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

Molnlycke Health Care

Status: Terminated

Conditions: Wound Heal

Treatments: Device: Exufiber® and Mepilex® Border Flex

Study type: Interventional

Funder types: Industry

Identifiers

NCT04960553

PD-708370

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

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

Experimental group

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

Treatment:

Device: Exufiber® and Mepilex® Border Flex