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) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02167815
• Other study ID #: RedEgg 01
• Status: Completed
• Phase: N/A
• First received: May 15, 2014
• Last updated: September 7, 2015
• Start date: May 2014
• Est. completion date: July 2015

Study information

• Verified date: May 2014
• Source: Molnlycke Health Care AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer (VLU)

Intervention

Device:
• Mepilex XT
Experimental arm

Other:
• standard care

Locations

Country	Name	City	State
Czech Republic	Nemocnice Jihlava	Jihlava	Vrchlického
Czech Republic	The General University Hospital in Prague	Prague
Czech Republic	Nemocnice Podlesí a.s.	Trinec	Konská 453

Sponsors (1)

Lead Sponsor	Collaborator
Molnlycke Health Care AB

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with non-healthy peri-wound skin as a measure of performance.	Changes from baseline in condition of the peri-wound skin.	16 weeks	No
Secondary	Pain scores on the Visual Analog Scale		16 weeks	No
Secondary	Users feedback after handling or use as a measure of performance.	Investigator/Nurse and Subject evaluation of performance of the primary dressing Measure on a five point scale	16 weeks	No
Secondary	Measure of actual dressing cost and cost of care, as input for health economics calculations.		16 weeks	No
Secondary	Number of participants with adverse events, as a measure of safety.		16 weeks	No