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

Wound Heal Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04960553
• Other study ID #: PD-708370
• Status: Terminated
• Phase: N/A
• Start date: December 7, 2021
• Est. completion date: January 20, 2023

Study information

• Verified date: February 2023
• Source: Molnlycke Health Care AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: January 20, 2023
• Est. primary completion date: January 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Wound Heal
• Wounds and Injuries

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Molnlycke Health Care AB

Countries where clinical trial is conducted

Belgium,  Portugal,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Dressing wear time	Dressing wear time of the Exufiber dressing and the Mepilex Border Flex dressing, and supporting techniques applied.	Up to12 weeks
Secondary	Cost-effectiveness	Cost-effectiveness; wound care consumables and frequency of dressings changes.	Up to12 weeks