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

Molnlycke Health Care AB34 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Wound Heal

Interventions

Exufiber® and Mepilex® Border FlexDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (7)

Onze-Lieve-Vrouwziekenhuis

Aalst, Belgium

UZ Brussel

Jette, Belgium

Unidade de Cuidados Continuados Ordem da Trindade

Porto, Portugal

Unidade Cuidados Continuados - Mutivaze - WeCare

Póvoa de Varzim, Portugal

Outcomes

Primary Outcomes

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.

Time frame: Up to 12 weeks

Secondary Outcomes

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.

Time frame: Up to 12 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to12 weeks

Data from ClinicalTrials.gov

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