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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Wound Heal
- Sponsor
- Molnlycke Health Care AB
- Enrollment
- 34
- Locations
- 7
- Primary Endpoint
- Wound progress measured by investigator evaluation
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Wound progress measured by investigator evaluation
Time Frame: Up to 12 weeks
Wound progress of exuding chronic wounds from baseline to last visit where Exufiber is applicable, up to 12 weeks.
Secondary Outcomes
- Change in granulation tissue of exuding chronic wounds captured through visual judgement by investigator/designee through a scale in percentage(Up to12 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)
- Device usability, wound fluid retention and dressing properties(Up to 12 weeks)
- Cost-effectiveness(Up to12 weeks)
- Wound progress measured by investigator evaluation(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)
- Subject's perception of pain and comfort(Up to12 weeks)
- Changes in peri-wound skin condition of exuding chronic wounds(Up to12 weeks)
- Dressing wear time(Up to12 weeks)