Open Multi-centre Investigation to Evaluate Signs and Symptoms of Local Inflammation/Infection on Chronic Ulcers and Partial Thickness Burns When Using Mepilex Border Ag as an Anti-microbial Wound Dressing

Molnlycke Health Care

Status and phase

Completed

Phase 3

Conditions

Inflammation

Burns

Ulcers

Treatments

Device: Mepilex Border Ag

Study type

Interventional

Funder types

Industry

Identifiers

NCT01214811

MxB Ag 01

Details and patient eligibility

About

The purpose of this study is to evaluate the change in signs of inflammation/local infection when Mepilex Border Ag is used in normal clinical practice when used on chronic ulcers (venous leg, diabetic foot and pressure ulcers) and partial thickness burns in need* of topical antimicrobial treatment according to the physician.

Full description

The investigation is designed as an open, non-controlled, post-marketing clinical follow-up. Subjects with chronic ulcers or partial thickness burns (including donor sites) at 2 sites will be included. Each subject with a chronic ulcer will be seen once a week for a maximum of 4 weeks or until desired treatment effect is obtained, whichever occurs earlier. Each subject with a partial thickness burn/donor site will be followed once a week for a maximum of 3 weeks or until desired treatment effect is obtained, whichever occurs earlier. All dressing changes will be done according to clinical routine practices and will follow IFU (instruction for use)

Enrollment

27 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject with a chronic ulcer (venous leg, diabetic foot and pressure ulcers) or a partial thickness burn where an antimicrobial action is indicated* as judged by the investigator
Male or female, 18 years and above, both in- and out-patients
Signed Informed Consent Form

Exclusion criteria

Wound size equal to or above 9.5x15cm for the wound/burn to be included in the investigation
Subject not expected to follow the investigation procedures
TBSA > 10% (partial thickness burns only)
HbA1C value > 7.2. (To be measured if BMI > 30)
Pregnant and breastfeeding women
Pressure ulcers deeper than stage 3
Deep pressure ulcers in need of a filler
Subjects with known sensitivity to silver or any other dressing materials
Subjects receiving radiation treatment or examinations e.g. X-ray, ultrasound, diathermy or Magnetic Resonance Imaging
Subjects using oxidising agents such as hypochlorite solutions or hydrogen peroxide
Subjects previously included in this investigation
Subjects included in other ongoing clinical investigation at present or during the past 30 days