A Multicenter, Post Marketing Clinical Follow up (PMCF) Investigation to Evaluate the Performance and Safety of a Soft Silicone Foam Dressing and to Evaluate the Performance of Standard Care in Exuding Venous Leg Ulcers

Study Overview
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Brief Summary
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This investigation is a Post Marketing Follow-Up Study for Mepilex XT conducted as part of Mölnlycke Health Care's quality system. The primary objective is to evaluate the performance of the dressing when used as intended on exuding Venous Leg Ulcers (VLUs) in the inflammatory and granulating stages of the wound healing process.

Official Title
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A Multicenter, Post Marketing Clinical Follow up (PMCF) Investigation to Evaluate the Performance and Safety of a Soft Silicone Foam Dressing and to Evaluate the Performance of Standard Care in Exuding Venous Leg Ulcers

Conditions
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Venous Leg Ulcer (VLU)

Intervention / Treatment
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* Device: Mepilex XT
* Other: standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Venous Leg Ulcer Exuding wound Wound surface covered with sloughy tissue* (before debridement) Wound size ≥ 6 cm2 In case of multiple wounds, target wound must be ≥ 3cm distant from other wounds. Wound suitable for treatment with the relevant primary dressing** Male or female, 18 years of age and above Signed Informed Consent Sloughy tissue defined as wet, yellow-brown fibrinous tissue present in the wound bed ** Mepilex XT in the intervention group. Standard care in the observation group Exclusion Criteria: More than two products of 15 cm x15 cm needed to cover the whole wound and affected peri-wound area Wound cavity and/or fistula Full thickness burns Exposed tendons and/or fascia Bleeding wounds Malignant or fungating wounds Wound age > 12 months Use of antimicrobial dressings or topical agents such as antiseptics, local antibiotics and steroids within 7 days from inclusion on the wound intended to be included Untreated limb ischemia (according to investigator's judgement) at the time of inclusion Subject not suitable for the investigation according to the investigator's judgement Subject included in other ongoing clinical investigation which could interfere with this investigation, as judged by the investigator Known allergy/hypersensitivity to any of the components of the primary dressing

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard care<br>standard care ( such as alginate, hydrofiber or other treatment) | Other: standard care<br> <br> |
| Experimental: Intervention ( Mepilex XT)<br> | Device: Mepilex XT<br>* Experimental arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes From Baseline in Condition of the Peri Wound Skin | Deteriorationin of skin condition , Mepilex XT and Standard care (%) | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores on the Visual Analog Scale | Pain at baseline visit, compared with pain at week 16. VAS scale, minimum pain = 0, maximum pain = 100. | 16 weeks | 
| Users Feedback After Handling or Use as a Measure of Performance. | Investigator/Nurse and Subject evaluation of performance of the primary dressing ( n) Scale= Good , Very Good, Poor, Very Poor 1Ease of application, 2 Ease of removal, 3 Ability to retain exudate, 4 Adherence to healthy skin, 5 Confomability to be repositioned , 6 Overall satisfaction, 7 Dressing sticking to wound bed, 8 Presence of residues on the wound bed. 9 Presence of residues on the healthy skin. 10 Overall evaluation of change in periwound skin condition. | 16 weeks | 
| Measure of Actual Dressing Cost and Cost of Care, as Input for Health Economics Calculations. |  | 16 weeks |