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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

Primary Purpose

Venous Leg Ulcer (VLU)

Status
Completed
Phase
Not Applicable
Locations
Czech Republic
Study Type
Interventional
Intervention
Mepilex XT
standard care
Sponsored by
Molnlycke Health Care AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Leg Ulcer (VLU)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nemocnice Podlesí a.s.
  • Nemocnice Jihlava
  • The General University Hospital in Prague

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard care

Intervention ( Mepilex XT)

Arm Description

standard care ( such as alginate, hydrofiber or other treatment)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
Measure of Actual Dressing Cost and Cost of Care, as Input for Health Economics Calculations.

Full Information

First Posted
May 15, 2014
Last Updated
September 6, 2016
Sponsor
Molnlycke Health Care AB
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1. Study Identification

Unique Protocol Identification Number
NCT02167815
Brief 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
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

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Molnlycke Health Care AB

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcer (VLU)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
standard care ( such as alginate, hydrofiber or other treatment)
Arm Title
Intervention ( Mepilex XT)
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Mepilex XT
Intervention Description
Experimental arm
Intervention Type
Other
Intervention Name(s)
standard care
Primary Outcome Measure Information:
Title
Changes From Baseline in Condition of the Peri Wound Skin
Description
Deteriorationin of skin condition , Mepilex XT and Standard care (%)
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Pain Scores on the Visual Analog Scale
Description
Pain at baseline visit, compared with pain at week 16. VAS scale, minimum pain = 0, maximum pain = 100.
Time Frame
16 weeks
Title
Users Feedback After Handling or Use as a Measure of Performance.
Description
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.
Time Frame
16 weeks
Title
Measure of Actual Dressing Cost and Cost of Care, as Input for Health Economics Calculations.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Nemocnice Podlesí a.s.
City
Třinec
State/Province
Konská 453
ZIP/Postal Code
739 61
Country
Czech Republic
Facility Name
Nemocnice Jihlava
City
Jihlava
State/Province
Vrchlického
ZIP/Postal Code
586 01
Country
Czech Republic
Facility Name
The General University Hospital in Prague
City
Prague
Country
Czech Republic

12. IPD Sharing Statement

Learn more about this trial

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

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