Clinical trial NCT04960553: A PMCF Investigation on Exuding Chronic Wounds Using Exufiber® as Primary Dressing, and Mepilex® Border Flex/Comfort
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Wound Heal
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
First posted: 2021-07-14
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Wound progress measured by investigator evaluation
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Wound progress measured by investigator evaluation
timeFrame: Up to 12 weeks
measure: 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
timeFrame: Up to 12 weeks
measure: Change in necrotic/sloughy tissue of exuding chronic wounds captured through visual judgement by investigator/designee through a scale in percentage
timeFrame: Up to 12 weeks
measure: Change in granulation tissue of exuding chronic wounds captured through visual judgement by investigator/designee through a scale in percentage
timeFrame: Up to12 weeks
measure: Changes in peri-wound skin condition of exuding chronic wounds
timeFrame: Up to12 weeks
measure: Device usability, wound fluid retention and dressing properties
timeFrame: Up to 12 weeks
measure: Subject's perception of pain and comfort
timeFrame: Up to12 weeks
measure: Dressing wear time
timeFrame: Up to12 weeks
measure: Cost-effectiveness
timeFrame: Up to12 weeks
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Onze-Lieve-Vrouwziekenhuis
city: Jette
country: Belgium
facility: UZ Brussel
city: Porto
country: Portugal
facility: Unidade de Cuidados Continuados Ordem da Trindade
city: Póvoa De Varzim
country: Portugal
facility: Unidade Cuidados Continuados - Mutivaze - WeCare
city: Ashington
country: United Kingdom
facility: Northumbria Healthcare NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
city: Salford
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
Study officials:
References: