Status:
COMPLETED
Post-Market Clinical-Follow-Up Study of Suprasorb® C Collagen Wound Dressing
Lead Sponsor:
Lohmann & Rauscher
Conditions:
Venous or Mixed Leg Ulcers
Eligibility:
All Genders
18-85 years
Brief Summary
Post-Market Clinical-Follow-Up Study of Suprasorb® C collagen wound dressing
Detailed Description
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 adver...
Eligibility Criteria
Inclusion
- Patient over 18 years of age and under 85 years of age
- Patient suffering from confirmed venous or mixed vascular leg ulcers
- Stagnating wound conditions, i.e. exudation phase \> 2 months, not responding to traditional dressing and standard treatment (standard treatment is a clear definition and for venous ulcers compression should be included)
- Target ulcers between 2 cm and 10 cm in the largest diameter
- Written confirmation from the study nurse that the patient was informed, orally agreed to participate and to comply with study treatment and planned visits
Exclusion
- Use of Suprasorb® C collagen wound dressing is contraindicated according to the current IFU:
- Clinically infected areas
- Presence of known allergies to one or several of its components.
- In addition following patients shall not be included into this study:
- Patient not covered by health insurance/social security
- Patient suffering serious life threatening disease
- Pregnant or breastfeeding women
- Minor patient, protected adult, person without liberty
Key Trial Info
Start Date :
January 24 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 23 2020
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT03444597
Start Date
January 24 2018
End Date
January 23 2020
Last Update
February 19 2020
Active Locations (1)
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1
RCTs
Lyon, France, 69002