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

Completed · Phase 3

Conditions studied: Inflammation, Burns, Ulcers

In brief

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.

Key facts

Study ID

NCT01214811

Run by

Molnlycke Health Care AB

People needed

27

Starts

2010-09-01

Expected to finish

2011-12-01

Last updated by the study team

2013-03-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Institute for advanced wound care — Momtgomery, Alabama, United States
• Burn treatment center — Iowa City, Iowa, United States
• Center for Curative & Palliative Care, Calvary Hospital — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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