Open Multi-centre Investigation to Evaluate Signs and Symptoms of Local Inflammation/Infection on… (NCT01214811) | Clinical Trial Compass
CompletedPhase 3
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
United States27 participantsStarted 2010-09
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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