Mepilex Border Ag
DeviceMepilex Border Ag may be left in place for up to seven days, depending on the condition.
NCT Number: NCT01214811
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Institute for advanced wound care, Momtgomery, Alabama, United States
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)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Mepilex Border Ag may be left in place for up to seven days, depending on the condition.
Time frame: Baseline
Time frame: After one week
At each visit the wound length and width is measured and calculated in cm2.
Molnlycke Health Care AB
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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