N/A
Completed N=30
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
Venous Leg Ulcer (VLU)
Source: ClinicalTrials.gov NCT02167815 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcomePrimary: Changes From Baseline in Condition of the Peri Wound Skin — 0; 0; 5.6; 16.7 percentage of subjects
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes From Baseline in Condition of the Peri Wound Skin |
0; 0; 5.6; 16.7; 11.1; 16.7 | — |
| SECONDARY Pain Scores on the Visual Analog Scale |
17.6; 24.0; 5.8; 12.0 | — |
| SECONDARY Users Feedback After Handling or Use as a Measure of Performance. |
21; 9; 5; 6; 0; 3 | — |
| SECONDARY Measure of Actual Dressing Cost and Cost of Care, as Input for Health Economics Calculations. |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT02167815). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.