Clinical trial NCT02167815: 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
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Leg Ulcer (VLU)
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
First posted: 2014-06-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Venous Leg Ulcer
2. Exuding wound
3. Wound surface covered with sloughy tissue\* (before debridement)
4. Wound size ≥ 6 cm2
5. In case of multiple wounds, target wound must be ≥ 3cm distant from other wounds.
6. Wound suitable for treatment with the relevant primary dressing\*\*
7. Male or female, 18 years of age and above
8. 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:

1. More than two products of 15 cm x15 cm needed to cover the whole wound and affected peri-wound area
2. Wound cavity and/or fistula
3. Full thickness burns
4. Exposed tendons and/or fascia
5. Bleeding wounds
6. Malignant or fungating wounds
7. Wound age \> 12 months
8. 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
9. Untreated limb ischemia (according to investigator's judgement) at the time of inclusion
10. Subject not suitable for the investigation according to the investigator's judgement
11. Subject included in other ongoing clinical investigation which could interfere with this investigation, as judged by the investigator
12. Known allergy/hypersensitivity to any of the components of the primary dressing

Primary outcomes:
measure: Changes From Baseline in Condition of the Peri Wound Skin
timeFrame: 16 weeks
Secondary outcomes:
measure: Pain Scores on the Visual Analog Scale
timeFrame: 16 weeks
measure: Users Feedback After Handling or Use as a Measure of Performance.
timeFrame: 16 weeks
measure: Measure of Actual Dressing Cost and Cost of Care, as Input for Health Economics Calculations.
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Třinec
country: Czech Republic
facility: Nemocnice Podlesí a.s.
state: Konská 453
city: Jihlava
country: Czech Republic
facility: Nemocnice Jihlava
state: Vrchlického
city: Prague
country: Czech Republic
facility: The General University Hospital in Prague
Study officials:
References: