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

• ClinicalTrials.gov Identifier: NCT02167815
• Recruitment Status: Completed
• First Posted: June 19, 2014
• Results First Posted: October 26, 2016
• Last Update Posted: October 26, 2016
• Sponsor: Molnlycke Health Care AB
• Information provided by (Responsible Party): Molnlycke Health Care AB

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Venous Leg Ulcer (VLU)	Device: Mepilex XT; Other: standard care	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: May 2014
• Actual Primary Completion Date: July 2015
• Actual Study Completion Date: July 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Changes From Baseline in Condition of the Peri Wound Skin [ Time Frame: 16 weeks ]
   Deteriorationin of skin condition , Mepilex XT and Standard care (%)

Secondary Outcome Measures :

1. Pain Scores on the Visual Analog Scale [ Time Frame: 16 weeks ]
   Pain at baseline visit, compared with pain at week 16. VAS scale, minimum pain = 0, maximum pain = 100.
2. Users Feedback After Handling or Use as a Measure of Performance. [ Time Frame: 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.

3. Measure of Actual Dressing Cost and Cost of Care, as Input for Health Economics Calculations. [ Time Frame: 16 weeks ]

Eligibility Criteria

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

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

Contacts and Locations

Locations

Czech Republic

Nemocnice Podlesí a.s.

Třinec, Konská 453, Czech Republic, 739 61

Nemocnice Jihlava

Jihlava, Vrchlického, Czech Republic, 586 01

The General University Hospital in Prague

Prague, Czech Republic

Sponsors and Collaborators

Molnlycke Health Care AB

More Information

• Responsible Party: Molnlycke Health Care AB
• ClinicalTrials.gov Identifier: NCT02167815
• Other Study ID Numbers: RedEgg 01
• First Posted: June 19, 2014
• Results First Posted: October 26, 2016
• Last Update Posted: October 26, 2016
• Last Verified: May 2014

Additional relevant MeSH terms:

Varicose Ulcer; Leg Ulcer; Ulcer; Pathologic Processes; Skin Ulcer; Skin Diseases; Varicose Veins; Vascular Diseases; Cardiovascular Diseases