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

NCT02167815 | Completed Results

• 1 other identifier: RedEgg 01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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.

Conditions

Venous Leg Ulcer (VLU)

Outcome Measures

Primary Outcomes (1)

• Changes From Baseline in Condition of the Peri Wound Skin

  Deteriorationin of skin condition , Mepilex XT and Standard care (%)

  16 weeks

Secondary Outcomes (3)

• Pain Scores on the Visual Analog Scale

  16 weeks

• Users Feedback After Handling or Use as a Measure of Performance.

  16 weeks

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

  16 weeks

Study Arms (2)

Standard care

ACTIVE COMPARATOR

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

Other: standard care

Intervention ( Mepilex XT)

EXPERIMENTAL

Device: Mepilex XT

Interventions

Mepilex XT DEVICE

Experimental arm

Intervention ( Mepilex XT)

standard care OTHER

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Molnlycke Health Care AB: lead

Study Sites (3)

Nemocnice Podlesí a.s.

Třinec, Konská 453, 739 61, Czechia

Location

Nemocnice Jihlava

Jihlava, Vrchlického, 586 01, Czechia

Location

The General University Hospital in Prague

Prague, Czechia

Location

MeSH Terms

Conditions

Varicose Ulcer

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: MuDr Jan Stryja
• Organization: Nemocnice Podlesí

Jan.stryja@atlas.cz

+420 558 304 111

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2014
• First Posted: June 19, 2014
• Study Start: May 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 26, 2016
• Results First Posted: October 26, 2016

Record last verified: 2014-05

Locations

CZ (3)