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

NCT04960553 | Terminated

• 1 other identifier: PD-708370
• Study Type: interventional
• Target: 34
• Locations: 3 countries
• Sites: 7

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.

Conditions

Wound Heal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Wound progress measured by investigator evaluation

  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

  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

  Up to 12 weeks

• Change in granulation tissue of exuding chronic wounds captured through visual judgement by investigator/designee through a scale in percentage

  Up to12 weeks

• Changes in peri-wound skin condition of exuding chronic wounds

  Up to12 weeks

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

Exufiber® and Mepilex® Border Flex DEVICE

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Molnlycke Health Care AB: lead

Study Sites (7)

Onze-Lieve-Vrouwziekenhuis

Aalst, Belgium

Location

UZ Brussel

Jette, Belgium

Location

Unidade de Cuidados Continuados Ordem da Trindade

Porto, Portugal

Location

Unidade Cuidados Continuados - Mutivaze - WeCare

Póvoa de Varzim, Portugal

Location

Northumbria Healthcare NHS Foundation Trust

Ashington, United Kingdom

Location

Manchester University NHS Foundation Trust

Manchester, United Kingdom

Location

Salford Royal NHS Foundation Trust

Salford, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: July 14, 2021
• Study Start: December 7, 2021
• Primary Completion: January 20, 2023
• Study Completion: January 20, 2023
• Last Updated: February 22, 2023

Record last verified: 2023-02

Locations

GB (3); PT (2); BE (2)