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The study was early terminated because new data related to the investigational device were available making this investigation no longer scientifically relevant
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Onze-Lieve-Vrouwziekenhuis | Aalst | Belgium | ||||
| UZ Brussel |
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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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Dressing wear time | Dressing wear time of the Exufiber dressing and the Mepilex Border Flex dressing, and supporting techniques applied. | Up to12 weeks |
| Cost-effectiveness | Cost-effectiveness; wound care consumables and frequency of dressings changes. | Up to12 weeks |
| Jette |
| Belgium |
| Unidade de Cuidados Continuados Ordem da Trindade | Porto | Portugal |
| Unidade Cuidados Continuados - Mutivaze - WeCare | Póvoa de Varzim | Portugal |
| Northumbria Healthcare NHS Foundation Trust | Ashington | United Kingdom |
| Manchester University NHS Foundation Trust | Manchester | United Kingdom |
| Salford Royal NHS Foundation Trust | Salford | United Kingdom |