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

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.

Study Overview

• Status: Completed
• Conditions: Venous Leg Ulcer (VLU)
• Intervention / Treatment: Other: standard care; Device: Mepilex XT

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czech Republic
  • Prague, Czech Republic
    • The General University Hospital in Prague
  • Konská 453
    • Třinec, Konská 453, Czech Republic, 739 61
      • Nemocnice Podlesí a.s.
  • Vrchlického
    • Jihlava, Vrchlického, Czech Republic, 586 01
      • Nemocnice Jihlava

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Molnlycke Health Care AB

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: May 15, 2014
• First Submitted That Met QC Criteria: June 18, 2014
• First Posted (Estimate): June 19, 2014

Study Record Updates

• Last Update Posted (Estimate): October 26, 2016
• Last Update Submitted That Met QC Criteria: September 6, 2016
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: RedEgg 01