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
| Status: | Archived |
|---|---|
| Conditions: | Other Indications, Hospital, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | September 2010 |
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.
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)
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