Post-Market Clinical-Follow-Up Study of Suprasorb® C Collagen Wound Dressing (Suprasorb®C)
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|ClinicalTrials.gov Identifier: NCT03444597|
Recruitment Status : Completed
First Posted : February 23, 2018
Last Update Posted : February 19, 2020
|Condition or disease|
|Venous or Mixed Leg Ulcers|
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
|Study Type :||Observational|
|Actual Enrollment :||111 participants|
|Official Title:||Post-Market Clinical-Follow-Up Study of Suprasorb® C Collagen Wound Dressing|
|Actual Study Start Date :||January 24, 2018|
|Actual Primary Completion Date :||January 23, 2020|
|Actual Study Completion Date :||January 23, 2020|
- Progression of healing after application of Suprasorb® C collagen wound dressing is used as parameter for performance evaluation [ Time Frame: Progression of healing is assessed at 8 weeks ]Progression of healing after application of Suprasorb® C collagen
- Frequency and severity of adverse events [ Time Frame: Frequency and severity is assessed up to 8 weeks ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03444597
|Lyon, France, 69002|
|Study Director:||Daria TROFIMENKO||Lohmann and Rauscher|