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

Molnlycke Health Care

Status: Completed

Conditions: Venous Leg Ulcer (VLU)

Treatments: Device: Mepilex XT; Other: standard care

Study type: Interventional

Funder types: Industry

Identifiers

NCT02167815

RedEgg 01

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Standard care

Active Comparator group

Description:

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

Treatment:

Other: standard care

Intervention ( Mepilex XT)

Experimental group

Treatment:

Device: Mepilex XT