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

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Standard care	standard care	standard care ( such as alginate, hydrofiber or other treatment)
Intervention ( Mepilex XT)	Mepilex XT	-

Primary Outcome Measures

Name	Time	Method
Changes From Baseline in Condition of the Peri Wound Skin	16 weeks	Deteriorationin of skin condition , Mepilex XT and Standard care (%)

Secondary Outcome Measures

Name	Time	Method
Measure of Actual Dressing Cost and Cost of Care, as Input for Health Economics Calculations.	16 weeks
Pain Scores on the Visual Analog Scale	16 weeks	Pain at baseline visit, compared with pain at week 16. VAS scale, minimum pain = 0, maximum pain = 100.
Users Feedback After Handling or Use as a Measure of Performance.	16 weeks	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.

Locations (3): The General University Hospital in Prague
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Prague, Czech Republic
Nemocnice Podlesí a.s.
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Třinec, Konská 453, Czech Republic
Nemocnice Jihlava
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Jihlava, Vrchlického, Czech Republic