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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-07

Study Completion Date

2023-01-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Wound Heal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Device : Post Market Clinical Follow-up Investigation applying 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

Group Type EXPERIMENTAL

Exufiber® and Mepilex® Border Flex

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No