	Dressing wear time of the Exufiber dressing and the Mepilex Border Flex dressing, and supporting techniques applied.

Trial Locations

Locations (7)

Unidade de Cuidados Continuados Ordem da Trindade; 🇵🇹 Porto, Portugal

UZ Brussel; 🇧🇪 Jette, Belgium

Unidade Cuidados Continuados - Mutivaze - WeCare; 🇵🇹 Póvoa De Varzim, Portugal

Manchester University NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom

Salford Royal NHS Foundation Trust; 🇬🇧 Salford, United Kingdom

Onze-Lieve-Vrouwziekenhuis; 🇧🇪 Aalst, Belgium

Northumbria Healthcare NHS Foundation Trust; 🇬🇧 Ashington, United Kingdom