An observational study in Venous or Mixed Leg Ulcers, sponsored by Lohmann & Rauscher. Completed at 1 site in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-02-19.
Sponsored by Lohmann & Rauscher · Observational
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
The patient population is patient with venous or mixed leg ulcers
Exclusion Criteria:
Use of Suprasorb® C collagen wound dressing is contraindicated according to the current IFU:
In addition following patients shall not be included into this study:
Progression of healing after application of Suprasorb® C collagen wound dressing is used as parameter for performance evaluation
Progression of healing after application of Suprasorb® C collagen
Time frame: Progression of healing is assessed at 8 weeks
Frequency and severity of adverse events
Frequency and severity of adverse events, incidences, as well as known risk and side effects, i.e. wound infection, side effects in the group of allergic disorders, pain, and maceration
Time frame: Frequency and severity is assessed up to 8 weeks
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Lohmann & Rauscher