Venous or Mixed Leg Ulcers Clinical Trial
Official title:
Post-Market Clinical-Follow-Up Study of Suprasorb® C Collagen Wound Dressing
Post-Market Clinical-Follow-Up Study of Suprasorb® C collagen wound dressing
Prospective, uncontrolled multi-center, observational cohort study. The objectives of the
PMCF study are confirmation of the performance, and to collect additional safety data
regarding expected adverse events and to detect potential unexpected adverse events
associated with use of Suprasorb®C under the conditions of routine use.
Suprasorb® C collagen wound dressing is a certified medical device (manufacturer: Lohmann &
Rauscher International GmbH & Co. KG). The product has been marketed in the EU since 1983 as
Opragen® (medicinal product), since 1995 as the medical device Opraskin® and since 2001 under
the name Suprasorb C (medical device).
Suprasorb® C is intended to be used as a wound dressing for the support of wound healing or
wound area reduction.
Participating Centers: 40 study nurses will participate to the PMCF Study Duration: 24 months
Cohort size: 110 patients Follow-up: 8 weeks
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